Abbott has joined Medtronic and Edwards Lifesciences in the market for transcatheter aortic valve replacements, known as TAVR procedures, with an FDA green light allowing its Portico implant to be sold on U.S. shores.
Previously available in Europe under a CE mark, the self-expanding Portico valve and its minimally invasive FlexNav delivery system are designed for patients with severely narrowed aortic heart valves and used in cases where open-heart surgery may be too risky.
The FDA’s approval closes a gap in Abbott’s structural heart portfolio, which includes treatments like the MitraClip implant for mitral valve regurgitation and the Amplatzer Amulet for mitigating stroke risk due to atrial fibrillation.
Originally picked up in Abbott’s 2017 acquisition of St. Jude Medical, Portico will go up against Medtronic’s Evolut TAVR valve and Edwards’ Sapien 3—the two largest players left standing since Boston Scientific decided to terminate its Lotus Edge program late last year, which was aimed to allow physicians to recapture and reposition the valve if needed—following a global recall and difficulties with its delivery system.
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The Lotus program alone was expected to bring in about $250 million in revenue over 2021, analysts said at the time, amid a quickly growing field. Boston Scientific is currently developing its Acurate Neo valve for the U.S. market.
This past summer saw a sharp rebound in TAVR procedures following the first waves of the COVID-19 pandemic, with Edwards seeing year-over-year growth of about two-thirds in the second quarter, according to analysts at Jefferies.
Meanwhile, in Europe this past May, Abbott launched a newer-generation TAVR implant, the Navitor, featuring a fabric cuff to help stop blood from leaking backward around the edges of the valve.
Both Navitor and Portico use the company’s FlexNav delivery catheter, with a slim design that allows cardiologists to thread the folded-up valve through blood vessels as small as 5 millimeters.
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At the same time, the Portico valve is built to maintain open access to the entrances of the heart’s coronary artery branches, located near the aortic valve, allowing any future cardiac procedures to be performed with fewer obstructions.