Abbott has reported one-year results from a real-world study (PORTICO I) of its Portico transcatheter aortic valve replacement (TAVR) system in symptomatic, severe aortic stenosis patients.
Data showed the Portico system to be safe at one year after implantation. The device was also found to result in low rates of stroke, death and leaks between patients’ natural heart tissue and itself.
It is also reported to have improved heart failure symptoms, quality of life and functional capacity.
Portico valve is being developed as a minimally invasive alternative to surgical aortic valve replacement for patients who are at high risk for open-heart surgery. The device is self-expanding, repositionable and retrievable.
The international, multi-centre PORTICO I study has been designed to assess the long-term effects of Portico valve in 941 patients treated between 2013 and 2017 at 61 sites in 14 countries across Europe, Australia and Canada.
The trial’s primary endpoint is all-cause mortality at one year, while its secondary endpoints include device performance, functional capacity improvement and adverse event rates at 30 days, one year, and annually thereafter for five years.
Abbott structural heart business chief medical officer Neil Moat said: “This real-world data demonstrates that Portico is safe and performs as intended to help patients suffering from severe aortic stenosis.
“Portico reduces the need for open-heart surgery to replace an aortic valve, and is an important part of Abbott’s mission to provide life-changing technologies to treat people with structural heart diseases.”
The company also reported positive results from a randomised, controlled COAPT trial of MitraClip device in certain patients with secondary (functional) mitral regurgitation caused due to advanced heart failure.
COAPT met the primary safety and efficacy endpoints and all secondary endpoints.
Findings also revealed that MitraClip plus medical therapy was better at decreasing rates of heart failure hospitalisations and improving survival at two years, compared to medical therapy alone.