Dr. Pradeep K. Yadav and Dr. Vinod H. Thourani successfully performed the first two cases with the 8-Fr aortic THV. Both patients were discharged from Piedmont Heart Institute (Atlanta) without complications the next day.
The latest development follows last year’s first-in-human data reported for Siegel out of Chile.
MiRus says its Siegel valve represents several firsts in transcatheter aortic valve replacement (TAVR). Its 8 Fr delivery sheath allows less invasive procedures and broader patient access, particularly for women. As the only nickel-free THV system, it allows for the treatment of the 20% of Americans suffering from nickel allergies.
Siegel also offers precise delivery due to a lack of foreshortening and intrinsic commissural alignment. Its dry porcine pericardial leaflets have anti-calcification treatment and it has a pre-mounted valve on the balloon.
MiRus engineered the system with its Rhenium alloys. These alloys feature unique properties that help enable the combination of a low delivery system profile and strong hemodynamics. The company says it offers high yield strength, fatigue resistance and minimal recoil.
“Our initial experience is very positive,” said Yadav. “Siegel is much less invasive than current devices and can be placed very precisely due to the lack of foreshortening. This should lead to lower pacemaker rates. The hemodynamics are excellent due to the radial strength and porcine pericardial leaflets.”
