Medtronic Heart Valve Gains FDA Clearance

Medtronic Inc. (NYSE: MDT) has announced the final follow-up results from its CoreValve® CE Pivotal Study, which looks to be good news for heart patients.

In a press release, Medtronic said the CoreValve System demonstrated excellent long-term durability at four years in patients with severe aortic stenosis who were treated with the self-expanding CoreValve System. The results were presented for the first time at the 63rd Annual Scientific Session of the American College of Cardiology.

The study also showed significant improvements in quality of life at one year, which were sustained through four years, with 74 percent of patients improving at least one New York Heart Association functional class from baseline to four years. Additionally, the rates of regurgitation and stroke remained low, with 83.0 percent of patients free from stroke at four years follow-up.

“We are very encouraged by these long-term durability results for the CoreValve System, which supplement the exceptional clinical outcomes demonstrated through the U.S. pivotal trial,” said Rhonda Robb, vice president and general manager of Catheter Based Therapies at Medtronic. “For patients needing a less invasive approach for aortic valve replacement, this therapy is showing great promise with high survival rates, low stroke rates and now reliable durability out to four years.”

Medtronic said the U.S. Food and Drug Administration will allow it to skip an advisory panel on high-risk patients for its CoreValve replacement heart valve because data from the clinical study showed the transcatheter aortic heart implant is superior to open heart surgery.

“Upon reviewing the CoreValve trial’s results for high-risk patients, the FDA has determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve system for this patient group without the need for an external expert panel,” according to the press release.

The CoreValve System was approved by the FDA in January 2014 for patients considered extreme risk for surgery. The device is not currently approved in the U.S. for use with patients at high risk. Since receiving CE Mark in 2007, the CoreValve System has been implanted in more than 50,000 patients in more than 60 countries.

The CoreValve System was designed specifically to overcome the challenges of a broad range of TAVR patients. The device has a small 18Fr profile for all valve sizes, which minimizes trauma at implant, and allows physicians to treat patients with small or calcified vasculature. Its Nitinol frame is designed to prevent unwanted leakage and optimize blood flow. In addition, the CoreValve System is available in the broadest range of sizes available, so patients who have smaller, larger or in-between sizes can be accommodated.

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