Medtronic PLC scored a win in Europe on Monday with the announcement of wider availability for a revolutionary type of replacement heart valve that can be implanted without open-heart surgery.
Medtronic is also working closely with U.S. regulators to bring the device — called the CoreValve Evolut R System — to the same expanded group of aortic stenosis patients in the United States. Such an expansion could be worth $400 million a year in U.S. sales of the nonsurgical valves by 2020, according to one estimate.
Medtronic doesn't break out discrete sales of its transcatheter valves on financial statements, but company executives have said the fast-growing market segment represents the largest single sales opportunity in their massive cardiac and vascular group.
Open-heart surgery has long been required to replace a narrowed aortic valve, but in recent years Medtronic and Edwards Lifesciences of California have sold tens of thousands of devices that are essentially heart valves sewn inside expandable metal stents. These "transcatheter" valves are advanced into the heart via a narrow tube that is inserted in a blood vessel and then unfurled at the valve site using motion X-rays.
Transcatheter valves are higher-priced than traditional versions, but they require less patient recovery time.
Since traditional valve-replacement surgery has high success rates, the new transcatheter valves were first made available only to the patients at extremely high risks for problems, who tended to be sicker and older. With safety in those patients established, the industry has been working to get approvals for lower-risk groups.
Monday's news "marks an important milestone for the industry as we look to safely expand TAVI access to younger and less-sick patient populations," said Dr. Eberhard Grube, a doctor in Bonn, Germany, who was quoted in Medtronic's news release. (TAVI stands for "transcatheter aortic valve implantation.")
The CoreValve Evolut R was approved by the FDA for high- and extreme-risk patient groups last year.
