New data presented over the weekend at the European Society of Cardiology Congress 2011 show that Medtronic's ($MDT) CoreValve transcatheter aortic valve replacement system maintained its structural integrity and led to positive clinical outcomes over four years.
The study followed 50 patients--with an average age of 81 years--with native aortic valve disease who were implanted with the 21F CoreValve system in 2005 and 2006 at 7 centers in Europe and Canada. Investigators reported that cardiac survival was 77.9% at two years and 68% at four years. In addition, at four years, patients saw substantial improvement in heart failure symptoms. Eighty-seven percent were in NYHA Functional Class III or IV at the beginning of the study, but 61% had improved to Class 1 and 22% to Class II at four years, according to a company release. Valve performance was strong with no reported frame fractures or valve migrations.
"These results reinforce that CoreValve is a sound and stable valve that holds up to real-world use," said Peter den Heijer, interventional cardiologist at Amphia Hospital Breda in the Netherlands and an investigator in the study. "Almost more important, however, is that these patients--most of whom were old and very sick at the time of enrollment--saw such positive outcomes, including dramatic improvements in the activity level they could withstand, despite being some of the first patients in the world to undergo TAVI."
Since 2007, the CoreValve system has been implanted in patients in more than 40 countries, but is currently limited to investigational use in the U.S. The system is not approved in Canada and is available there through a special access program.
CoreValve is being studied in a U.S. clinical trial the company anticipates will be completed in 2012, heartwire notes. But surgeon Craig Miller, who is one of the investigators of the pivotal PARTNER trial of Edward Lifesciences' ($EW) Sapien transcatheter heart valve, told heartwire the results are "decent," but more data are needed on a larger group of patients.
Last month, the FDA's Circulatory System Devices Committee gave Edwards Lifesciences a win with a vote recommending Sapien. The company is awaiting the FDA's decision on the valve.
- get the Medtronic release
- see the heartwire coverage