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Aortic Valve Replacement System Approved for High-Risk Patients With Heart Disease
Boston Scientific Corporation has received FDA approval for the LOTUS Edge™ Aortic Valve System. Delivered via a minimally invasive procedure, the transcatheter aortic valve replacement (TAVR) technology is approved for the relief of aortic stenosis in patients with symptomatic heart disease as a result of severe native calcific aortic stenosis who are at high risk for open heart surgery.
The valve system is the only FDA-approved aortic valve that enables physicians to reposition and recapture the valve after it has been fully deployed. Also, the system’s braided valve frame and adaptive seal reduces paravalvular regurgitation or leaking (PVL) by conforming to the patient’s aortic valve.
Aortic stenosis, the world’s most common valvular heart disease, affects approximately 7% of adults over the age of 65. From the onset of severe symptoms, the average survival rate is 50% at two years and 20% at five years without aortic valve replacement.
In REPRISE III, the first head-to-head pivotal clinical trial, the LOTUS valve platform demonstrated significantly lower moderate to severe PVL, significantly lower disabling stroke rates, and superior procedural outcomes.
The Lotus Edge Valve System is contraindicated in patients with the following:
- non-calcified aortic annulus;
- active systemic infection, sepsis or endocarditis;
- known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or known hypersensitivity or contraindication to aspirin, thienopyridines, heparin, nickel, titanium, tantalum, bovine-derived materials, or polyurethanes; and
- severe arterial tortuosity or calcification that would prevent safe placement of the introducer sheath.
Boston Scientific expects to begin a controlled launch of the system in the U.S. during the coming weeks.
Source: Boston Scientific, April 23, 2019