Medtronic said the U.S. Food and Drug Administration approved a new version of its non-invasive heart valve replacement device, making it the first recapturable and repositionable device available in the United States.
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.
Evolut-R, launched in the United States on Tuesday, was approved by European health regulators in February this year.
Medtronic's shares were down 0.6 percent at $76.77 in late morning trading on the New York Stock Exchange.
© 2021 Thomson/Reuters. All rights reserved.