Dive Brief:

• Medtronic Monday said it is rolling out its next-generation transcatheter aortic replacement valve (TAVR), the Evolut Pro+, in the U.S. after receiving FDA approval for the platform.
• The system aims to improve on delivery and sealing of the valve, adding a porcine pericardial tissue wrap for better interaction with native anatomy to prevent leaking.
• The launch comes a month after FDA authorized TAVR for healthier patients considered to have low risk for mortality or complications from traditional open-heart valve surgery, a decision expected to boost use of the catheter-based procedure.

Dive Insight:

U.S. approval of Medtronic’s platform is timely, with demand for the devices expected to accelerate on the heels of FDA’s low-risk expanded indication for TAVR that also stands to benefit competitor Edwards Lifesciences. Medtronic has pegged the low-risk patient pool in the United States, Western Europe and Japan at about 165,000 individuals annually.

Initially developed as a life-saving option for patients deemed too frail to withstand an open-heart procedure to repair a faulty valve, the success of the less-invasive transcatheter approach has facilitated regulatory approval for use in the intermediate-risk population and now the low-risk group.

FDA’s low-risk approval followed key studies from Medtronic and Edwards presented at the American College of Cardiology meeting earlier this year. Medtronic’s Evolut Low Risk trial demonstrated equivalence to open surgery, meeting its primary goal, while Edwards’ Partner 3 study showed the company’s Sapien device was better than surgery in preventing death, stroke and repeat hospitalization.

Both companies appear to be benefiting from their efforts to expand the TAVR market. A recent Jefferies analysis predicted a surge in use of Edwards’ valves in the third quarter, based on an early read of hospital purchasing data. Medtronic, in its August earnings presentation, reported mid-teens revenue growth in its TAVR business worldwide, in line with the overall market. “Awareness and enthusiasm around TAVR continues to build,” the company said in the presentation.

Medtronic’s latest-generation Evolut system includes four valve sizes with a pericardial tissue wrap to improve sealing and enable physicians to address more anatomical variations. The system continues use of the Evolut self-expanding nitinol frame.

Severe aortic stenosis is characterized by a stiffening of the aortic valve leaflets that forces the heart to work harder to pump blood through the body.

"As TAVR becomes a preferred treatment option for more patients with severe aortic stenosis, it's critically important to have valve technology available that keeps pace with the evolution of the therapy," Mathew Williams, heart valve program director at New York University Langone Health and paid Medtronic consultant, said in the company's announcement. 

Boston Scientific also competes in the TAVR market with the approval in April of its Lotus Edge device, but the authorization is for high-risk patients only.

In June, CMS gave the expansion of TAVR further momentum when it issued new reimbursement rules that ease barriers to entry for hospitals looking to start a program for the procedure.