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Mitralign Commences Early Feasibility Study for Trialign System for Tricuspid Valve Repair

December 3, 2015—Mitralign Inc. announced that the first patient in the United States has been enrolled in the SCOUT early feasibility study using the company’s Trialign system for percutaneous tricuspid valve annuloplasty.

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.

Tioga’s Luna TMVR System Used in FIH Procedures

October 23, 2024—Tioga Cardiovascular, Inc., a Shifamed portfolio company, announced the first-in-human (FIH) transseptal implantations using the company’s 28-F Luna transcatheter mitral valve replacement (TMVR) system.

Supira Medical’s Next-Generation pVAD System Used in FIH Procedures

September 16, 2022—Supira Medical, Inc., a Shifamed portfolio company focused on developing a next-generation solution for mechanical circulatory support, announced it has initiated its first-in-human (FIH) clinical study of Supira’s low-profile, high-flow percutaneous ventricular assist device (pVAD).

BioTrace Medical's Tempo Temporary Pacing Lead Introduced in the United States

December 19, 2016—BioTrace Medical Inc. announced the first commercial use of the company’s Tempo temporary pacing lead, which received US Food and Drug Administration 510(k) clearance in October.

FDA Clears BioTrace Medical's Temporary Pacing Technology for TAVR Procedures

October 27, 2016—BioTrace Medical, Inc. announced US Food and Drug Administration 510(k) clearance for the company’s Tempo Lead, a temporary pacing lead designed for use in procedures in which temporary pacing is indicated, including transcatheter aortic valve replacement (TAVR) and electrophysiology procedures.

Thubrikar’s Optimum TAV Device Evaluated at 30 Days in TAVI-1 Study to Enable CE Mark Approval

August 2, 2022—Thubrikar Aortic Valve, Inc., announced the 30-day outcomes in the first two patients receiving transcatheter aortic valve implantation (TAVI) with the company’s Optimum TAV device in the TAVI-1 study.

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).

Thubrikar’s Optimum TAVI Device Will Be Studied to Gain CE Mark Approval

December 17, 2021—Thubrikar Aortic Valve, Inc. announced that it received approval from a Competent Authority in Poland to conduct initial patient implantations with its Optimum transcatheter aortic valve implantation (TAVI) system.

Edwards Sapien 3 TAVR System Improves 30-Day Outcomes for Major Endpoints

March 15, 2015—The American College of Cardiology (ACC) announced that data presented at the ACC’s 64th annual scientific session in San Diego, California, showed that treatment with the Sapien 3 transcatheter aortic valve replacement (TAVR) system (Edwards Lifesciences) resulted in lower death, stroke, and paravalvular leak rates than earlier-generation devices in patients at high risk for surgery and showed encouraging results in intermediate-risk patients.  The Edwards-sponsored trial, PARTNER II S3, evaluated 30-day outcomes with the Sapien 3 valve, the latest modification of the balloon-expandable system used in these procedures.

Edwards Evoque System for Severe TR Studied in Initial 6-Month Data From TRISCEND II

October 26, 2023—Edwards Lifesciences announced successful results from TRISCEND II, a randomized controlled pivotal trial designed to evaluate the safety and effectiveness of the company’s Evoque tricuspid valve replacement system with optimal medical therapy (OMT) compared to OMT alone with 2:1 randomization.

Edwards Evoque Valve for Tricuspid Regurgitation Evaluated at 6 Months in TRISCEND

November 6, 2021—Edwards Lifesciences Corporation announced that results from the TRISCEND clinical trial of the company's investigational Evoque transcatheter tricuspid valve replacement system demonstrated that favorable outcomes were sustained at 6 months in the treatment of patients with tricuspid regurgitation (TR).

Edwards’ Evoque System Evaluated in TRISCEND II for Clinical and QoL Benefits in Severe TR

November 7, 2024—Edwards Lifesciences Corporation recently announced that the company’s Evoque system demonstrated superiority compared to optimal medical therapy (OMT) alone for the 1-year primary endpoint of the TRISCEND II trial in the full cohort of 400 patients.

Edwards Evoque Tricuspid Valve Replacement System Approved by FDA

February 2, 2024—Edwards Lifesciences Corporation announced FDA approval of the company’s Evoque transcatheter tricuspid valve replacement system for the treatment of tricuspid regurgitation (TR).

Edwards’ Pascal Tricuspid Valve Repair System Evaluated in CLASP TR EFS at 1 Year

April 4, 2022—The American College of Cardiology (ACC) announced 1-year follow-up findings from the Edwards CLASP TR EFS, an early feasibility study assessing the safety and performance of Edwards Lifesciences’ investigational Pascal transcatheter tricuspid valve repair system in tricuspid regurgitation.