The SAVI™ 6-1Mini breast brachytherapy applicator is the only brachytherapy solution for patients with small breasts, hard-to-reach lumpectomy cavities, or cavities close to the skin surface, according to a new study.

Physicist and lead researcher Serban Morcovescu, MS, DABR, presented these findings on the 6-1Mini device at the recent annual conference of the American Society for Radiation Oncology (ASTRO).

Morcovescu’s scientific poster was one of three such presentations on the SAVI applicator that were presented at the prestigious national meeting.

“The SAVI 6-1Mini applicator is the only implant solution for small lumpectomy volumes,” said Morcovescu, of Texas Oncology Denton, in Denton, Texas.

He compared the device to two other brachytherapy technologies, including another multi-lumen balloon device. “SAVI allows us to safely treat patients whose breast size, cavity size and/or skin distance would not allow the use of balloon applicators.”

According to the study, SAVI allowed proper dose optimization, excellent PTV coverage and acceptable skin sparing for all patients.

SAVI is implemented as part of breast conservation therapy, encompassing surgery to remove the breast cancer and follow-up radiation — in this case, radiation that is delivered inside the breast by brachytherapy. SAVI treatment is completed in just five days compared to the six weeks of treatment, five days a week, that are typically required by traditional, external-beam radiation treatment.

Morcovescu’s study evaluated seven patients who were ineligible for balloon brachytherapy due to small breast size, small cavity size or minimal distance between the cavity and skin surface. Balloon brachytherapy applicators cannot be used on smaller cavities or those close to the skin surface or other body structures.

The SAVI 6-1Mini was specifically designed to deliver radiation to small or hard-to-treat lumpectomy cavities. The device is not limited by restrictions on skin spacing or cavity volume, because its multi-catheter design enables physicians to carefully direct and modulate the radiation dose.

The two other posters presented at the conference were APBI Brachytherapy Device Stability and the Importance of Pre-faction Device QA, authored by Daniel Scanderbeg, Ph.D. and Catheryn Yashar, M.D., of Moores Cancer Center at University of California, San Diego; and Dosimetric Effects of Non-Symmetric Openings of Multi-Catheter Breast Brachytherapy Applicators, authored by Jay Reiff, Ph.D., of Hahnemann University Hospital.

The 51st annual ASTRO meeting was held Nov. 1-5, 2009, in Chicago. The SAVI applicator is made by Cianna Medical, Inc.

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Many of the lifestyle habits that children and adolescents develop — eating a diet high in fat and low in fruits and vegetables, being physically inactive or sedentary, and experimenting with tobacco and alcohol use — can have a major impact on their health later in life. Given that, psychologists with expertise in children’s health and behavior should be taking more of a lead role in helping young people develop good lifestyle habits early on and preventing these problems from occurring, says a researcher from Georgetown University Medical Center.

The scope of what child health psychologists can contribute to the health and well-being of children in our society is much broader than many have yet recognized, says Kenneth Tercyak, PhD, assistant professor of oncology and pediatrics and member of the Cancer Control Program at Georgetown’s Lombardi Comprehensive Cancer Center.

Among the leading causes of death in the United States are heart disease, cancer and diabetes, but actual causes of death — which are defined as lifestyle and behavioral factors such as smoking and physical inactivity — contribute to this nation’s leading killers Tercyak says.

“That means the choices that children and teenagers make early in life, and the activities that they engage in, can have serious implications for their physical health and well-being when they grow up,” he says. “Because these health-compromising behaviors are typically initiated when a person is young, there is a need to more effectively prevent their onset and reform public health approaches to prevention. That is where child health psychologists can help.”

“There is a pressing need to readdress prevention efforts targeted toward our nation’s young people and their families, and child health psychologists are well-poised to advance this mission,” says Tercyak, who authored an editorial on the subject published in the September 24 issue of the Journal of Pediatric Psychology.

“Specialists in childhood behavior have a lot of good expertise that should now be employed to play a greater role in disease prevention,” he says.

Many fields in and outside of public health have designed lifestyle and behavioral prevention programs, Tercyak says, but too few have been aimed at youngsters or fully taken into perspective the psychology of children.

“Increasingly, the energy in public health is being focused on the lives of children because we know these lifestyle habits form early and may carry forward into adulthood. Child health psychologists and other advocates for children’s health need to be more involved at all levels of prevention research, applied work, and policy making in helping young people adopt good self-care,” he says.

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About Lombardi Comprehensive Cancer Center

The Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center and Georgetown University Hospital, seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Lombardi is one of only 39 comprehensive cancer centers in the nation, as designated by the National Cancer Institute, and the only one in the Washington, DC, area. For more information, go to lombardi.georgetown.edu/.

About Georgetown University Medical Center

Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO), which is home to 60 percent of the University’s sponsored research funding.

