Medtronic (NYSE:MDT) announced this week that its transcatheter aortic valve implantation (TAVI) system — CoreValve — had positive clinical outcomes in the longest, post-market follow-up in a published study of any TAVI device.
The device is designed to replace a diseased aortic valve without open-heart surgery.
The clinical trial of the heart valve catheter product conducted in 50 patients in Europe and Canada from 2005 and 2006 found that cardiac survival was 77.9 percent at two years while overall patient survival was at 58.5 percent. At four years, cardiac survival was at 68 percent with overall patient survival of 45.1 percent. The average age of patients was 81. The product’s structural integrity was also confirmed.
“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, in a news 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.”
In Europe, and in other parts of the world, Medtronic’s CoreValve competes with the Sapien system made by rival Edwards Lifesciences, a company with whom it has an ongoing legal dispute over transcatheter technology. Both have sued each other.
CoreValve is still a few years behind given that the Sapien system is expected to win approval from the U.S. Food and Drug Administration in the fall, according to an Edwards spokeswoman. In July, an FDA panel recommended its approval.
Medtronic for its part began a U.S. pivotal study of CoreValve in its third fiscal quarter of 2011, which began in November 2010.
The legal wrangling between the two companies is based on allegations of patent infringement. On April 10, 2010, Edwards Lifesciences announced that a jury ruled that Medtronic’s CoreValve had willfully violated its Andersen transcatheter valve patent and awarded the company $74 million in damages and allowed it to seek three times more than that amount. Edwards also decided to seek a permanent injunction prohibiting CoreValve from being sold. However, in February, those hopes were dashed when a district court judge denied the permanent injunction motion as well as prevented Edwards from seeking increased damages.
CoreValve and Sapien will vie for a target population of 100,000 Americans who suffer from severe aortic stenosis. About 30 percent of these patients cannot have open-heart surgery to replace their valve because the risk is too high. CoreValve was described as one of two of the “most exciting new technologies in medtech” by Medtronic CFO Gary Ellis in the company’s May 24 conference call with analysts.