Abbott to Enter USA TAVR Market with Portico Approval

The $6 billion high growth Transcatheter Aortic Valve Replacement (TAVR or TAVI) is dominated by two firms: Edwards Lifesciences and Medtronic.

This week, it was announced that the FDA has approved Abbott’s self-expanding Portico valve and its minimally invasive FlexNav delivery system. This allows Abbott to now market its TAVR device in the USA and compete directly with Edwards and Medtronic.

The self-expanding Portico valve and its minimally invasive delivery system (FlexNav) addresses patient needs where (i) severely narrowed aortic heart valves are a problem and (ii) open-heart surgery may be too risky for frail patients. Portico seeks to preserve open access to the entrances of the heart’s coronary arteries next to the aortic valve. Originally, Portico was a St. Jude’s technology which Abbott acquired four years ago.

This is a major add to Abbott’s structural heart product portfolio and allows the company to enter the TAVR market which is growing well into the double digits. Market drivers include the longstanding evolution in cardiovascular to less invasive interventions, opening up the opportunity for frail patients with heart valve disease to tolerate surgery and pent-up demand from deferred cases due to COVID.

Boston Scientific surprised the market when it exited the TAVR market last year, it is currently developing its device called Acurate Neo valve.  We would nonetheless expect Edwards and Medtronic, which have extensive product pipelines and R&D, to remain the dominant firms for years to come.