Source: Becky Wexler

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Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced data from a Phase 2 clinical trial that demonstrated Positron Emission Tomography (PET) myocardial perfusion imaging with flurpiridaz F 18 provided superior image quality, diagnostic certainty and diagnostic performance for detecting coronary artery disease (CAD) compared to single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), the current standard for the non-invasive detection of CAD. The data also demonstrated a positive safety profile for PET imaging with flurpiridaz F 18. The data were featured today in a late-breaking presentation by Jamshid Maddahi, M.D., F.A.C.C., Professor of Molecular and Medical Pharmacology (Nuclear Medicine) and Medicine (Cardiology) at the David Geffen School of Medicine at UCLA, and Lead Principal Investigator of the study, at ICNC10 – Nuclear Cardiology and Cardiac CT Conference in Amsterdam.

“Overall, this enhanced diagnostic performance may lead to more accurate testing and more appropriate patient management decisions in comparison to other non-invasive diagnostic modalities and, as such, we see great value in proceeding to Phase 3 clinical trials.”

“Results from this Phase 2 trial show that PET myocardial perfusion imaging with flurpiridaz F 18 demonstrate a strong safety profile and is superior to SPECT imaging with respect to the quality of rest and stress images, certainty of image interpretation, and diagnostic performance as measured by standard ROC analysis for detecting CAD,” said Dr. Maddahi. “Overall, this enhanced diagnostic performance may lead to more accurate testing and more appropriate patient management decisions in comparison to other non-invasive diagnostic modalities and, as such, we see great value in proceeding to Phase 3 clinical trials.”

In the Phase 2 trial, 143 patients from 21 centers underwent rest and stress PET and SPECT myocardial perfusion imaging and were evaluated for safety. Of these patients, 86 underwent coronary angiography and formed the population for evaluating diagnostic performance. PET myocardial perfusion imaging was performed with flurpiridaz F 18 at rest and at stress utilizing pharmacological coronary vasodilation or treadmill exercise. It is important to note that flurpiridaz F 18 can be used in conjunction with treadmill exercise, which is not feasible with more commonly used alternative PET tracers for myocardial perfusion imaging.

Results showed that a significantly higher percentage of images were rated as either excellent or good quality with PET imaging, compared to SPECT imaging for stress images (98.8% vs. 84.9%, p
“The Phase 2 trial of PET imaging with flurpiridaz F 18 met all study objectives and we are very pleased with the study findings, which show a trend toward improved diagnostic performance compared to SPECT MPI for the detection of CAD,” said Dana S. Washburn, M.D., Vice President, Clinical Development and Medical Affairs at Lantheus Medical Imaging. “PET imaging has gained considerable support in the field of cardiovascular imaging, as it offers many advantages to SPECT imaging. Flurpiridaz F 18 shows great promise as a novel PET myocardial perfusion imaging tool and we look forward to initiating our Phase 3 clinical development program of flurpiridaz F 18 in the second quarter of this year.”

In March 2011, Lantheus received Special Protocol Assessment approval from the FDA for the Phase 3 trial of flurpiridaz F 18. The Phase 3 clinical development program will include two open-label, multicenter trials to assess the diagnostic efficacy (both sensitivity and specificity) of flurpiridaz F 18 PET MPI, compared with SPECT myocardial perfusion imaging in the detection of significant coronary artery disease. The trials will enroll a total of approximately 1,350 patients at approximately 100 sites globally. Coronary angiography will be the truth standard for all patients. The clinical development program includes hypotheses for superiority for sensitivity and non-inferiority for specificity with an adequate sample size to demonstrate superior specificity if present. An interim analysis will take place upon 50 percent enrollment of the first trial.

About Flurpiridaz F 18 Injection and Coronary Artery Disease

Flurpiridaz F 18 injection, a fluorine 18-labeled agent that binds to mitochondrial complex 1 (MC-1)1, was designed to be a novel myocardial perfusion PET imaging agent for the diagnosis of coronary artery disease (CAD). PET imaging with flurpiridaz F 18 has the potential to be a new clinical tool for the evaluation of myocardial perfusion that may better evaluate patients with known or suspected CAD in comparison to other non-invasive diagnostic modalities. CAD is the most common form of heart disease, affecting approximately 16.8 million people in the United States2. CAD is the leading cause of death in the United States for both men and women3. Each year more than half a million Americans die from CAD3.

