MiRus has announced the launch of the US multicentre early feasibility study (EFS) of the Siegel 8Fr aortic transcatheter heart valve.
The first two cases were successfully performed by Pradeep K Yadav and Vinod H Thourani both of Piedmont Heart Institute (Atlanta, USA). Both patients were discharged without complications the next day.
The Siegel valve encompasses an 8Fr delivery sheath allowing less invasive procedures and broader patient access, a Nickel-free valve allowing treatment, lack of foreshortening and intrinsic commissural alignment and dry porcine pericardial leaflets with anti-calcification treatment with the valve pre-mounted on the balloon.
“Our initial experience is very positive,” commented Yadav. “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.”
The combination of low delivery system profile and excellent haemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil, the company says in a press release.
“In these first two cases, the Siegel valve performance is impressive,” stated Thourani. “8Fr system with such precise placement and low gradients and no paravalvular leak (PVL) is not a combination I ever expected in a transcatheter heart valve. A transcatheter heart valve without nickel is also much needed.”
