MiRus has launched a U.S. multi-center early feasibility study for its Siegel transcatheter heart valve (THV), following first-in-human data from Chile last year. The first two U.S. cases, performed at Piedmont Heart Institute, were successful, with both patients discharged the next day without complications.
The Siegel valve introduces several innovations in transcatheter aortic valve replacement (TAVR):
- Minimally Invasive Design: An 8 Fr delivery sheath enables broader patient access, particularly for women.
- Nickel-Free Construction: The only THV system designed for the 20% of Americans with nickel allergies.
- Precision & Performance: Features include no foreshortening, intrinsic commissural alignment, and dry porcine pericardial leaflets with anti-calcification treatment.
- Rhenium Alloy Engineering: Offers high yield strength, fatigue resistance, and minimal recoil for superior hemodynamics.
“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,” said Dr. Pradeep K. Yadav.
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