Mountain View, CA - December 21 2010 - El Camino Hospital today announced its first patient implant in the Medtronic CoreValve U.S. Clinical Tria. El Camino Hospital is one of the first of 40 hospitals across the U.S. to participate in the trial, which is evaluating a revolutionary non-surgical, less-invasive procedure as a treatment alternative to open-heart surgery for patients with severe aortic stenosis.
"The Heart and Vascular Institute at El Camino Hospital is proud to have been chosen among a very select group of leading hospitals across the nation to participate in the CoreValve Trial," said Dr. James Joye, co-primary investigator (PI) of the CoreValve study and Director of Research and Education for the Heart & Vascular Institute at El Camino Hospital. "The CoreValve technology and the ability to perform aortic valve replacement without open-heart surgery represent the most significant advance in valvular heart disease in decades. Combined with our involvement with the clinical evaluation of the percutaneous mitral valve repair, the addition of CoreValve uniquely distinguishes the Heart and Vascular Institute as an epicenter for minimally invasive heart valve intervention."
Aortic stenosis prevents the heart's aortic valve from opening completely, thereby preventing healthy blood flow from the aorta to the rest of the body. Untreated, aortic valve stenosis leads to serious heart problems. Worldwide, approximately 300,000 people have been diagnosed with aortic stenosis (100,000 in the U.S.), and approximately one-third of these patients are deemed at too high a risk for open-heart surgery, the only therapy with significant clinical effect that is currently available in the United States.
In the clinical trial, physicians channel a catheter (thin tube) with a porcine, prosthetic valve through a small opening in the patient's femoral artery to reach the heart. The physician guides the CoreValve System to the aortic valve, where it self-expands to replace the diseased aortic valve; the procedure is completed without open-heart surgery or surgical removal of the native valve.
"A potentially new era in the treatment of severe aortic stenosis is on the horizon," said Dr. Vincent Gaudiani, co-PI of the CoreValve study and cardiovascular surgeon at El Camino Hospital. "We are excited to participate in the early clinical evaluation of the CoreValve technology and are hopeful this will become a new treatment option for patients suffering from aortic stenosis. Ultimately the goal is to improve survival rates for these very sick patients, for whom limited therapies are available today."
In the U.S., the CoreValve System will not be commercially 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.
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.