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TAVR Shown to Be Safe in Treating Patients With Bicuspid Valves

March 17, 2019—The American College of Cardiology (ACC) announced that findings from a trial studying transcatheter aortic valve replacement (TAVR) treatment of bicuspid valves in patients at intermediate or high surgical risk were presented by Lead Investigator Raj Makkar, MD, at the ACC's 68th Annual Scientific Session being held March 16–18 in New Orleans, Louisiana.

St. Jude Medical Announces First Implant of Portico Transcatheter Heart Valve

June 7, 2011—St.

CT Scans Show Reduced Leaflet Motion After TAVR in RESOLVE and SAVORY Registries

March 19, 2017—The American College of Cardiology (ACC) announced that an observational study found that approximately 12% of patients undergoing aortic valve replacement developed subclinical leaflet thrombosis that reduced the motion of the valves.

JENA-VAD Registry for JenaValve’s Trilogy THV System Enrolls First Patient

December 16, 2024—JenaValve Technology, Inc., developer of the Trilogy transcatheter heart valve (THV) system announced the completion of the first patient procedure for inclusion in the JENA-VAD registry.

JenaValve’s Trilogy THV System for Symptomatic, Severe AR Launched in the United States 

April 1, 2026—JenaValve Technology, Inc. announced the United States launch of the Trilogy transcatheter heart valve (THV) system.

PARTNER's 2-Year Inoperable Cohort Data Support Edwards Sapien Valve

November 10, 2011—Edwards Lifesciences Corporation (Irvine, CA) announced 2-year results from the PARTNER trial's cohort B, which was composed of 358 inoperable patients with severe aortic stenosis who were evenly randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Sapien transcatheter heart valve or standard therapy.

Pivotal REFLECT Study Begins for Keystone Heart's TriGuard Embolic Deflection Device

June 17, 2016—Keystone Heart Ltd. announced enrollment of the first patient in the pivotal United States REFLECT study to evaluate the safety and efficacy of the company’s TriGuard embolic deflection device.

Pi-Cardia’s ShortCut Leaflet Modification Device for TAVR Used in First Commercial Procedures

March 3, 2025—Pi-Cardia Inc., an Israel-based developer of leaflet modification solutions for treating heart valves, announced the first commercial procedures with the company’s ShortCut leaflet modification device for enabling valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction.

Recor Medical’s Paradise uRDN System Launched in United States

November 14, 2023—Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd., have announced the first commercial uses of Recor’s Paradise ultrasound renal denervation (uRDN) system for the treatment of hypertension.

JenaValve’s ARTIST RCT of Trilogy System in AR Begins Enrollment

July 17, 2025—JenaValve Technology, Inc. recently announced commencement of patient enrollment in both the transcatheter aortic valve replacement (TAVR) arm and the surgical aortic valve replacement (SAVR) arm of the ARTIST randomized controlled trial.

Abbott’s Portico With FlexNav TAVR System Receives FDA Approval

September 20, 2021—Abbott announced that the FDA has approved the company’s Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat patients with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.

Edwards’ Sapien 3 TAVR Device Evaluated for Bicuspid Aortic Stenosis in Real-World TVT Registry

May 18, 2021—Edwards Lifesciences announced the results of a real-world study comparing outcomes for patients with bicuspid aortic stenosis (AS) who were treated with the company’s Sapien 3 and Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) devices and were at low risk of death from surgery.

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).

JenaValve’s ALIGN-AR United States Pivotal Trial of Trilogy TAVR System Completes Enrollment

September 14, 2022—JenaValve Technology, Inc. announced the successful completion of patient enrollment in the ALIGN-AR pivotal trial of the company’s Trilogy transcatheter aortic valve replacement (TAVR) system.