Boston Scientific Receives FDA Approval for LOTUS Edge™ Aortic Valve System
Transcatheter Aortic Valve Replacement Technology for Patients with Severe Aortic Stenosis Designed to Minimize Paravalvular Leakage, Offer Controlled Delivery and Repositionability Post Deployment
MARLBOROUGH, Mass. (April, 23, 2019) – Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the LOTUS Edge™ Aortic Valve System. Delivered via a minimally-invasive procedure, this transcatheter aortic valve replacement (TAVR) technology is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery.
“Bringing the much-anticipated LOTUS Edge valve system to market allows us to provide patients who aren't good candidates for traditional surgery a safe and effective treatment alternative to restore proper function to their severely narrowed aortic valve,” said Kevin Ballinger, executive vice president and global president, Interventional Cardiology, Boston Scientific. “This technology is a fundamental component of our expanding portfolio and demonstrates our continuing commitment to category leadership within the fast-growing Structural Heart treatment landscape.”
The LOTUS Edge valve system is the only FDA-approved aortic valve that gives physicians the option to reposition and completely recapture the valve once it has been fully deployed. It also features a braided valve frame and an adaptive seal that minimizes paravalvular regurgitation or leaking (PVL) by conforming to the patient’s native aortic valve.
“We are thrilled to offer physicians in the U.S. and Europe the clinical benefits of the LOTUS Edge valve system for the treatment of their high-risk patients with severe aortic stenosis,” said Professor Ian Meredith, AM, executive vice president and global chief medical officer, Boston Scientific. “This system provides physicians a high level of control over the delivery and deployment of the device and offers surgical-like PVL results to help ensure the best patient outcomes.”
The FDA approval of the LOTUS Edge valve system adds to the Boston Scientific suite of Structural Heart product solutions – including the SENTINEL™ Cerebral Protection System and the WATCHMAN™ Left Atrial Appendage Closure Device – available in the U.S., as well as the ACURATE neo™ Aortic Valve System* in Europe.
The company commenced a controlled launch of the valve system in Europe in March and expects to begin a controlled launch in the U.S. in the coming weeks.
For more information about the LOTUS Edge valve system, visit bostonscientific.com/LOTUSEdge.
About Aortic Valve Disease
Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart. Aortic valve stenosis is the process of thickening and stiffening in the valve, which can result in an abnormal narrowing of the aortic valve opening and reduction in blood flow. Aortic stenosis is the most common valvular heart disease in the world, affecting approximately 7 percent of the population over age 65.1 From the onset of severe aortic stenosis symptoms, the average survival rate is 50 percent at two years and 20 percent at five years without aortic valve replacement.2,3
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
*The ACURATE neo™ valve system is not available for use or sale in the US.
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1Arora S, et al. “Transcatheter Aortic Valve Replacement: Comprehensive Review and Present Status.” Tex Heart Inst J. 2017; 44(1):29-38.
2Ramaraj R and V.L. Sorrell. “Degenerative Aortic Stenosis.” BMJ. 2008; 336(7643):550-555.
3Lester, S.J. et al. CHEST 1998; 113:1109-14.