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Analysis Published of Embolic Debris Captured During TAVR Using Claret Medical's Montage 2 System

May 20, 2013—Claret Medical, Inc. (Santa Rosa, CA) announced that Nicolas M. Van Mieghem, MD, et al published a study on the histopathology of embolic debris captured during transcatheter aortic valve replacement (TAVR) using the company's Montage 2 dual-filter embolic protection system. The study is available online ahead of print in Circulation.

Boston Scientific's Lotus TAVR System Demonstrates Low PVL Rates

May 20, 2015—Boston Scientific Corporation announced that a study evaluating the company’s Lotus transcatheter aortic valve replacement (TAVR) system demonstrated an extremely low rate of paravalvular aortic leak (PVL) plus a cardiovascular mortality rate of < 2% at 30 days. 

CE Mark Approval Data Published for Essential Medical's Manta Large-Bore Vascular Closure Device

April 3, 2017—Essential Medical, Inc. announced the publication of the CE Mark approval study of the Manta vascular closure device, "Percutaneous Plug-Based Arteriotomy Closure Device for Large-Bore Access" by Nicolas M. Van Mieghem, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions.

TAVR UNLOAD Shows Limited Benefit of TAVR in Patients With HFrEF and Moderate AS

October 28, 2024—Findings from the TAVR UNLOAD study found limited benefits of transcatheter aortic valve replacement (TAVR) in the treatment of heart failure with reduced ejection fraction (HFrEF) and moderate aortic stenosis (AS).

Teleflex Acquires Essential Medical

October 4, 2018—Teleflex announced that it has acquired Essential Medical, Inc., a privately held company based in Exton, Pennsylvania, that developed and commercialized the Manta vascular closure device.

ENVISAGE-TAVI AF Compares Edoxaban Versus Vitamin K Antagonists After Valve Replacement in Patients With AF

August 28, 2021—The European Society of Cardiology (ESC) announced findings from the ENVISAGE-TAVI AF trial, which compared the safety and efficacy of the direct-acting oral anticoagulant (DOAC) edoxaban with vitamin K antagonists (VKAs; warfarin and its analogs) in patient with atrial fibrillation (AF) and an indication for oral anticoagulation after successful transcatheter aortic valve replacement (TAVR).

Medtronic's CoreValve Evolut Pro TAVR Device Approved in Europe

July 31, 2017—Medtronic announced CE Mark approval and the European launch of the CoreValve Evolut Pro valve for transcatheter aortic valve replacement (TAVR) treatment of severe aortic stenosis in symptomatic patients who are at intermediate, high, or extreme risk for open heart surgery.

SURTAVI Post Hoc Analysis Compares TAVR and SAVR Outcomes in Men Versus Women

November 24, 2020—Findings from a post hoc analysis of the randomized SURTAVI trial evaluated clinical outcomes of transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in men and women with aortic stenosis at intermediate operative risk.

Claret Medical Seeks FDA Clearance of Sentinel Cerebral Protection System for TAVR

September 20, 2016—Claret Medical, Inc. announced the filing of a marketing application with the US Food and Drug Administration (FDA) for clearance of its Sentinel cerebral protection system (CPS) for use during transcatheter aortic valve replacement (TAVR).

Boston Scientific's Lotus TAVR System Receives CE Mark Approval

October 28, 2013—Boston Scientific Corporation (Natick, MA) announced European CE Mark approval for the Lotus valve system for transcatheter aortic valve replacement (TAVR) as a treatment alternative for patients with severe aortic stenosis at high risk for surgical valve replacement.

5-Year SURTAVI Data Compare Outcomes for TAVR Versus Surgery in Intermediate-Risk Patients

November 5, 2021—New 5-year data from the SURTAVI trial found that there was no difference in all-cause mortality or stroke between patients at intermediate surgical risk who had transcatheter aortic valve replacement (TAVR) or surgery.