FDA Approves Portico with FlexNav TAVR System from Abbott

The US Food and Drug Administration (FDA) has approved the Portico with FlexNav transcatheter aortic valve replacement (TAVR) system for use in patients with symptomatic, severe aortic stenosis considered to be at high or extreme risk for open-heart surgery.

Announced in a statement from Abbott on September 20, the approval is based on results of the PORTICO IDE trial and, according to Abbott, allows the company to offer the industry’s most comprehensive portfolio of solutions to structural heart disease in the US.

"For people in the U.S. suffering from aortic stenosis and unable to have surgery, the Portico with FlexNav system offers a safe and effective treatment option," said Raj Makkar, MD, associate director of Interventional Technologies at Cedars-Sinai's Smidt Heart Institute and co-principal investigator of the PORTICO IDE trial, in the aforementioned statement.

Regarded as one of the most significant advances in cardiology in recent decades, TAVR provides patients with aortic stenosis with a less invasive alternative to surgical aortic valve replacement. According to Abbott, Portico is a self-expanding TAVR valve with intra-annular leaflets and is designed to be implanted with the FlexNav delivery system.

The PORTICO IDE trial was designed as a prospective multicenter, noninferiority, randomized controlled trial enrolling patients from 52 medical centers in the US and Australia and randomizing them in a 1:1 ratio to TAVR with the first-generation Portico valve and delivery system or another commercially available valve. The trial randomized 750 patients who were aged 21 years or older, in New York Heart Association (NYHA) functional class II or higher, and had severe native aortic stenosis. The study arms included 381 randomized to the Portico valve and 369 to commercially available valves.

The primary safety end point of the trial was a composite of all-cause mortality, stroke, bleeds requiring transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days. The primary efficacy end point was all-cause mortality or dialing stroke at 1 year. Investigators followed patients to assess clinical outcomes and valve performance up to 2 years following the procedure.

Upon analysis, results of the trial indicated the event rate was higher with the Portico valve than in the commercial valve group at 30 days (13.8% vs 9.6%; absolute difference: 4.2 [95% CI, −0.4 to 8.8]; UCB, 8·1%; P for non-inferiority=.034, P for superiority=.071). For the primary efficacy end point, results suggested rates were similar between the study arms with an event occurring among 14.8% in the Portico arm and 13.4% in the commercial valve arm (difference: 1.5% [95% CI, −3.6 to 6.5]; UCB, 5.7%; P for noninferiority=.0058, P for superiority=.50). When assessing outcomes at 2 years, rates of death (22.3% vs 20.2%; P=.40) or disabling stroke (3.1% vs 5.0%; P=.23) were similar between the Portico and commercial valve arms.

"With the approval of our TAVR therapy in the US, physicians now have access to an even more robust set of solutions to treat structural heart disease," said Michael Dale, senior vice president of Abbott's structural heart business. "This latest and important introduction of Portico with FlexNav represents another milestone in our work to advance our mission to restore health and improve quality of life so more people can get back to living fuller lives."