This week, two titans in transcatheter aortic valve replacement (TAVR) settled a feud over patents. One beneficiary of that agreement may be TAVR itself.
Edwards Lifesciences had claimed that Medtronic infringed on a family of patents related to its Sapien TAVR valve. Edwards was the first to market in the U.S., winning FDA approval for Sapien as a treatment for inoperable patients with severe aortic stenosis. The FDA later expanded the indication to include high-risk patients.
Medtronic received FDA approval earlier this year for its CoreValve device in what it had described as extremely high-risk patients. A clinical trial evaluating its safety and efficacy in high-risk patients, presented at ACC.14, was favorable. That has set the stage for regulators to review CoreValve for this patient population.
In April, a federal court judge overseeing the patent dispute granted a preliminary injunction that limited the use of CoreValve, which he later delayed in an effort to get the two sides to find a solution that would make both valves available.
This was an anguishing period for cardiac surgeons and others involved in heart teams. One surgeon told me that after the injunction he had to call every patient scheduled to undergo TAVR with a CoreValve and tell them it was a no-go. That has changed with the settlement, which calls for Medtronic to fork over a one-time fee of $750 million and pay royalty fees through 2022.
It is possible that one valve or the other may be better suited for an individual patient. Like most technologies, the devices also go through iterations that may mean a smaller profile or other improvements. Options offer a way to provide more individualized care.
Having more than one device also infuses competition into the equation. TAVR is an expensive treatment, and a large part of the cost is the device itself. The Centers for Medicare & Medicaid Services and other payers are watching if and how the cost-benefit seesaw swings over time.
And so are hospital administrators. Financially, TAVR programs can strain hospitals; breaking even is still a challenge. We will see if competition helps bring down prices, but payers and providers no doubt would welcome that result.
Other manufacturers offer TAVR devices in Europe and elsewhere, with trials under way in the U.S. It is probable some of those devices will work their way through the U.S. regulatory process and become available to physicians and patients. I think now there is a better chance that there will be viable TAVR programs in place in the U.S. when that happens.
Cardiovascular Business, editor