Abbott’s Portico With FlexNav TAVR System Receives FDA Approval

September 20, 2021—Abbott announced that the FDA has approved the company’s Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat patients with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.

According to the company, Portico is a self-expanding TAVR valve with intra-annular leaflets that help provide optimal hemodynamics when placed inside a patient’s natural valve. The structure of the replacement valve also preserves access to the critical coronary arteries for future coronary interventions. The Portico device is implanted using Abbott’s FlexNav delivery system, which features a slim design to accommodate different patient anatomies and small vessels, and optimizes flexibility, ease of tracking, and precision of valve placement.

FDA approval was supported by PORTICO-IDE, an investigational device exemption study.

Raj Makkar, MD, and Gregory Fontana, MD, served as co-principal investigators for the PORTICO-IDE study. Dr. Makkar, who is Associate Director of Interventional Technologies at Cedars-Sinai’s Smidt Heart Institute in Los Angeles, California, commented in the company’s press release, “For people in the United States suffering from aortic stenosis and unable to have surgery, the Portico with FlexNav system offers a safe and effective treatment option.”

In September 2019, Dr. Fontana presented the PORTICO-IDE study’s 30-day safety and 1-year effectiveness outcome sat TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, held September 25-29 in San Francisco, California.