Medtronic Inc. (NYSE:MDT) touted the latest results from studies of its CoreValve transcatheter aortic valve implantation system, which is two years behind competitor Edwards Lifesciences Corp. (NYSE:EW) in the U.S. market, at the European Society of Cardiology Congress 2011 conference in Paris today.
The CoreValve system is a minimally invasive treatment option for patients with severe heart disease who are at high risk or unable to undergo open-heart surgery.
The study followed 50 patients with aortic valve diseases who received CoreValve valve replacements in 2005 and 2006, and the device proved safe and effective after four years, the longest-term data available on any TAVI system to date.
Survival rate at two years was nearly 60 percent, and at four years it was about 45 percent. All patients saw improvement in their heart conditions, and there were no reports of fractures, valve migrations or valve deteriorations.
"These results reinforce that CoreValve is a sound and stable valve that holds up to real-world use," investigator Dr. Peter den Heijer said in the press release. "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."
The device is cleared in the European Union, but "looks like a 2014 product for the U.S.," Medtronic executive VP and cardiac and vascular group president Michael Coyle said at the annual shareholders meeting.
CoreValve began a U.S. pivotal trial in December 2010, and enrollment began in March. "We are very pleased with progress of the CoreValve U.S. Pivotal Trial, as all trial sites have been activated and many sites are actively enrolling and implanting patients," MDT spokesperson Kathleen Janasz told MassDevice.
That puts CoreValve two years behind competitor Edwards’ Sapien valve, which got a positive FDA panel vote in July. Edwards has staked its flag on an October 2011 release, sinking about $40 million into a launch that Edwards’ chairman & CEO Michael Mussallem said will allow the company to compete in 200 to 400 medical centers in the U.S.
Edwards and Medtronic have gone back and forth over valve patent disputes, most recently resulting in a $74 million patent infringement loss for Medtronic. A federal judge denied Edwards’ move to bar U.S. manufacturing and sales of CoreValve, which Medtronic acquired in in its $700 million buyout of CoreValve Inc. in 2009.
Here’s a roundup of recent clinical trial and scientific study news:
A pair of French studies were the first in Europe to demonstrate that remote patient monitoring is a safe and effective option for patients with implanted cardioverter defibrillators, and it may even be better than in-person evaluations.
One study concluded that using a home monitoring system for ICD patients reduced the number of inappropriate shocks by more than half, cut risk of hospitalization due to inappropriate shocks by nearly three-quarters and even improved battery life for the devices.
“The remote follow-up of patients implanted with an ICD seems to be a safe alternative to conventional in-office follow-up," said Dr. Philippe Mabo, one of the investigators and presenter at ESC 2011. "However, for the widespread uptake of this new strategy – at least in France – reimbursement from the healthcare system will be needed. We hope that it will be available soon in France.”
Abbott Laboratories’ (NYSE:ABT) MitraClip valve repair device proved safe and effective for patients who were too sick for surgery and who had consistently failed to respond to CRT therapy, according to research presented at ESC 2011 today.
In a study of 51 patients who all had severe mitral regurgitation as well as significant health problems that made them ineligible for surgery, 94 percent saw improvement one year after receiving MitraClip. The study also showed dramatic improvements in patient heart failure and ventricular function.
During follow-up, 4.2 percent of patients died within 30 days, and nine more died before the end of the study, most within six months.