Dive Brief:

• Medtronic said it has received the go-ahead from FDA to study its Evolut transcatheter aortic valve replacement (TAVR) device in low-risk patients who have bicuspid aortic valves. Those patients are born with two aortic valve leaflets instead of the typical three.
• Medtronic will evaluate the bicuspid patients in a separate single-arm study of its ongoing Low Risk TAVR Trial, meaning all patients enrolled in that arm will receive the Evolut valve. The bicuspid clinical trial is expected to enroll 150 patients.
• FDA also approved a revised label for Evolut that removes a precaution for bicuspid patients with aortic stenosis who are at intermediate or greater mortality risk from surgical aortic valve replacement (SAVR), the traditional approach that requires open heart surgery. The new labeling allows for additional training and education for TAVR sizing and placement in bicuspid patients, Medtronic said.

Dive Insight:

FDA's actions permitting the study of the less-invasive, catheter-based TAVR procedure in low-risk bicuspid patients and label change for intermediate or higher risk bicuspid patients are steps toward expanding the market for the Evolut valve.

Although just 1% to 2% of the population is estimated to have been born with a bicuspid aortic valve, Medtronic said one in five patients who undergo SAVR for aortic valve disease are thought to have the congenital condition.

Bicuspid aortic stenosis patients have been excluded from major TAVR clinical trials due to concerns about challenging anatomical features in these patients, according to an analysis published on the American College of Cardiology's website.

Perceptions about the risks for these patients now appear to be changing. Jeffrey Popma, director of Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston, said real-world data suggest TAVR with the Evolut valve can be suitable for many patients with bicuspid aortic valve disease. "Data from the TVT Registry has shown near-parity in certain outcomes between bicuspid and tricuspid patients using the Evolut self-expanding platform," Popma said in Medtronic's press release.

Medtronic has been enjoying strong demand for its TAVR devices. The company said in its first-quarter earnings report in August that continued adoption of the Evolut valve is driving above-market, high-teens growth in its TAVR business. Medtronic launched its CoreValve TAVR system in 2014 and the Evolut R system in 2015, with the third-generation Evolut Pro approved for extreme, high and intermediate risk patients in 2017.

Medtronic competes with Edwards Lifesciences in the U.S. TAVR market. Edwards first gained FDA approval for its Sapien valve in 2011.

Boston Scientific is working to become the third competitor in the U.S. TAVR market with its Lotus Edge valve but has faced a series of setbacks. In August, the company said it was submitting the final module of its premarket approval application for the Lotus valve to FDA.