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First Heart Valve Not Requiring Open-Heart Surgery
The Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System is the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

Conduits are surgically implanted valves used to treat congenital heart defects of the pulmonary valve. Patients with congenital heart defects have narrowed, leaky, or missing pulmonary valves that impede the proper flow of blood from the heart’s right ventricle to the pulmonary artery, which then sends the blood on to the lungs for oxygenation. Conduits can have a limited lifespan and often require replacement. The Melody is intended to provide another option to conduit replacement.

"The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition," said Jeffrey Shuren, J.D., M.D., director of the FDA’s Center for Devices and Radiological Health. "Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients."

Like other valves, the Melody does not cure the heart condition and over time, the Melody may wear and require replacement. However, it is implanted without open heart surgery, can prop open the poorly functioning conduit, and can keep blood flowing in the proper direction because of the tissue valve in the Melody. These characteristics will allow a patient’s conduit to function longer than usual, which can delay the need for more invasive open-heart surgery.

Approval of the Melody valve should be especially beneficial to pediatric patients with right-sided valvular heart disease who may face several surgeries over their lifetimes.
Clinical studies of 99 participants in the United States and 68 participants in Europe showed that the device improved function of the heart, and the majority of participants have noted improvements in their clinical symptoms. The device showed similar, limited durability compared with existing alternative treatments; 21 percent of U.S. participants experienced a stent fracture, a rate consistent with stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve.

As a condition of the FDA’s approval, the system’s manufacturer, Medtronic Inc. of Minneapolis, will conduct two post-approval studies to assess long-term risks and benefits as well as to evaluate the physician specialization needed to perform the implantation procedure, also called generalizability. One study will continue to follow 150 participants from the initial clinical trial for five years, and the second study will enroll more than 100 new participants to be evaluated over five years, in order to evaluate and assess the training program. Safety and benefit assessments will be part of both studies. The FDA also requires that Medtronic maintain a database of Melody recipients.

The FDA approved the Melody under the Humanitarian Device Exemption (HDE) program, which supports the development of medical devices intended to benefit patients in the treatment or diagnosis of diseases or conditions affecting fewer than 4,000 people in the United States per year. Under an HDE, the FDA can approve a device for limited use if there is a reasonable assurance that the device is safe and if the probable benefit to health outweighs the risk of injury or illness. Such products can only be used at medical institutions with an overseeing Institutional Review Board.

Manufacturers of most HDE devices are prohibited from selling their device for an amount that exceeds the costs of research and development, fabrication and distribution of the device. However, this prohibition does not apply to an agency-specified number of Melody devices sold each year and intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients, due to a provision in the Pediatric medical Device Safety and Improvement Act of 2007.

Website Address: http://online.wsj.com/article/BT-CO-20100125-711169.html?mod=WSJ_latestheadlines
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Please note that all Travel Nursing Opportunities listed on this New York Travel Nurses web site are subject to change. Please contact a Recruiter at New York Travel Nurses today at (888) 894-2900 to find out about the most current Travel Nursing opportunities that are available. RNs need the appropriate experience for all Travel Nursing Jobs that are offered on this site. The New York Travel Nursing Assignments listed within this site are all a minimum of thirteen weeks in duration. Once you agree to accept one of these New York Travel Nursing Assignments, your particular Assignment length of time and the hours will be guaranteed as part of a written Employment Agreement. This guarantee will make you comfortable that you are receiving exactly what you agreed to upfront. You cannot be cancelled during this thirteen week Travel Nursing Assignment due to a low patient census. This will enable you to budget your finances efficiently without worry. Once you complete one of these New York Travel Nurse Assignments you can elect to continue your travel adventure at another Hospital, or continue at the same Hospital if the staffing need continues. You may also decide to accept a permanent position with the Hospital if that is your desire. The choice is entirely yours. When you work as a Travel Nurse at one of the New York Travel Nurse Assignments listed within this site, you will receive a premium salary and top notch health, life and disability insurance. Health Insurance for these New York Travel Nurse Assignments is 100% company paid. Employee Life/AD&D Benefits associated with these New York Travel Nurse Assignments are $25,000. Dental, Vision and Prescription Benefits are included as part of the benefits package associated with each of these New York Travel Nurse Assignments. For all of the New York Travel Nurse Assignments listed within this site, there are no Networks (use legitimate caregiver of choice), and there is no Medical Underwriting. There is a comprehensive 401(k) Plan for all New York Travel Nurse Assignments that includes 100% Company Matching, Immediate Vesting and Immediate Eligibility. As an New York Travelling Registered Nurse for the Assignments listed here, YOU decide your what housing best suits you. You have the choice of free private housing or a monthly housing stipend to cover housing expenses that you incur during your New York Travel Nursing assignment. All New York Travelling Registered Nurses receive a generous bonus for any RN who is referred that accepts one of the New York Travel Nurse Assignments listed on this site.
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