Dive Brief:

• A head-to-head comparison of transcatheter aortic valve replacement (TAVR) platforms sold by Boston Scientific and Medtronic has found the devices performed comparably against key endpoints, according to results released in JAMA.

• After two years, the mortality rate was comparable across the two arms of the clinical trial, suggesting Boston Scientific’s mechanically-expanded Lotus valve is as safe as Medtronic’s self-expanding rival.

• The findings come as Boston Scientific, which supported the study, gears up to introduce its Lotus device in Europe and the U.S. and challenge Medtronic and Edwards Lifesciences.  

Dive Insight:

Boston Scientific’s ambitions to capture a slice of the fast-growing TAVR market have been on hold since it pulled Lotus devices from Europe due to an issue with the delivery system locking mechanism. That deprived Boston Scientific of sales in Europe and pushed back its plans to enter the U.S. but it continued to generate data from a key trial that began before the setback.

At the one-year point, the trial, REPRISE III, suggested Lotus had an edge over Medtronic’s CoreValve in some areas. Most notably, Lotus performed better against a primary effectiveness endpoint that looked at all-cause mortality, disabling stroke and moderate or greater paravalvular leaks (PVL).

After two years, Lotus continued to perform better than CoreValve in some areas, including the rate of disabling stroke and PVL. All-cause mortality was comparable, though, and CoreValve bested Lotus in other areas. More than 40% of Lotus patients received a new pacemaker, compared to 26% in the CoreValve arm. That data point could become a bigger issue in the coming years.   

While high-risk patients may view the pacemaker rate as acceptable, the TAVR industry may need to persuade people less tolerant to risk to use its devices if it is to continue its rapid growth. That may not happen at the current complication rate.

“The current pacemaker rate is higher than what we consider acceptable as we move toward lower-risk patients,” the authors of the paper wrote.

Changes in implantation technique and location could reduce the pacemaker rate, at which point Boston Scientific would appear to have a device that compares favorably to CoreValve in many areas.

Boston Scientific will soon find out whether its data and positioning of Lotus as a fully repositionable and retrievable TAVR device that is less prone to PVL resonates with physicians. The device is due to return to the European market next month with a U.S. approval and rollout expected to follow soon after.

Lotus will be saddled with a label that restricts use to high-risk patients at a time when rival devices from Edwards and Medtronic are gearing up to target lower-risk patients. That will limit the market opportunity for Lotus but Boston Scientific thinks it can build momentum in high-risk patients while working to generate the data it needs to expand into healthier people.   

Boston Scientific’s rivals are moving fast, though. The version of CoreValve used in the REPRISE III trial has been superseded by a device that may be less prone to PVL, and both Medtronic and Edwards are racing to claim the market.