Medtronic has reported positive data from the Low Risk Bicuspid Study, which evaluates the use of the Evolut transcatheter aortic valve replacement (TAVR) system in patients with bicuspid aortic valve stenosis at low surgical risk.
The 150-patient single-arm study reported low rates of all-cause mortality or stroke at 30 days (1.3%) with a low rate of serious procedural complications.
It also showed a 95.3% device success rate and a low rate of serious procedural complications, including no annular ruptures or aortic dissection.
In addition, the outcomes showed a low rate of all-cause mortality and a low rate of disabling stroke.
The study co-primary investigator Basel Ramlawi said: “These findings point to potentially less invasive treatment for patients who otherwise would undergo open-heart surgery due to their anatomical valve structure.
“We feel confident that these primary early outcomes provide additional evidence that the Evolut TAVR platform is a suitable treatment option for patients with bicuspid valves who have previously been left out of TAVR trials.”
The Evolut TAVR platform includes the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems.
It is indicated for symptomatic severe aortic stenosis (AS) patients across extreme, high, intermediate and low-risk categories and for Bicuspid valve patients at intermediate risk.
AS affects 1.5 million individuals globally and is one of the most common valvular heart diseases in the world.
Bicuspid aortic valve disease (BAVD) is a congenital heart defect, affecting approximately 2% of the general population. It is an abnormality of the aortic valve, leaving the patient with two functional valve leaflets instead of the more common three leaflets (tricuspid).
Patients with BAVD were generally excluded from prior TAVR trials due to concerns of asymmetric calcification, an elliptical shape, potential incomplete valve expansion, procedural technical concerns and other risk factors.
In September 2019, Medtronics launched the Evolut PRO+ TAVR System in the US, following its approval from the Food and Drug Administration (FDA).