The MiRus Siegel ™ Valve was featured in three podium presentations at the NY Valves meeting last week. Pradeep K. Yadav MD, Piedmont Heart Institute, Atlanta and Raj R. Makkar MD, Cedars Sinai Heart Institute, Los Angeles presented patient case studies and the 30 day results of US Early Feasibility Study (EFS).
In the US EFS, 15 patients with severe, symptomatic aortic stenosis (AS) were treated at Piedmont, Cedars Sinai, Stanford, Mayo Clinic and Naples. At 30 days, there were no deaths, strokes or re-hospitalizations. No patients had vascular complications, PVL (> moderate) or required a permanent pacemaker. Core lab echocardiographic data demonstrated a mean gradient of 6.3 mmHg, and valve area of 2.8 cm2 .
The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon.
“This is the first TAVR to have no foreshortening during implantation and along with small vascular access, makes it very user friendly and should also lead to fewer pacemakers and vascular complications” commented Pradeep K. Yadav, MD. “The lack of nickel is also very appealing – we were able to treat a patient with severe nickel and cobalt allergy.”
The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil.
“The gradients and valve areas with the Siegel valve are outstanding” stated Raj R. Makkar, MD. “Valve placement is very precise and allows us to protect the conduction system – one of our patients was quite elderly with pre-existing conduction system injury and we were able to replace his valve without having to place a permanent pacemaker.”
MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at www.mirusmed.com.
