Medtronic (NYSE:MDT) said today that the FDA granted pre-market approval for its CoreValve replacement heart valve for extreme-risk patients, making it the 2nd medtech company to get a transcatheter aortic valve implant on the U.S. market.
Shares of Edwards Lifesciences (NYSE:EW), which has had the U.S. TAVI market to itself since October 2012, plunged 4% at the news, to $69.75 apiece as of about 11 a.m. today; MDT shares were trading at $59.46 apiece, up 0.6%.
The companies have been battling over TAVI technology in the courts in the U.S. and Europe for years. Earlier this week, Edwards won a $393 million judgment in a patent infringement lawsuit in Delaware. Medtronic said it would appeal the verdict. The FDA first approved the Sapien valve for low-risk patients.
Today Medtronic sought to highlight the difference between its CoreValve offering and the Sapien device made by Edwards. The CoreValve implant is designed to conform to the anatomy of each patient’s aortic valve to reduce the paravalvular leakage that’s plagued early-generation TAVIs such as the Sapien valve.
CoreValve, which Medtronic acquired for $700 million in 2009, posted low rates of valve leakage that decreased over time in a U.S. pivotal trial – "an improvement that has not been reported in other major [TAVI] studies," according to a press release.
The FDA’s PMA nod covers 4 sizes of the CoreValve device, ranging from the 23mm CoreValve Evolut to the 31mm size, according to the release. CoreValve won CE Mark approval in the European Union in 2007; since then, more than 50,000 implantations have been performed outside the U.S., Medtronic said.
"The FDA approval of CoreValve system is important for U.S. heart teams as the CoreValve system will serve the broadest spectrum of aortic stenosis patients who are unable to undergo surgery," structural heart president Dr. John Liddicoat said. "By leveraging Medtronic’s history and expertise in bringing therapies to patients, we are supporting heart teams through training and education, imaging and patient evaluation programs that exemplify our safe and deliberate approach to patient access."
The FDA decided last October not to convene an advisory panel for CoreValve after reviewing results from the pivotal trial. The study showed low rates of major stroke and all-cause mortality at 1 month and a year following implantation, with nearly 75% of patient participants alive and stroke-free at 12 months, said co-principal investigator Dr. Jeffrey Popma, who presented the results during a late-breaking session of the 2013 Transcatheter Cardiovascular Therapeutics symposium in San Francisco.
"The low rates of stroke and valve leakage with the CoreValve system – 2 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," Popma, of the Beth Israel Deaconess Medical Center in Boston, said today in a statement. "The CoreValve U.S. Pivotal Trial was rigorously designed and applied clinical best practices. The trial results have redefined optimal TAVR outcomes in the areas that matter most to physicians and their patients, and the results are especially remarkable given the complex medical conditions and extreme frailty of this population."
Medtronic is still working on FDA approval for CoreValve with high-risk patients, running another trial comparing it to open heart surgery, according to the release.
