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Analysis of PARTNER Focuses on Timing, Risk Factors, and Outcomes of TIA and Stroke After TAVR

September 13, 2016—Samir Kapadia, MD, et al published findings from a comprehensive analysis of time-related incidence, risk factors, and outcomes of stroke and transient ischemic attack (TIA) after transcatheter aortic valve replacement (TAVR) in the PARTNER trial, the pivotal study of the Sapien device (Edwards Lifesciences).

Five-Year PARTNER Data Continue to Support Edwards Sapien TAVR Device

September 13, 2014—Five-year data from the PARTNER I clinical trial were presented at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

NaviGate's Transcatheter Tricuspid Valved Stent Successfully Implanted in a Compassionate-Use Procedure

May 5, 2017—NaviGate Cardiac Structures Inc. (NCSI) recently announced the first successful implantation of the company's Gate catheter-guided tricuspid atrioventricular valved stent.

Boston Scientific’s Watchman FLX Device for LAAC Evaluated at 1 Year in SURPASS Analysis

February 27, 2023—Boston Scientific announced the presentation of 1-year real-world outcomes with the company’s Watchman FLX left atrial appendage closure device in the SURPASS study of 66,894 patients with nonvalvular atrial fibrillation within the National Cardiovascular Data Registry Left Atrial Appendage Occlusion registry.

P+F’s TricValve System Granted FDA Breakthrough Device Designation

December 22, 2020—P+F Products + Features GmbH announced that FDA has granted Breakthrough Device designation for the company’s TricValve transcatheter bicaval valves system.

Mitria’s Subvalvular Spacer for Mitral Valve Repair Implanted in First Compassionate-Use Case 

March 6, 2026—Mitria Medical announced the first implantation of its subvalvular spacer (SVS) in the United States in a compassionate-use procedure under the FDA’s Single-Patient Expanded Access Program.

Pivotal Trial Begins for Cardiac Dimensions' Carillon Mitral Contour System

September 19, 2018—Cardiac Dimensions, Inc. announced that the first patient has been randomized in the CARILLON pivotal trial, which is evaluating the company's Carillon mitral contour system for the treatment of functional mitral regurgitation (FMR) associated with heart failure (HF) as compared to a randomized control group treated with optimal medical management according to established HF guidelines.

Claret Medical's SENTINEL Pivotal Trial Evaluates Cerebral Protection During TAVR

October 6, 2014—Claret Medical, Inc. announced that the first patient has been enrolled in its SENTINEL trial in the United States.

Cardiac Dimensions’ Carillon Mitral Contour System Will Be Evaluated in EMPOWER Pivotal Trial to Treat Early Stage FMR

August 20, 2021—Cardiac Dimensions announced the launch of the EMPOWER trial, a United States pivotal trial for the company’s Carillon mitral contour system for the treatment of heart failure patients with early stage functional mitral regurgitation (FMR).

STAR Trial of TAVR With MiRus’ Siegel THV Begins Enrollment

April 9, 2026—MiRus, LLC, announced commencement of enrollment and the treatment of the first patients in the STAR trial of transcatheter aortic valve replacement with the company’s Siegel 8-F transcatheter heart valve (THV).

IDE Approved for Pivotal Study of Cardiac Dimensions' Carillon Mitral Contour System

December 1, 2016—Cardiac Dimensions announced US Food and Drug Administration (FDA) approval of its application for an investigational device exemption (IDE) for its pivotal CARILLON trial.

Boston Scientific’s Watchman FLX Device Assessed in SURPASS Analysis of Real-World Outcomes

February 28, 2022—Boston Scientific Corporation announced the presentation of results from a new analysis assessing real-world outcomes with the company’s Watchman FLX left atrial appendage closure device.

Study Supports Claret Medical's Sentinel Cerebral Protection System for TAVR

September 18, 2017—Claret Medical announced findings demonstrating the role of the company's Sentinel cerebral protection system (CPS) in significantly reducing the early occurrence of stroke associated with transcatheter aortic valve replacement (TAVR).