FDA approves Medtronic heart valve replacement systemMedtronic Inc's minimally invasive system for replacing diseased heart valves won U.S. approval for use in patients deemed too frail to endure traditional open heart surgery, the U.S. medical device maker said on Friday.
By: Reuters, INFORUM
Medtronic Inc's minimally invasive system for replacing diseased heart valves won U.S. approval for use in patients deemed too frail to endure traditional open heart surgery, the U.S. medical device maker said on Friday.
The Food and Drug Administration approved Medtronic's CoreValve system based on U.S. clinical trials in which it was shown to be safe and effective while demonstrating low rates of stroke and valve leakage, the company said.
CoreValve, in which the replacement valve is threaded into place through an artery using a catheter - known as transcatheter aortic valve replacement, or TAVR - spares patients chest-cracking surgery, cutting down on recovery time. The system has been available since 2007 in Europe, where it is not uncommon for medical devices to win approval several years ahead of the United States.
CoreValve is expected to compete with the similar Sapien heart valve replacement system from rival Edwards Lifesciences Corp.
A U.S. jury earlier this week ruled on just how similar the two are, and CoreValve's U.S. sales prospects may hinge on further legal proceedings. The jury found that CoreValve infringes a patent held by Edwards and awarded Edwards more than $390 million in damages..
Medtronic vowed to appeal the decision and oppose any request for an injunction. Edwards, meanwhile, said the patent infringement ruling entitled it to seek increased damages of up to three times the value of the award.
The FDA approved CoreValve without first requiring an expert advisory panel to review the device and make recommendations to the agency.
"The low rates of stroke and valve leakage with the CoreValve System - two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life - set a new standard for transcatheter valves," Dr. Jeffrey Popma, director of Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston and one of the lead investigators of the pivotal clinical trial, said in a statement.
Medtronic shares were up 29 cents, or 0.5 percent, in late morning trade, while Edwards shares were off $3.20, or 4.4 percent, at $69.47, both on the New York Stock Exchange.