FDA Approves Medtronic’s CoreValve Technology

It’s been a tough week for Medtronic Inc., but things are looking up with an important U.S. Food and Drug Administration (FDA) approval on Friday, Jan. 17.

First, the Minneapolis, Minn.-based medtech giant cancelled a significant clinical trial because the primary endpoint wasn’t met. Later in the week, the company lost a round in a protracted legal battle against Edwards Lifesciences, with a Delaware jury ruling that Medtronic willingly had infringed an Edwards patent in the development of its CoreValve technology and owed the Irvine, Calif.-based cardiovascular firm millions of dollars in damages. Medtronic plans to appeal, but Edwards wants to, via an injunction, bar Medtronic from selling CoreValve in the United States. That may be a little more difficult now.

 Timing, they say, is everything. And Friday’s FDA approval changes things more than a little bit. CoreValve had not yet been approved in the United States (though it received CE mark in 2007) and Edwards is no longer alone in the U.S. market, which it has had to itself since late-2011.

The agency approved the self-expanding transcatheter CoreValve valve replacement system for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Untreated, these patients have a risk of dying approaching 50 percent at one year, according to the company.

Notably, the FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the extreme risk study of the CoreValve U.S. pivotal trial, which the watchdog agency claims demonstrates that the CoreValve system is safe and effective with high rates of survival and low rates of stroke and valve leakage reported.

“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,” said Jeffrey J. Popma, M.D., director of Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston, Mass., and co-principal investigator of the trial. “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.”

In the U.S. trial, the CoreValve System achieved exceptional hemodynamics, or blood flow, post-implant with results similar to the gold standard, surgical valves, Medtronic reported. Additionally, valve leakage (known as paravalvular leak or PVL) rates were low and decreased over time as the self-expanding valve conformed to the shape of a patient’s annulus—an improvement that has not been reported in other major transcatheter aortic valve replacement (TAVR) studies.

The CoreValve System was developed to serve the needs of a broad range of patients. The FDA approved the entire CoreValve platform including the CoreValve Evolut 23 mm, and the CoreValve 26 mm, 29 mm and 31 mm valves.

A self-expanding nitinol frame enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement. All valve sizes are delivered via a small (18 Fr, or 6 mm) TAVR delivery system, making it possible to treat patients with difficult or small vasculature.

“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,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart business. “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.” 

For the high-risk study of the CoreValve U.S. pivotal trial, which is comparing the CoreValve System to traditional open-heart surgery, the FDA determined it will conduct a separate review of the data.