CMS Proposes to Expand Coverage for Transcatheter Edge-to-Edge Repair for Functional MR
June 30, 2020—The Centers for Medicare & Medicaid Services (CMS) announced the proposed update for its national coverage policy for the transcatheter edge-to-edge repair (TEER) procedure of the mitral valve to include patients with functional mitral regurgitation (MR).
Abbott Announces New Data for its Structural Heart Device Portfolio
June 25, 2020—Abbott announced the presentation of late-breaking data at the virtual PCR e-Course held online June 25 to 27, including studies of its transcatheter devices for the treatment of mitral regurgitation (MR) and tricuspid regurgitation (TR).
Medtronic Evolut TAVR System Receives Approval for Low-Risk Indication in Europe
June 22, 2020—Medtronic announced CE Mark approval and the European launch of the Evolut system for transcatheter aortic valve replacement (TAVR) in patients with severe native aortic stenosis who are at a low risk of surgical mortality.
Early Results Published From Real-World Experience With Pascal System for Transcatheter Edge-to-Edge Mitral Valve Repair
June 11, 2020—Online in EuroIntervention, Christian Besler, MD, et al published early results from a real-world series evaluating transcatheter edge-to-edge mitral valve repair with the Pascal system (Edwards Lifesciences).
Studies Published on Clinical Use of Saranas Early Bird Bleed Monitoring System
June 10, 2020—Saranas, Inc. announced the online publication of two studies in Journal of Invasive Cardiology demonstrating the accuracy and performance of the company’s Early Bird bleed monitoring system for the monitoring and early detection of internal bleed complications during endovascular procedures.
Edwards Sapien 3 Transcatheter Heart Valve Approved in China
June 8, 2020—Edwards Lifesciences Corporation announced that it has received regulatory approval from China's National Medical Products Administration for the Sapien 3 transcatheter heart valve for the treatment of patients with severe, symptomatic aortic stenosis (AS) at high risk for or unable to undergo open-heart surgery.
Study Reports on Trends and Outcomes of TAVR in Patients With Cardiogenic Shock
June 5, 2020—In Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Luke Masha, MD, et al published findings on the trends and outcomes in patients in the United States undergoing transcatheter aortic valve replacement (TAVR) who present preprocedurally with cardiogenic shock (2020;13:1314-1325).
SMT Enters Structural Heart Market With Acquisition of Vascular Concepts
May 28, 2020—Sahajanand Medical Technologies Pvt Ltd (SMT), a global medical device company based in India, announced its entry into the structural heart segment with the acquisition of Vascular Concepts, which is also headquartered in India.
TAVR Shown to Be Safe to Treat Bicuspid Valve Disease
May 27, 2020—The American College of Cardiology (ACC) announced the publication of a study demonstrating that transcatheter aortic valve replacement (TAVR) appears to be a safe treatment option with low complication rates for many patients with a bicuspid aortic valve that needs replacing.
Bleeding Risk and Frailty Evaluated in Older Adults Undergoing Aortic Valve Replacement
May 11, 2020—Frailty is associated with postprocedural major bleeding in older adults undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), which is in turn associated with a higher risk for midterm mortality, according to findings from the FRAILTY-AVR study published by Melissa Bendayan, MS, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2020;13:1058–68).
Venus Medtech Partners With Opus Medical Therapies to Develop Transcatheter Valve Technology for the Greater China Market
May 2, 2020— Venus Medtech (Hangzhou) Inc., a Chinese transcatheter heart valve company, and Opus Medical Therapies, LLC, an Atlanta, Georgia–based medical device company focused on developing transcatheter mitral valve replacement (TMVR) and transcatheter tricuspid valve replacement (TTVR) products, announced a partnership agreement to develop, manufacture, and sell these TMVR and TTVR devices in Greater China.
Registry Investigates Repeat TAVR Procedures for Transcatheter Prosthesis Dysfunction
April 27, 2020—In Journal of the American College of Cardiology (JACC), Uri Landes, MD, et al published findings from the Redo-TAVR registry, which is studying outcomes of repeat transcatheter aortic valve replacement (TAVR) for transcatheter prosthesis dysfunction (2020;75:1882–1893).
Financing Will Support Clinical Trials for Pi-Cardia’s Leaflex Aortic Valve Technology
April 20, 2020—Pi-Cardia Ltd., an Israel-based developer of nonimplant catheter-based solutions for treating heart valve calcification, announced it has closed a $27 million round of financing that will support clinical investigations of the company’s Leaflex catheter.
One-Year Echocardiographic Results From the PARTNER 3 Trial Published
April 10, 2020—Online in Circulation, Philippe Pibarot, DVM, et al published echocardiographic results from the PARTNER 3 trial of transcatheter aortic valve replacement (TAVR) using the balloon-expandable Sapien 3 valve (Edwards Lifesciences).
Abbott's TriClip Receives CE Mark Approval for Transcatheter Tricuspid Valve Repair
April 9, 2020—Abbott announced that its TriClip transcatheter tricuspid valve repair system has received European CE Mark approval as a nonsurgical treatment for tricuspid regurgitation (TR) in Europe and countries that recognize the CE Mark.
Edoxaban Compared to Warfarin After Surgical Bioprosthetic Valve Implantation or Valve Repair
March 30, 2020—Geu-Ru Hong, MD, and colleagues from Yonsei University College of Medicine in Seoul, South Korea, conducted a randomized clinical trial to compare the efficacy and safety of edoxaban and warfarin in the first 3 months after surgical bioprosthetic valve implantation or valve repair.
US Device Guide
This Device Guides offers a searchable, comprehensive listing of the available interventional cardiology devices in the United States.
European Device Guide
This Device Guides offers a searchable, comprehensive listing of the available interventional cardiology devices in Europe.