About PET and MPI

Positron Emission Tomography, also called PET imaging or a PET scan, is a type of nuclear medicine imaging procedure4 that provides information about the function and metabolism of the body’s organs, unlike computed tomography (CT) or magnetic resonance imaging (MRI), which primarily show anatomy and structure5. Myocardial perfusion imaging (MPI) is a non-invasive test that utilizes a small amount of radioactive material (radiopharmaceutical) injected into the body to depict the distribution of blood flow to the heart. MPI is used to identify areas of reduced blood flow (perfusion) to the heart muscle. The test is typically conducted under both rest and stress conditions, after which physicians examine and compare the two scans and predict whether the patient has significant coronary artery disease6. Although single-photon emission computer tomography (SPECT) is most commonly used for MPI7, PET imaging has gained considerable support and use in the field of cardiovascular imaging, as it offers many advantages to SPECT, including higher spatial and contrast resolution, which results in higher image quality and improved diagnostic accuracy, accurate attenuation correction and risk stratification8.

1. Yalamanchili, P, Wexler, E, Hayes, M, Yu, M, MD, Bozek J, Radeke, H, Azure, M, Purohit, A, Casebier, DS, and Robinson, SP. Mechanism of uptake and retention of 18F BMS-747158-02 in cardiomyocytes: A novel PET myocardial imaging agent. Journal Nuclear Cardiology 2007 Nov-Dec;14(6):782-8.

2. Cleveland Clinic. Coronary Artery Disease – Risk Factors. See here. Accessed on March 8, 2010.

3. National Institutes of Health, National Heart, Lung, and Blood Institute. Coronary Artery Disease: Who Is At Risk. See here. Accessed on March 1, 2011.

4. Radiology Info. What is Positron Emission Tomography – Computed Tomography (PET/CT) Scanning. See here. Accessed on June 4, 2010.

5. National Institutes of Health. NIH Clinical Center. Positron Emission Tomography Department Overview. See here. Accessed on June 4, 2010.

6. Society of Nuclear Medicine. Procedure Guidelines for Myocardial Perfusion Imaging. Version 3.0 June 2002. See here.

7. Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion. Circ Cardiovasc Imaging. 2009; 2:412-424.

8. Heller, G, Calnon, D and Dorbala, S. Recent Advances in Cardiac PET and PET/CT Myocardial Perfusion Imaging. J Nucl Cardiol 2009; 16:962-9.

Source:

Lantheus Medical Imaging, Inc. Continue reading →

Cardiff has the highest incidence of Crohn’s Disease in the UK.

The University Hospital of Wales is conducting research into the condition with eminent gastroenterologist Dr Hawthorne of Cardiff and Vale NHS Trust who himself is part of a national study.

Researchers are analysing data from the last 25 years in an attempt to explain what could cause the condition to be more prevalent in Cardiff isolating such factors as diet, bacterial infection and genetic impact.

Cardiff born Brenda Chamberlain, 58, suffered for years with the embarrassing and painful symptoms of Crohn’s Disease. Her school life was blighted from the age of seven with constant trips to the toilet and pain.

“Because of the lack of understanding and sheer embarrassment of my condition, and prolonged periods of absence due to the illness, I left school with no qualifications.”

“It wasn’t until I was diagnosed years later with Crohn’s Disease and underwent surgery – an ileostomy – that I was able to return to study, go to night school for four years passing A levels and go to university in later life after raising a family. I am now a fully qualified Occupational Therapist working in the community for Rookwood Hospital part of Cardiff and Vale NHS Trust.

“When I was at school, from the late 1950′s onwards, little was known about the condition now understood to be Crohn’s Disease. As my condition involved up to 30 visits to the toilet a day, teachers and even my GP at the time, put it down to a nervous temperament.”
Years of frustration followed until Brenda was diagnosed with Crohn’s Disease and opted when the symptoms of diarrhoea and pain became virtually constant to undergo an ileostomy at the age of 40 years old.

Part of the large intestine is removed and an opening (stoma), is formed from the small intestine through the abdominal wall which is then fitted with a bag to collect waste. Brenda said:

“Fortunately medical understanding and healthcare provision for Crohn’s Disease and indeed Inflammatory Bowel Disease (IBD) in general has moved on considerably. Organisations such as the Ileostomy and internal Pouch Group offer support to those who have undergone or are about to undergo surgery.

“The before and aftercare delivered to people in the community or at hospitals via specialist stoma care nurses has improved vastly over the years.

“Companies such as Fittleworth (which provides a service delivering stoma care products to those who have undergone surgery and other stoma related needs) work hand in hand with the NHS providing additional support for IBD sufferers in the form of specialist stoma nurses who can advise those who opt for surgery in the lead up and immediate aftermath of the operation.

“Not all people suffer symptoms acute enough to justify surgery. Having part of your body removed is always going to be quite drastic and the objective of the ongoing research is to ultimately enable more people to manage the condition without surgery and find a cure.”

As well as being an Occupational Therapist Brenda is Chairperson and Secretary of the South Wales Ileostomy and Pouch Group. She said: “As an organisation we support people who are facing the prospect of surgery and in the early days following surgery, we promote awareness generally of what an ileostomy is. I have been freed from the more chronic Crohn’s Disease symptoms but I have a pouch attached to my body that needs to be considered.

