Until now, the ongoing push for transcatheter aortic valve replacement (TAVR) systems has primarily been for patients with high or intermediate risk of mortality due to surgery. But now Medtronic ($MDT) has staked a claim to using its next-gen device for this catheter-based approach in lieu of surgery for low-risk mortality patient with an FDA go-ahead for a 1,200-patient trial to treat aortic stenosis with its CoreValve Evolut R System that's slated to start this spring.
Both Medtronic and competitor Edwards Life Sciences ($EW) have data due in the next several months on intermediate-risk TAVR patients. And Edwards also is slated to start a 1,300-patient trial of its TAVR, Sapien 3, during the second quarter specifically in elderly patients who are at low risk of mortality.
"This trial comes on the heels of data showing patients who underwent TAVR with this self-expanding platform demonstrated superior survival benefit--with low and stable stroke rates--compared to SAVR (surgical aortic valve replacement) patients," said Dr. Michael Reardon, a professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center and principal investigator of the Medtronic study, in a statement.
He added, "This study is an important next step in developing robust clinical evidence to help heart teams understand the potential benefits of TAVR in a broader patient population."
The trial will enroll severe aortic stenosis patients from up to 80 sites who have less than 3% risk of mortality as determined by a heart team with one-to-one randomization of patients receiving the Evolut R System or undergoing open-heart surgery, or surgical aortic valve replacement (SAVR).
The primary endpoint is all-cause mortality or disabling stroke. The adaptive trial has a two-year endpoint, but it allows for a one-year analysis that could provide the basis for early FDA submission. The trial will include a sub-study of leaflet mobility in 400 patients.
The Evolut R system is intended to increase conformability and sealing at the annulus, while also maintaining supra-annular valve positioning for improved blood flow and hemodynamic performance. The valve is delivered via the EnVeo R Delivery Catheter System. Both the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System were approved by the FDA last June for use in patients at high risk for mortality.
TAVR is a super-high growth arena for Medtronic, with CoreValve Evolut R being the star performer. Given its girth, the medical device giant is working hard to focus on these sorts of high-potential segments.
"In Heart Valve Therapies, transcatheter valves grew in the high-30s globally, including mid-50s growth in the U.S., in our first full quarter of U.S. commercial launch of the CoreValve Evolut R," summed up Medtronic CFO Gary Ellis on the company's earnings call in early December. "We estimate the global TAVR market is growing at nearly 30%.
- here is the announcement