Biotech and Pharma

FDA approves new version of Medtronic's heart valve device

Reuters with
Excited about new product: Medtronic CEO

Medtronic said on Tuesday that the Food and Drug Administration had approved a new version of its noninvasive heart valve replacement device, making it the first recapturable and repositionable device available in the United States.

"It's an upgrade to our existing core valve product," Medtronic chief Omar Ishrak told CNBC.

Evolut-R is used to treat a condition where the aortic valve narrows, cutting off blood supply, and works by threading a new heart valve into place through an artery, eliminating the need for open heart surgery.

The device has a smaller delivery system than the previous version, which means it can be used to treat patients with smaller vessels, Medtronic said in a statement on Tuesday.

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Another feature of the device is that a doctor can recapture or redeploy the device, if required, during a procedure, the company said.

"This feature can avoid the costly error of deploying a second device and reduces complications from mal-positioned devices," Evercore ISI analysts wrote in a note.

Medtronic Chairman and Chief Executive Omar Ishrak.

Evolut-R, launched in the United States on Tuesday, was approved by European health regulators in February.

Medtronic's shares were down 0.6 percent at $76.77 in late morning trading on the New York Stock Exchange.

With the acquisition of Covidien in early 2015, Medtronic is still in the integration process.

"We look at integration from a perspective of how people are feeling about the new company," said Ishrak. "And we've done a lot of surveys and people from both legacy, Medtronic and teams are aligned with the mission of Medtronic."

Ishrak, who is attending the Piper Jaffray Heartland Summit in Minneapolis, also discussed value-based health care, or how to create a system that will hold stakeholders accountable for delivering value.

He said no one is responsible for delivering as value is dissociated with costs, especially in the U.S. Value is often realized later down the road.

"When the cost is incurred, value is not realized at the same time, but often later as the treatment happens and the person gets better later," said Ishrak.

Ishrak said that a starting point would be to define value in quantitative terms, which hasn't been done.

—CNBC's Nana Sidibe contributed to this report.