“We often get enquiries from people wanting to travel abroad and before the increase of security measures at airports following 9/11 we were able to provide them with a certificate which meant they didn’t have to go through the embarrassment of having their luggage searched and stoma products being produced.

“That is now no longer possible but Fittleworth provide an international service which means stoma products can be delivered and visits from stomacare specialists arranged abroad using international partner companies through Fittleworth’s World Assist Alliance service.

“Bowel matters or continence matters are becoming more acceptable topics to discuss openly and in the press. To assist in this process for the last five years the South Wales IA branch has sponsored an award for the medical student with the best gastroentrology exam results and it has been very successful in promoting awareness and establishing links with the college of medicine in Cardiff.

“We recognise care and the work that the IA does is changing with the advent of the internet people are becoming better informed. The IA also has a “Young IA” group that provides support, social opportunities and networking for younger members who are due to or have undergone an ileostomy or related surgery”.

The NHS is working with the private sector, companies such as Fittleworth that supports specialist nurses across North East to provide continuing care and products for patients.

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The U.S. Department of Health and Human Services (HHS) today released the National Strategy for Quality Improvement in Health Care (National Quality Strategy). The strategy was called for under the Affordable Care Act and is the first effort to create national aims and priorities to guide local, state, and national efforts to improve the quality of health care in the United States.

“The Affordable Care Act sets America on a path toward a higher quality health care system so we stop doing things that don’t work for patients and start doing more of the things that do work,” said HHS Secretary Kathleen Sebelius. “American hospitals, doctors, nurses and other health care providers are among the best in the world. With this ground-breaking strategy, we are working with local communities and health care providers to help patients and improve the health of all Americans.”

The National Quality Strategy will promote quality health care that is focused on the needs of patients, families, and communities. At the same time, the strategy is designed to move the system to work better for doctors and other health care providers – reducing their administrative burdens and helping them collaborate to improve care. The strategy presents three aims for the health care system:

– Better Care: Improve the overall quality, by making health care more patient-centered, reliable, accessible, and safe.

– Healthy People and Communities: Improve the health of the U.S. population by supporting proven interventions to address behavioral, social, and environmental determinants of health in addition to delivering higher-quality care.

– Affordable Care: Reduce the cost of quality health care for individuals, families, employers, and government.

To help achieve these aims, the strategy also establishes six priorities, to help focus efforts by public and private partners. Those priorities are:

– Making care safer by reducing harm caused in the delivery of care.

– Ensuring that care engages each person and family as partners.

– Ensuring that each person and family are engaged as partners in their care.

– Promoting the most effective prevention and treatment practices for the leading causes of mortality, starting with cardiovascular disease.

– Working with communities to promote wide use of best practices to enable healthy living.

– Making quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models.

The strategy was developed both through evidence-based results of the latest research and a collaborative transparent process that included input from a wide range of stakeholders across the health care system, including federal and state agencies, local communities, provider organizations, clinicians, patients, businesses, employers, and payers. This process of engagement will continue in 2011 and beyond.

The National Quality Strategy is designed to be an evolving guide for the nation as we continue to move forward with efforts to measure and improve health and health care quality. HHS will continue to work with stakeholders to create specific quantitative goals and measures for each of these priorities. In addition, as different communities have different needs and assets, the strategy and HHS will empower them to take different paths to achieving these goals.

The National Quality Strategy is just one piece of a broader effort by the Obama Administration to improve the quality of health care, and will serve as a tool to better coordinate quality initiatives between public and private partners. For example, the Affordable Care Act established a new Center for Medicare and Medicaid Innovation that will test innovative care and service delivery models. These new models are being tested to determine if they will improve the quality of care and reduce program expenditures for Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).

Read the report here. For more information about the National Quality Strategy, visit here.

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Cardium Therapeutics (NYSE Alternext US: CXM) and its operating unit InnerCool Therapies, Inc., announced that Thomas E. Ahlering, M.D., Professor and Vice Chair of the Department of Urology at the University of California, Irvine, and a pioneer in robotic prostate surgery, presented “Physiology of Surgical Injury Following Robotic-Assisted Prostatectomy, Is There a Role for Hypothermia?” at the International Robotic Urology Symposium (IRUS) being held in Las Vegas, Nevada January 12-14, 2009. Dr. Ahlering presented data on the potential benefits of pelvic cooling during robotic-assisted prostatectomy surgery. He introduced and discussed the benefits of InnerCool’s new UroCool™ catheter system designed to induce localized cooling during both robotic and open prostatectomy surgeries. The Symposium, sponsored by the Henry Ford Hospital, Detroit, attracts internationally renowned physicians in robotic prostatectomy, female urology, gynecology, kidney, pediatric urology, and adrenal and single-port laparoscopy.

