Boston Scientific Announces FDA Approval of LOTUS Edge Transcatheter Aortic Valve System
Boston Scientific
Medical Device Manufacturer
Marlborough, Massachusetts, USA, April 26, 2019 /PRNewswire/ -- Boston Scientific Corporation (NYSE:：BSX) today announced the LOTUS Edge transcatheter aortic valve prosthesis*Approved by the U.S. Food and Drug Administration (FDA). This transcatheter aortic valve replacement (TAVR) technology can be used via minimally invasive surgery to treat patients with severe aortic stenosis who are at high risk for surgical open-heart valve replacement.
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Executive Vice President and Global President, Boston Scientific Cardiovascular Intervention DivisionKevin Ballingerstated: “The highly anticipated LOTUS that we have launched on the marketEdge Valve, committed to providing a safe and effective therapy for patients who are not suitable for traditional surgical procedures, helping to restore proper function to their severely narrowed aortic valves. This technology is an important component of our extensive product portfolio, demonstrating our continued commitment to maintaining a leading position in the rapidly growing field of structural heart disease treatment.”
LOTUS Edge The transcatheter aortic bioprosthetic valve is the only aortic valve approved by the U.S. FDA that allows physicians to reposition and fully recapture the valve after complete deployment. It features a braided stent frame and an Adaptive Seal system, which minimizes paravalvular regurgitation or paravalvular leak (PVL) by ensuring compatibility with the patient’s native aortic valve.
Executive Vice President and Global Chief Medical Officer, Boston ScientificIan Meredith AMThe professor stated, “We are pleased to provide LOTUS to physicians in the United States and Europe.Edge Valves for the treatment of high-risk patients with severe aortic stenosis.It“enables physicians to achieve precise control over valve delivery and deployment, providing paravalvular leak control outcomes comparable to those of surgical procedures, thereby aiming for optimal therapeutic efficacy.”
LOTUS, Approved by the U.S. FDAEdge The valve adds a new member to Boston Scientific’s portfolio of structural heart disease solutions. This portfolio includes the SENTINEL Cerebral Embolic Protection System and WATCHMAN, launched in the U.S. market.TMLeft Atrial Appendage Occluder, and the ACURATE launched in the European marketneo Transcatheter Implantable Heart Valve*
Boston Scientific began a limited launch of LOTUS in the European market in March 2019.Edge Valve; the product is expected to begin limited release in the U.S. market in the coming weeks.
Learn About LOTUSEdge For more information on the valve, please visit:bostonscientific.com/LOTUSEdge.
* LOTUS EdgeTranscatheter Aortic Valve Prostheses Are Not Yet Marketed in China
*ACURATE neoTranscatheter implantable heart valves are not currently marketed or used in the United States.
About Aortic Valve Disease
The aortic valve is one of the four valves that control blood flow into and out of the heart. Aortic valve disease can lead to aortic valve dysfunction. Aortic stenosis is a process characterized by thickening and hardening of the valve, which can cause abnormal narrowing of the aortic valve orifice and reduced blood flow. Aortic stenosis is the most common valvular heart disease worldwide, with a prevalence of approximately 7% among individuals aged 65 years and older.[1]If aortic valve replacement is not performed, the average two-year survival rate from the onset of symptoms of severe aortic stenosis is 50%, and the average five-year survival rate is only 20%.[2][3]
[1] Arora S, et al. “Transcatheter Aortic Valve Replacement: Comprehensive Review and Present Status.” Tex Heart Inst J. 2017; 44(1):29-38.
[2] Ramaraj R and V.L. Sorrell. “Degenerative Aortic Stenosis.” BMJ. 2008; 336(7643):550-555.
[3] Lester, S.J. et al. CHEST 1998; 113:1109-14.
About Boston Scientific
Boston Scientific Corporation is committed to innovating for life. We are dedicated to developing innovative medical solutions that improve the lives of patients worldwide. For over three decades, Boston Scientific has been a leader in the global medical technology industry, offering a broad portfolio of high-performance medical solutions to address the urgent therapeutic needs of patients and reduce healthcare costs. For more information, please visit our corporate website:www.bostonscientific.cn
About Boston Scientific in Greater China
Boston Scientific established its China headquarters in Shanghai in 1997. Currently, it has branches and R&D centers in Beijing, Shanghai, Guangzhou, Hong Kong, and Taiwan. The company’s core business areas include interventional cardiology, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic interventions, peripheral and oncology interventions, urology and pelvic health, and respiratory products. Upholding its tradition as an innovation leader, Boston Scientific is committed to becoming the most innovative international medical technology company that best meets the needs of Chinese patients and healthcare providers by offering high-quality medical products and services for prevention, diagnosis, and treatment. For more information, please visit the company’s website:www.bostonscientific.cn
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