Fletcher Allen Health Care today announced that on February 22 it successfully performed its first two patient implants in the Medtronic CoreValveUS Pivotal Trial.Fletcher Allen Health Care is one of 45 sites in the United States participating in an important clinical study evaluating the safety and effectiveness of a new technology that enables aortic valve replacement without traditional open-heart surgery.
Many patients with severe aortic stenosis are unable to receive surgical valve therapy. For patients at high-risk for open-heart surgery, this trial will study the efficacy of a less-invasive, percutaneous treatment option. Every high risk patient who is considered for the clinical trial will be evaluated by a comprehensive Heart Team including interventional cardiologists and cardiac surgeons.
This clinical trial, sponsored by Medtronic, aims to demonstrate the safety and efficacy of the Medtronic CoreValveSystem, an investigational technology that enables aortic valve replacement without the need for traditional open-heart surgery (Transcatheter Aortic Valve Implantation’TAVI). This system allows access to the diseased aortic valve via a femoral artery in the leg and does not require heart-lung bypass.
‘There is significant need for a new treatment option for patients with aortic stenosis, and it is enormously rewarding that Fletcher Allencan be part of evaluating this revolutionary new treatment optionin our community,’ said Harry Dauerman, M.D.,director, Cardiovascular Catheterization Laboratories at Fletcher Allen andprofessor, University of Vermont College of Medicine. ‘As the population ages,’ he continued, ‘the need for this procedure will continue to grow, as aortic stenosis is a condition that develops with age, and many people who are otherwise healthy could benefit significantly.’
In the U.S., the CoreValve System will not becommercially available until the successful completion of this clinical trial and approval by the U.S. Food and Drug Administration (FDA).The CoreValve System received CE (Conformité Européenne) Mark in Europe in 2007.
‘Because open-heart surgery is the most commonly available treatment option for these patients, and because the risks of surgery can be significant for many patients, the medical community is enthusiastic about the less-invasive option for these patients,’ said Dr. Dauerman.
About Aortic Stenosis
Aortic stenosis, which is most prevalent in the elderly population, inhibits blood flow between the heart and the body and causes symptoms such as shortness of breath, chest pain, fatigue and heart palpitations. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood and sometimes causes a back-up of blood into the lungs. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. Other than surgery, patients with this condition have had few, if any, successful treatment options.
Fletcher Allen. 4.2.2012.