Dr. Pradeep K. Yadav, director of structural interventions at Atlanta’s Piedmont Heart Institute, presented data at the New York Valves Conference.
Five patients with severe, symptomatic aortic stenosis (AS) received treatment at the Instituto Nacional Del Torax in Santiago, Chile. Three patients had bicuspid aortic valves and two were tri-leaflet. Three patients had peripheral arterial disease (PAD) with vascular access less than 5.5 mm.
MiRus reports no mortality or stroke at 30 days, while no patients required a permanent pacemaker or suffered vascular complications. At 30 days, investigators reported a mean echo gradient of 6.7 mmHg. Four of five patients presented no peri-valvular leak (PVL), while one bicuspid patient had trace PVL.
“The ease of use and hemodynamics were impressive” Yadav said in a news release. “On the very first case, we comfortably achieved a deployment with 90% aortic and 10% ventricular positioning. The lack of foreshortening is very helpful in precise deployment every time, a feature that implanters will love. Also the frame strength and virtually no recoil, allows cylindrical valve expansion with no waist even in complex bicuspid patients, which contributes to excellent hemodynamics and hopefully durability.”
More about the MiRus Siegel TAVR system
Siegel features an 8 Fr delivery sheath, allowing for less invasive procedures and broader patient access. This particularly applies to women, for whom multiple companies have been evaluating the impact of TAVR, including Medtronic and Edwards.
MiRus says it offers the only nickel-free TAVR system. This enables the treatment of those suffering from nickel allergies. The Cleveland Clinic says nickel allergy affects about 10% of Americans. Siegel also offers a precise delivery process with a lack of foreshortening and intrinsic commissural alignment. It has dry procine pericardial leaflets with anti-calcification treatment and the valve pre-mounted on the balloon.
According to MiRus, the unique properties of rhenium alloys within the system enable the combination of a low-profile delivery system and strong hemodynamics. The system offers high yield strength, fatigue resistance and minimal recoil.
“This initial data is striking and potentially heralds a new age for TAVR,” said Dr. Vinod H. Thourani, chair of cardiovascular surgery and the Marcus Valve Center, Piedmont Heart Institute. “The ability to treat such complex patients with an 8 Fr system and without nickel exposure should make TAVR safer and more broadly accessible. From a surgical viewpoint, the very low pressure gradients and low PVL are critically important to implanters and our patients.”
