Dive Brief:

• FDA has approved Abbott's Portico transcatheter aortic valve replacement system, setting the company up to challenge Edwards Lifesciences and Medtronic for a major market.
• Abbott secured the approval after showing Portico was non-inferior to Edwards' Sapien and Medtronic's CoreValve against the primary safety and effectiveness endpoints. However, the study linked Portico to a higher rate of moderate or severe paravalvular leak.
• The challenge for Abbott as the newcomer is to try take share in a relatively mature market already dominated by well-set incumbents without evidence of superiority. Portico has had a limited impact in Europe, where Edwards and Medtronic are estimated to control 80% of the market despite Abbott receiving a CE mark in 2012.

Dive Insight:

The approval ends a long wait for Portico to arrive on the U.S. market. Abbott began the pivotal trial of Portico in 2014 but a pause enforced by issues with a valve leaflet meant it took until 2019 to post one-year data from the study. As Abbott worked to gather the evidence required by FDA, Edwards and Medtronic continued to expand the approved patient populations. 

Boston Scientific's recent decision to pull out of the TAVR market left Edwards and Medtronic to fill the void. However, Abbott contends it can make a mark in the U.S., with CEO Robert Ford putting TAVR near the top of a list of opportunities open to the company.

For now, Abbott can only target a slice of the market. While Edwards and Medtronic have secured approvals in younger, healthier people, Abbott's authorization from FDA is limited to patients with symptomatic, severe aortic stenosis at high or extreme risk for open-heart surgery.

Abbott has had limited impact on the European market, although the FlexNav delivery system that is included in the U.S. approval only received a CE mark last year. The FlexNav system is designed to "accommodate different patient anatomies and small vessels" and optimize "flexibility, ease of tracking and precision of valve placement," Abbott said in a statement.    

In Europe, Abbott is now promoting FlexNav as a way to deliver Navitor, the successor of Portico. A clinical trial of the device found it is less prone to paravalvular leak than Portico, suggesting Abbott has met one of its goals for the second-generation product, but the permanent pacemaker rate was higher than in studies of other valves. Abbott only recently began a larger, global study of Navitor.