FDA Approves Portico TAVI Valve, Paving the Way for Third US Device
The self-expanding system joins the FDA-cleared CoreValve and Sapien, but with an indication restricted, for now, to high-risk patients.
The US Food and Drug Administration has once again approved a third transcatheter aortic valve for the US market, giving the green light to the self-expanding Portico with FlexNav TAVI system for the treatment of symptomatic, severe aortic stenosis in patients who are at high or extreme risk for surgery, the manufacturer, Abbott, announced Monday.
“For people in the US 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 (Cedars-Sinai, Los Angeles, CA), co-principal investigator (PI) for the PORTICO IDE study, in a press release.
The other trial co-PI, Gregory Fontana, MD (Los Robles Regional Medical Center, CA), presented the results of that prospective, open-label trial back at TCT 2019 showing that the Portico valve was noninferior to other commercially available iterations of already approved devices made by Medtronic and Edwards Lifesciences.
As Fontana reported at that time, the primary safety endpoint (all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications at 30 days), occurred at a rate of 13.8% with the newer device versus 9.6% with the commercially available valves (P for noninferiority = 0.03). For the primary effectiveness endpoint (all-cause mortality or disabling stroke at 1 year), Portico also performed well compared with the other TAVI devices; rates were 14.9% and 13.4%, respectively (P for noninferiority = 0.006).
Additional data on the device was released at London Valves the same year. In the single-arm PORTICO I trial, rates of all-cause mortality, cardiovascular mortality, and disabling stroke at 2 years were 19.7%, 9.6%, and 3.1%, respectively. The rate of new pacemaker implantation was 22.3%; although high, this was nearly identical to the rate observed at 1 year. Moderate or severe paravalvular leak at 2 years in this study was 1.5%—far lower than the 7.8% seen at 1 year in PORTICO IDE, drawing some skepticism at the time.
The Portico system joins the CoreValve/Evolut family of self-expanding devices (Medtronic) and the Sapien balloon-expandable valves (Edwards Lifesciences). Late last year, Boston Scientific announced that it would be pulling its Lotus Edge device from international markets—having received FDA approval in 2019—because of design and delivery challenges that had led to multiple recalls. The company has said it is focusing instead on its Acurate neo2 device, a second-generation, self-expanding transcatheter valve system.