Edwards Lifesciences Corp., the Irvine-based heart valve maker, said Wednesday that nearly 1,100 European patients who received its Sapien less-invasive aortic valve had high survival rates 30 days after implantation.
Sapien, which is inserted with a catheter that? threaded inside the body and into the heart, and similar products are seen as the biggest development in heart valves in years. The valves eliminate the need for open-heart surgery.
Edwards released the study results at the EuroPCR Congress in Barcelona, Spain. The device maker said that patients who got Sapien through the femoral artery had a 30-day survival rate of 93.7%, while those who got the valve via a small incision between the ribs had a 30-day survival rate of 89.7%.
The device maker said the results were better than it had predicted for the patient group, which is considered high-risk and made up of older, very sick patients.
Catheter heart valves are seen as broadening the market to patients who are considered too old or too sick for major surgery.
Sapien, which is projected to have sales of more than $100 million this year in Europe, is in a major U.S. clinical trial with an eye on Food and Drug Administration approval in 2011.
Sapien could be big for Edwards ?analysts have estimated the market for less-invasive valves could reach $1 billion a year within 10 years of their launch.