The findings presented by Dr. Ahlering and his colleague Dr. David S. Finley, M.D. using localized manual cooling techniques during robotic-assisted radical prostatectomy surgery indicated that cooling resulted in a significantly faster recovery of urinary continence following surgery. The results reported on 47 patients receiving hypothermia during robotic-assisted laparoscopic prostatectomy (hRLP) who were prospectively compared with a standard robotic-assisted laparoscopic prostatectomy (RLP) cohort of 666 controls. Pelvic cooling was achieved using cold irrigation and an endorectal cooling balloon cycled with 4 degrees Celsius saline. Urinary continence was defined as requiring no urinary pads. The return to continence was faster for the hRLP (hypothermia) group versus the RLP (control) group: median 39 days versus 59 days, respectively (p=0.002).

As a result of these early positive results using manual cooling techniques, InnerCool’s new UroCool Catheter System was developed and is being utilized in current studies to improve the ease of use and provide more cooling power, which may potentially further enhance clinical outcomes. It is believed that additional ongoing studies may offer the potential to demonstrate improved post-operative erectile function for patients as well. Drs. Ahlering and Finley’s clinical data on hypothermic radical prostatectomy was recently presented with an award at the European Robotic Urologic Symposium in Prague and their findings are now being published as a Rapid Communication in the medical journal Urology (in press). Dr. Ahlering has also been invited to present his data on prostate cooling at the Annual Meeting of the American Urological Association to be held April 25-30 in Chicago, IL.

The Company recently announced the enrollment of the first patient in a study of Hypothermic Radical Prostatectomy being conducted by Dr. Ahlering and his colleagues at the University of California, Irvine. Patients are being cooled with the UroCool™ system in a study designed to further evaluate the potential safety and benefits of localized cooling during robotic-assisted prostatectomy, which is now the most common surgical technique for prostate cancer. A regulatory application for FDA 510(k) clearance of InnerCool’s UroCool?¤ catheter is expected to be submitted in the first quarter of 2009.

The UroCool™ catheter is designed to be placed within the rectal cavity adjacent to the prostate during surgery and is used in conjunction with InnerCool’s Celsius Control Console which circulates cold saline in a closed loop within InnerCool’s UroCool catheter to allow for localized cooling. Drs. Ahlering and Finley believe that therapeutic cooling of the prostate gland and surrounding areas during prostate surgery (which includes both traditional open surgical approaches and the newer robotic-assisted technique) offers the potential to reduce tissue damage and inflammation and thereby provide a faster return of bladder control (continence) and possibly erectile function (potency) following surgery.

“We are pleased that Dr. Ahlering, one of the nation’s experts in the field of robotic-assisted prostate surgery, had the opportunity to present his findings of the benefits of cooling during robotic-assisted prostatectomy and to introduce InnerCool’s new investigational UroCool™ catheter system to other experts in his field. In late 2008, we announced the licensing of UroCool related technology from the University of California, Irvine, patient enrollment in the Hypothermic Radical Prostatectomy study being conducted by Dr. Ahlering and his associates, and our plans to submit a regulatory application for FDA 510(k) clearance for the new UroCool™ catheter in first quarter 2009,” stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies.

Prostate Cancer

According to the American Cancer Society, prostate cancer is the most common cancer in American men other than skin cancers. One in six men will develop prostate cancer in their lifetime, and in 2007 over 200,000 men were newly diagnosed with the disease. Fortunately, prostate cancer grows relatively slowly and 7 out of 10 men are diagnosed in the early stages of the disease before it has spread to other parts of their body, thus leading to significantly increased survival with proper treatment. While the underlying cause for the development of prostate cancer is still unknown, factors such as age, race, and lifestyle affect the probability of developing the disease. Of these, age is the strongest risk factor, and as life spans continue to increase, more men are surviving to an age at which prostate cancer is more prevalent. The chances of developing prostate cancer increases quickly after reaching age 50, and about 2 out of every 3 prostate cancers are found in men over the age of 65. The three treatment approaches to prostate cancer are ‘watchful waiting,’ radiation, or surgery, depending on patient age, and how advanced the disease is.

Radical Prostatectomy

Radical prostatectomy is an effective means of eradicating prostate cancer by surgically removing the entire prostate and surrounding tissue. It is a complex procedure because the prostate gland is located deep inside the pelvis and is intimately associated with delicate nerves that control erections and bladder control. Historically, radical prostatectomy has been performed as an open procedure requiring surgical precision to preserve these important functions. Robot-assisted laparoscopic radical prostatectomy emerged with the introduction of systems such as the da Vinci?? Surgical System (a product of Intuitive Surgical, Inc.), which is minimally invasive and enables a high degree of precision. Since 2000, over 900 of such systems have been installed in hospitals worldwide, of which more than 700 are located in North America. Estimates show that more than 90,000 radical prostatectomies were performed in 2007 in the United States. Currently it is estimated that more than 70% of radical prostatectomies are performed robotically.

