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.
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.