 |
| The Sapien XT TAVR device--Courtesy of Edwards Lifesciences |
Edwards Lifesciences ($EW) received a long-expected FDA approval to begin the U.S. rollout of Sapien XT, the company's next-generation transcatheter aortic valve replacement (TAVR) device.
The valve was designed for use in the treatment of high-risk and inoperable patients suffering from severe symptomatic aortic stenosis. Sapien XT is a lower-profile system, which includes a 29 mm valve size for patients with a large native annulus that will allow for the treatment of more patients, the company said.
"This approval provides greater options for U.S. patients who can benefit from the substantial enhancements in this proven platform," Larry L. Wood, Edwards' corporate vice president of transcatheter heart valves, said in a statement.
In a small trial reported earlier this year, the Sapien XT beat out Medtronic's ($MDT) CoreValve in a head-to-head comparison of the two competing TAVR devices.
The investigator-initiated study of 241 patients at 5 German hospitals found the Sapien XT had a 95.9% success rate compared with 77.5% for Medtronic's self-expandable valve, CoreValve. The results were published in The Journal of the American Medical Association and indicated Sapien XT, the latest version of Edwards' balloon-expandable system, is more likely to be implanted correctly and prevent blood from leaking across the aortic valve.
The results were seen as a marketing coup for Edwards as the competition in what is estimated to be a $3 billion a year device segment has begun to heat up in the last few years. In addition to Medtronic, Boston Scientific ($BSX) and JenaValve have competing devices.
- read the release