MiRus has commenced a multi-centre early feasibility study in the US to evaluate the Siegel 8-Fr aortic transcatheter heart valve (THV).
The initial procedures were executed at the Piedmont Heart Institute, Atlanta. Both patients were released without complications the next day, said MiRus.
The Siegel valve incorporates an 8 French delivery sheath that facilitates less invasive procedures in transcatheter aortic valve replacement (TAVR). This design is also expected to broaden treatment accessibility, particularly for female patients.
The valve is said to be Nickel-free, thereby catering to the 20% of the American population with Nickel allergies. Its design ensures precise delivery and avoids foreshortening, while maintaining intrinsic commissural alignment.
The Siegel valve utilises dry porcine pericardial leaflets treated against calcification and comes pre-mounted on a balloon.
The combination of a low-profile delivery system with efficient haemodynamic is facilitated by Rhenium alloys developed by MiRus. These alloys offer properties such as high yield strength, fatigue resistance, and minimal recoil, drawing inspiration from NASA’s material science used in rocket engines.
Piedmont Heart Institute structural interventions director Pradeep Yadav said: “Siegel is much less invasive then current devices and can be placed very precisely due to the lack of foreshortening.
“This should lead to lower pacemaker rates. The haemodynamics are excellent due to the radial strength and porcine pericardial leaflets.”
In June 2024, MiRus unveiled first-in-human results of the Siegel valve from trials conducted at the Instituto Nacional Del Torax in Santiago, Chile. Five patients with severe symptomatic aortic stenosis received treatment.
According to the company, there were no reported cases of mortality or stroke after 30 days post-procedure. None of the patients required permanent pacemakers or faced vascular complications.
At the 30-day mark, the mean echocardiographic gradient stood at 6.7 mmHg. Four patients exhibited no peri-valvular leak (PVL), while one bicuspid patient displayed trace PVL.
MiRus operates from Marietta, Georgia, focusing on advancing life sciences through novel biomaterials and procedural solutions for spine, orthopaedic, and structural heart diseases.
