CoreValve Indication Expanded to Include High-Risk Patients

Shelley Wood

Disclosures

June 12, 2014

MINNEAPOLIS, MN -- The US Food and Drug Administration (FDA) has expanded the indication for the CoreValve transcatheter aortic valve (Medtronic) to include high-risk surgical patients[1]. The approval comes following the positive results of the CoreValve High-Risk cohort, release earlier this year at the American College of Cardiology 2014 Scientific Sessions.

As previously reported by heartwire , the CoreValve was noninferior to surgical aortic-valve replacement in a randomized trial of 795 patients. In data presented by Dr David H Adams (Mount Sinai Medical Center, New York, NY), the CoreValve was actually superior to surgery in the Medtronic-sponsored study, although some observers questioned the validity of the statistics supporting the superiority claim.

In the approval today, the entire CoreValve platform was approved for use in high-risk surgery patients, including the 23-mm, 26-mm, 29-mm and 31-mm size valves. All four sizes can be delivered through an 18-French catheter, which, the company press release notes, is the smallest commercially available transcatheter aortic-valve replacement (TAVR) delivery system.

The CoreValve was FDA-approved in January for use in patients too frail to undergo surgical aortic-valve replacement.

"It's rewarding that we can now offer this lifesaving therapy to patients at increased risk for surgery," Dr John Liddicoat, senior vice president for Medtronic and president of the Medtronic Structural Heart Business, said in a press release. "There is a lot of excitement among US heart teams for the CoreValve System's high-risk approval, and its unique design that leads to the clinical outcomes seen in the high-risk trial."

Medtronic has recently been bruised in a patent battle with Edwards Lifesciences, the other manufacturer of a US-approved transcatheter valve. In May, Medtronic agreed to pay more than a billion dollars over the course of resolution of the legal wrangling, which will be in place until April 2022.

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