Post-Operative Incontinence and Erectile Dysfunction

Urinary incontinence and erectile dysfunction are very common side effects following open or robotic radical prostatectomy. Temporary loss of bladder control occurs in most men. While most eventually regain full control, this can take up to a year. This extended lack of urinary control is the most bothersome patient-reported side effect of prostate surgery. In addition to incontinence, many men experience some degree of erectile dysfunction following radical prostatectomy, depending on a number of factors including how potent the patient was prior to surgery, patient age, tumor stage, and how the neurovascular bundles were preserved during surgery. This side-effect is a frustrating and inconvenient experience. In many cases, the recovery of sexual function can take up to 24 months.

Additional Targeted Tissue Cooling

In addition to use in radical prostatectomies, targeted tissue cooling as developed for the UroCool catheter has a number of potential future clinical applications for tissue cooling in the pelvic region. These include other urological procedures such as radical cystectomy, a common procedure used to treat bladder cancer that has spread into the bladder wall. There are also a number of gynecological and colorectal cooling opportunities, including radical hysterectomy, myomectomy for removing fibroids from the uterus, and various types of transvaginal surgery.
About Cardium

Cardium Therapeutics, Inc. and its subsidiaries, InnerCool Therapies, Inc. and the Tissue Repair Company, are medical technology companies primarily focused on the development, manufacture and sale of innovative therapeutic products and devices for cardiovascular, ischemic and related indications.

Cardium’s InnerCool Therapies subsidiary is a San Diego-based medical technology company in the emerging field of temperature modulation therapy to rapidly and controllably cool the body in order to reduce cell death and damage following acute ischemic events such as cardiac arrest or stroke, and to potentially lessen or prevent associated injuries such as adverse neurological outcomes. For more information about Cardium’s InnerCool subsidiary and patient temperature modulation, including InnerCool’s new RapidBlue™ System, which just received FDA clearance, and its CoolBlue™ System, please visit innercool.

Cardium also has two biologic candidates in clinical development. Cardium’s Tissue Repair Company subsidiary (TRC) is focused on the development of growth factor therapeutics for the treatment of severe chronic diabetic wounds. TRC’s lead product candidate, Excellarate™, is a DNA-activated collagen gel for topical treatment formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-BB (PDGF-BB). Excellarate™ is initially being developed to be administered once or twice for the potential treatment of non-healing diabetic foot ulcers. Other potential applications for TRC’s Gene Activated Matrix™ (GAM) technology include therapeutic angiogenesis (cardiovascular ischemia, peripheral arterial disease) and orthopedic products, including hard tissue (bone) and soft tissue (ligament, tendon, cartilage) repair. For more information about Cardium’s Tissue Repair Company subsidiary, please visit t-r-co.

Cardium’s Generx product candidate (alferminogene tadenovec, Ad5FGF-4) is a DNA-based growth factor therapeutic being developed for potential use by interventional cardiologists as a one-time treatment to promote and stimulate the growth of collateral circulation in the hearts of patients with ischemic conditions such as recurrent angina. For more information about Cardium Therapeutics and its businesses, products and therapeutic candidates, please visit cardiumthx.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that results observed in one study or using one type of product or procedure will be replicated in subsequent studies or in studies using newly-developed products or procedures, that planned product development efforts and clinical studies can be performed in an efficient and effective manner, that regulatory approvals can be obtained in a timely manner or at all, that partnering, distribution or other commercialization efforts can be achieved and if so that they will effectively accelerate InnerCool’s patient temperature modulation business or market, that product modifications or launches will be successful or that the resulting products will be favorably received in the marketplace, that our products or proposed products will prove to be sufficiently safe and effective, that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive, that results or trends observed in one clinical study will be reproduced in subsequent studies, that third parties on whom we depend will behave as anticipated, or that necessary regulatory approvals will be obtained. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development, testing and marketing of therapeutic hypothermia devices and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new devices and systems and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Cardium’s Generx Continue reading →

Children who are bullies or have conduct problems at school, are more likely to be sleepy during the day according to University of Michigan Medical School researchers.

Researchers looked at elementary school students in the Ypsilanti, Michigan public schools who had exhibited conduct problems like bullying or discipline referrals and found that there was a two-fold higher risk for symptoms of sleep-disordered breathing, particularly daytime sleepiness among these students. The study was published last week in the journal Sleep Medicine.

“What this study does is raise the possibility that poor sleep, from whatever cause, can indeed play into bullying or other aggressive behaviors a major problem that many schools are trying to address,” says Louise O’Brien, Ph.D., assistant professor in U-M’s Sleep Disorders Center and the departments of Neurology and Oral and Maxillofacial Surgery.

“Our schools do push the importance of healthy eating and exercise, but this study highlights that good sleep is just as essential to a healthy lifestyle.”

