Medtronic's CoreValve heart valve performed so well in clinical trials that the FDA has chosen to forgo an advisory panel review and approve the product outright. In case you're keeping track, that milestone hit three months earlier than expected.
Courtesy of Medtronic
But CoreValve's U.S. future remains in question in the wake of a bitter ongoing patent battle with archrival Edwards Lifesciences ($EW).
The stakes are high. As The Wall Street Journal pointed out, transcatheter aortic valve replacement (TAVR) devices have already been on the European market for several years. What's more, industry observers see them as generating significant new revenue for cardiac devicemakers, in part if companies succeed in gaining approval for TAVR in less-critical patients, according to the story.
CoreValve is a transcatheter aortic heart valve, and regulators approved the implant in multiple sizes to treat patients with severe aortic stenosis who are too sick to have the valve replaced through the current standard method: open-heart surgery.
According to Medtronic ($MDT), the FDA approved CoreValve based on results from its U.S. pivotal trial. The one-year data released in October was pretty stellar: CoreValve patients experienced a 25.5% rate of death or major stroke, versus 43% from the standard surgery treatment. Interestingly, the stroke rate also landed nearly 41% lower than what was expected based on trial criteria developed with the FDA, Medtronic said. Patients at extreme risk for the surgery faced an 18% risk of major stroke, an excellent statistic for that class of patients, the company said.
CoreValve's early FDA approval is a big shot of good news for Medtronic. It also stands in contrast with the company's disclosure earlier in January that its highly touted Symplicity renal denervation device failed in a clinical trial to significantly lower blood pressure in patients with drug-resistant hypertension.
But Medtronic's CoreValve good news runs headlong into Edwards Lifesciences and its persistently aggressive battle to stop CoreValve both in the U.S. and overseas.
Edwards, which is trying to protect its market-leading Sapien transcatheter aortic heart valve, recently came out on top in a U.S. District Court patent trial. A jury ordered Minnesota-based Medtronic to pay at least $394 million in damages to Edwards, determining "willful" infringement. While Medtronic said it would appeal, Edwards promised to move to enforce the verdict and seek a permanent injunction against Medtronic and CoreValve in order to protect its Cribier family of patents, which was at the center of the case.
Another federal jury trial in 2010 found that CoreValve infringed Edwards' U.S. Anderson transcatheter heart valve patent. Medtronic made a $83.6 million payment in the matter last March.
In Europe, a German court in August issued an injunction on Medtronic CoreValve sales, handing Edwards another victory. That turned short-lived, however, when an appeals court overturned the decision.
- read the release
- here's the Wall Street Journal's take (sub. req.)