Drug for Erectile Dysfunction and Pulmonary Hypertension Improves Heart Function in Children and Young Adults With Single Ventricle Heart Disease

/PRNewswire/ -- Heart function significantly improved in children and young adults with single ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia.

Single ventricle defects are a collection of cardiac malformations that impair the heart's ability to pump blood. Examples include: tricuspid atresia, pulmonary atresia/intact ventricular septum and hypoplastic left heart syndrome.

The Fontan operation is a procedure that redirects systemic venous blood directly to the pulmonary arteries, bypassing the heart. It is the third surgery in a staged palliation for single ventricle heart defects.

Researchers hypothesized that sildenafil may help cardiac performance by directly improving the squeeze of the heart muscle and by allowing for better filling of the heart.

In this study, researchers randomized 28 children and young adults who had undergone the Fontan operation to receive placebo or sildenafil three times a day for 6 weeks. After a 6 week break, subjects were switched to the opposite treatment course. The researchers found significant improvement in heart performance during treatment with sildenafil.

"The enhanced heart performance may improve exercise performance and quality of life in these children and young adults," said David J. Goldberg, M.D., pediatric cardiologist at The Children's Hospital of Philadelphia, who presented the abstract today at the American Heart Association Scientific Sessions in Orlando, Fla.

Grants from The Mark H. and Blanche M. Harrington Foundation and from Big Hearts to Little Hearts provided funding for this study.

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Study Shows Machine Perfusion Significantly Improves Transplant Results

/PRNewswire/ -- A landmark study published December 31 in the New England Journal of Medicine (NEJM) demonstrates that use of a specially-designed machine to store kidneys for transplantation offers significant benefits in kidney survival and function when compared to those stored in a traditional "ice box", or cold storage. Unlike the icebox, the LifePort(R) Kidney Transporter monitors the temperature and vascular performance of the organ in real time, while preserving it by pumping the kidney continuously with a cold solution, even while the organ is being transported to its intended recipient.

"This important study confirms the critical role that transportable machine perfusion can play in improving kidney transplant outcomes," said David Kravitz, Chief Executive Officer of Organ Recovery Systems, the manufacturer of LifePort. "It also demonstrates that LifePort should have a central place in all transplantation programs, to help ensure the best possible patient outcomes."

The international trial enrolled kidney pairs from 336 consecutive deceased donors in Europe and randomly assigned one kidney to machine perfusion and the other to static storage. Results showed that the odds of a delay in kidney function post transplant were reduced by almost half when machine perfusion was used compared with static cold storage. Delay in kidney function, or DGF, is a factor that is known to adversely affect the long-term outcome of kidney transplantation. The study also showed that the LifePort kidneys were 48 percent less likely to fail within the first year post-transplant compared to those kidneys stored in the traditional box of ice prior to transplantation. This is the first randomized, prospective study to directly compare the two methods of storing and transporting organs for transplantation.

"For the first time in the United States, the number of those waiting for a life-saving transplant has passed 100,000," said Joseph Vassalotti, MD, Chief Medical Officer of the National Kidney Foundation. "Any new method like the one demonstrated in this study, that will help maximize the available organs and potentially reduce the need for re-transplantation, is vitally important for patients and the professionals who care for them."

More than 1.5 million people worldwide suffer from end stage renal disease, for which a kidney transplant is the preferred treatment option. With a continuing global shortage of organs for transplantation, it is important to find ways of increasing not just the number of kidneys available but also the quality of organs for transplantation to improve the long-term outcome for recipients. By improving the quantity and quality of organs for transplant, both improvements in clinical outcomes and cost savings to health systems are likely to occur.

The LifePort provides a sealed, sterile, protected environment where a physiologic solution is gently pumped through the kidney at cold temperatures to minimize damage while the organ is outside the body. The LifePort is lightweight and portable allowing organs to be perfused and evaluated from the time of recovery until transplant. It can travel unaccompanied by land or air, safely transporting the kidneys across town or between states.

About the Machine Preservation Trial

The Machine Preservation Trial was an investigator-driven study, run by an independent Scientific Steering Committee across The Netherlands, Belgium and Germany, with Eurotransplant (an international organ exchange organization) collaborating as study coordinators. The Machine Preservation trial was sponsored by Organ Recovery Systems of Chicago, USA, manufacturers of the LifePort Kidney Transporter.

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Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System

Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.

Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients expired.

The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.

Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk information related to percutaneous lead damage. Copies of this press release may be found on Thoratec’s website, www.thoratec.com, under Investor Relations/Press Releases.

Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).

FDA has been informed of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787
• Fax: 1-800-FDA-0178

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FDA Approves Entereg to Help Restore Bowel Function Following Surgery

The U.S. Food and Drug Administration approved Entereg (alvimopan) May 20, 2008, to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.

"Patients who have undergone abdominal surgery and are on pain medications often experience problems eliminating waste," said Joyce Korvick, M.D., deputy director, Division of Gastroenterology Products. "Entereg will help accelerate their recovery, improve bowel function, and get these patients back on a normal diet. As with all FDA-approved products, the agency will monitor Entereg throughout its life cycle."

FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.

In approving Entereg, FDA determined that a REMS is necessary to ensure that the benefits of Entereg outweigh its risks. The REMS will include restricting Entereg to inpatient use only, requiring that hospitals be specially certified, distribution of educational materials to health care professionals, and regular assessments of the effectiveness of the REMS.

Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-product of a patient taking opioid pain relievers, like morphine, prescribed after surgery which can slow or inhibit normal motility. Entereg works by blocking opioid effects in the bowel.

The recommended dose for Entereg is one 12 milligram (mg) capsule given just prior to surgery and then another 12 mg dose administered twice daily for up to 7 days or not to exceed 15 doses. The product will only be available to hospitals and will come in blister packs that are marked "HOSPITAL USE ONLY." Entereg is not approved for use in pediatric populations.

The safety and efficacy of Entereg in post-operative patients were demonstrated in five studies that included 2,177 patients, of whom 1,096 received Entereg and 1,081 received placebo. Bowel recovery times ranged from 10 to 26 hours shorter for Entereg-treated patients compared to placebo-treated patients in the five studies. The most common side effects reported were low blood calcium levels, anemia and gastrointestinal problems, including constipation, dyspepsia (heartburn) and flatulence (excess bowel gas).

FDA has reviewed a 12-month study of Entereg in patients treated with opioid medications for chronic pain. In this study, there were more reports of myocardial infarctions in patients treated with a 0.5 mg dose of Entereg twice daily, compared with placebo-treated patients. This imbalance has not been observed in other studies of Entereg, including studies in patients undergoing bowel resection surgery who took 12 mg of Entereg, twice daily for up to seven days. A causal relationship with Entereg and myocardial infarction has not been established.

Consumers and health care professionals are encouraged to report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Adolor Corporation, the manufacturer of Entereg, is based in Exton, PA. Adolor and GlaxoSmithKline, London, England, are collaborating on the development and marketing of Entereg.