O’Brien said the study showed that sleepiness seemed to be the biggest driver of the behavior problems, not the snoring, which is often a more obvious symptom associated with sleep-disordered breathing.

Sleep-disordered breathing is an umbrella term for a spectrum of breathing problems during sleep, which range from habitual snoring to obstructive sleep apnea, where the airway collapses at night.

The sleepiness experienced by the children in the study could be caused by sleep-disordered breathing, but also by many other factors like chaotic home environments, fragmented sleep or not enough sleep because of too much electronic stimulus from televisions, cell phones or computers in the bedroom, says O’Brien, who is on the faculty of U-M’s Sleep Disorders Center.

O’Brien says that a longitudinal study is needed. Although there are other reasons for these behaviors, if sleepiness does contribute to aggressive behavior as this study suggests, a significant proportion of bullying in children might be eliminated by efforts to reduce children’s daytime sleepiness.

“We know that the pre-frontal cortex area of the brain is sensitive to sleep deprivation, and this area is also related to emotional control, decision making and social behavior,” says O’Brien.

“So impairment in the prefrontal cortex may lead to aggression or disruptive behavior, delinquency or even substance abuse. But the good news is that some of these behaviors can be improved. Sleep-disordered breathing can be treated, and schools or parents can encourage kids to get more sleep.”

O’Brien recommends parents remove electronic devices from bedrooms, make getting enough sleep a priority and encourage children to sleep for the recommended amount of time without interruption. It is recommended that children in pre-school sleep between 11-13 hours a night, and school-aged children between 10-11 hours of sleep a night.

“Given the high prevalence of aggressive, bullying and disruptive behaviors in schools and the long-lasting consequences for both perpetrators and victims, more study on this issue is needed,” she says.

Source: University of Michigan Health System Continue reading →

Quality Associates, Inc. (QAI), an established provider of services and solutions for large-scale document management, imaging, and archiving, announced the launch of its H1N1 Flu Vaccine Forms Processing Service, a comprehensive approach to help states, cities, counties, and providers in the private sector successfully and accurately capture and record essential demographic and health data from medical consent forms – a critical step in the administration of the H1N1 vaccine to millions nationwide beginning this fall.

As part of the two-step inoculation process, each patient is required to fill out a printed medical consent form before each shot is given. More than 100 million vaccinations are expected to become available this fall, which is creating a serious and urgent need for states, municipalities and the private sector to immediately develop a clear strategy to effectively capture vital personal and healthcare-related information. Once information is collected, it must be converted into a useable electronic format for insurance, reporting, and statistical needs. Without a digital capture methodology in place, municipalities and private healthcare providers risk losing funds due to lost or inaccurate recipient insurance information. Additionally, government agencies such as the Centers for Disease Control and Prevention could lose important data regarding vaccine distribution and efficacy.

QAI’s H1N1 Flu Vaccine Forms Processing Service involves several steps that ensure information is captured and recorded accurately:

- Step 1 – Consultation: QAI works closely with vaccine administrators to understand the scope of each project, and then helps guide the entire process.

- Step 2 – Forms Design: Using experience gained by processing millions of healthcare forms collected during the administration of the yearly flu vaccine, QAI designs user-friendly forms that collect information as completely and accurately as possible.

- Step 3 – Forms Processing: QAI uses state-of-the-art high-volume scanners, intelligent data recognition software, and technology to capture information on each form. Quality assurance steps ensure the accuracy of all captured data. Additionally, QAI’s controlled, on-shore processing protects sensitive patient information.

- Step 4 – Data Integration: QAI submits all original documentation and captured data back to the client. Data can be provided in one of several formats to ensure compatibility with the provider’s own systems.

Scott Swidersky, director, Information Systems, Quality Associates, Inc., said, “At this moment, every state, local government, and private firm involved in the H1N1 vaccine administration is facing numerous, complex logistical and technical hurdles that must be resolved quickly. In a matter of weeks, the H1N1 vaccine will become available and administration will begin. From a data capture standpoint, QAI is in the unique position of having the vast experience required to successfully pull information from millions of hard-copy documents. We have processed millions of forms used in the administration of yearly flu programs, and are ready to lend our expertise to help in the nationwide H1N1 vaccine administration effort.”

Source
Quality Associates, Inc. Continue reading →

A quarter of health visitors in England fear that ‘another Victoria Climbie’ could happen in their NHS trust, new research from Unite, the country’s largest trade union, revealed today (Thursday, 18 September).

The survey by Unite/Community Practitioners’ and Health Visitors’ Association of 829 health visitors in England revealed 25% thought the chances of a repetition of the fate of the eight-year old girl tortured to death by her great-aunt and her boyfriend happening in their NHS trust was ‘very likely’ or ‘somewhat likely’.

Unite has been strongly campaigning against the swingeing cuts in the health visitor workforce in recent years, which according to the NHS’s own workplace statistics, has seen ‘a health visitor job being lost every 27 hours’.

Unite’s National Officer for Health, Karen Reay said: ‘These findings are a terrible indictment, which demonstrate that the health visiting profession is on the ropes. Families and communities will suffer as a result, which is completely the reverse of what the government’s ‘family-friendly’ policies are intended to promote.’

‘We are calling for ministers to instruct NHS trusts to implement a massive investment programme in health visiting so that government policies can come to fruition, and to restore the cuts in training budgets to guarantee the next generation of health visitors.’

Other findings include:

- More than 40% of health visitors are responsible for more than 500 children and nearly 20% for more than 1,000.

- Almost 70% of health visitors can’t currently meet the needs of the most vulnerable children.

The Unite/CPHVA report comes out on the same day as one from Netmums, the UK’s largest parenting website, which showed that 60% of the 6,000 mothers in its survey said they didn’t see their health visitor enough during the first year of their child’s life.

Unite/CPHVA’s Lead Professional Officer for Strategy and Practice Development, Cheryll Adams said: ‘It is no coincidence that two separate organisations have come to the same conclusion – that health visitors are crucially important to the future well-being of the UK’s children. We call on the government to act now on these two reports.’

- Victoria Climbie died in 2000, aged eight, after being tortured by her great aunt and her boyfriend. This resulted in the Lord Laming inquiry

Unite/CPHVA press releases can be seen on the CPHVA website: unitetheunion/cphva

Unite is the largest union in the UK. It has seven professional sections: the Community Practitioners’ and Health Visitors’ Association, the Mental Health Nurses Association, the Guild of Healthcare Pharmacists, the Society of Sexual Health Advisers, the Medical Practitioners’ Union, College of Healthcare Chaplains, and the Hospital Physicists Association.

Unite was formed by an amalgamation of Amicus and the Transport and General Workers’ Union in May 2007.

Unite The Union Continue reading →

Promoting longer, more regular sleep, even catching up at weekends on sleep lost in the week, may help reduce the
incidence of childhood obesity, concluded US researchers in a new study published online in a leading journal this
week.

You can read how Dr David Gozal, Professor and Chair of the Department of Pediatrics at the University of Chicago Medical
Center, Chicago, Illinois, and colleagues, arrived at this conclusion in a paper published online on 24 January in the journal
Pediatrics.

Previous studies have already reported that insufficient sleep is linked to an increased risk of obesity in children, but in this study,
Gozal and colleagues set out specifically to explore the effect of duration and regularity of sleep on BMI and metabolic regulation
in children.

BMI stands for Body Mass Index, a measure of obesity, expressed in kg per meter squared, and equal to a person’s weight
divided by the square of their height.

For this cross-sectional study, they recruited 308 community-resident children aged 4 to 10 years, and measured their BMIs, their
blood glucose before eating in the morning, insulin, blood fats and cholesterol. In a sub-sample group, they also measured levels of high-sensitivity C-reactive protein (an “inflammation” marker used to assess risk of cardiovascular disease).

The children wore wrist monitors for a week. These measured physical activity and allowed the researchers to assess how
often, when the children slept, and how long for, over the week.

The results showed that:

The children slept for 8 hours every night on average, regardless of their BMI.
However, there was also a non-linear trend between sleep and weight.
The children in the obese BMI range, slept fewer hours and showed greater variability in the differences between weekend
sleep time and school days sleep time.
Children whose BMI was in the overweight range, showed an inconsistent sleep pattern.
Analysis of sleep patterns and blood markers showed that high variance in sleep duration, or shorter sleep duration, was more
likely to be linked to altered levels of insulin, LDL cholesterol, and high-sensitivity C-reactive protein.
Children who slept the least, particularly those who also had irregular sleep patterns, showed the greatest health risk (ie the
riskiest combination of BMI and blood markers).

The researchers found that just an extra half hour of sleep every night was linked to lower BMI and reduced pattern of risky
blood markers.

And they also found that catching up with sleep at the weekend was linked to a lower risk of obesity, they wrote that:

“Obese children were less likely to experience ‘catch-up’ sleep on weekends, and the combination of shorter sleep duration and
more-variable sleep patterns was associated with adverse metabolic outcomes.”

They concluded that:

“Educational campaigns, aimed at families, regarding longer and more-regular sleep may promote decreases in obesity rates and
may improve metabolic dysfunction trends in school-aged children.”

“Sleep Duration, Sleep Regularity, Body Weight, and Metabolic Homeostasis in School-aged Children.”
Karen Spruyt, Dennis L. Molfese, David Gozal.
Pediatrics, Published online 24 January 2011
DOI:10.1542/peds.2010-0497

Additional source: Cleveland Clinic (online health information services).

: Catharine Paddock, PhD

Continue reading →