Search Results

Early Results Presented for Edwards' Sapien M3 System to Treat Mitral Regurgitation

March 5, 2018—John Webb, MD, presented "encouraging" findings from the early experience with the Sapien M3 system (Edwards Lifesciences) for the treatment of mitral regurgitation at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.

First Clinical Case Performed With Embrella Embolic Deflector

January 4, 2010—Embrella Cardiovascular, Inc., (Wayne, PA) announced the completion of the first clinical case using the Embrella Embolic Deflector device.

Embrella Embolic Deflector Used for First Clinical Case

January 4, 2010—Embrella Cardiovascular, Inc. (Wayne, PA) announced the completion of the first clinical case using the Embrella Embolic Deflector device.

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

June 7, 2011—St.

Edwards Reports First Data for Sapien 3 Transcatheter Valve

May 20, 2014—Edwards Lifesciences announced that the first data on the Edwards Sapien 3 transcatheter aortic heart valve were presented in a late-breaking clinical trial session at EuroPCR 2014 by John Webb, MD, a principal investigator of the SAPIEN3 trial.

One-Year TAVR Outcomes Reported With Edwards SAPIEN 3 System

May 19, 2015—Edwards Lifesciences Corporation announced that results were presented for the first high-risk European patients to receive the Edwards SAPIEN 3 transcatheter aortic valve replacement (TAVR) system via transfemoral delivery.

Edwards Sapien 3 Heart Valve Approved in Canada

July 27, 2016—Edwards Lifesciences Corporation announced that Health Canada has approved the Edwards Sapien 3 transcatheter heart valve for the treatment of patients with severe, symptomatic aortic stenosis and at high or greater risk for surgical aortic valve replacement.

Neovasc Announces First-in-Human Implantation of Tiara Transcatheter Mitral Valve

February 3, 2014—Neovasc Inc. (Vancouver, BC, Canada) announced that the first-in-human implantation of the self-expanding Tiara transcatheter mitral valve was performed on January 30 at St.

Edwards' Sapien 3 Ultra TAVR System Approved in Europe

November 16, 2018—Edwards Lifesciences announced that it has received European CE Mark approval for its Sapien 3 Ultra system for transcatheter aortic valve replacement (TAVR) in patients with severe, symptomatic aortic stenosis.

Edwards Sapien 3 TAVR System Receives Expanded Approval in Canada for Low-Risk Patients

December 18, 2020—Edwards Lifesciences Corporation announced that Health Canada has approved the expanded use of the Edwards Sapien 3 and Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) systems for the transfemoral treatment of patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open heart surgery.

JC Medical TAVR System Implanted for First Time Outside China

February 25, 2016—JC Medical, Inc. announced the successful implantation of its J-Valve bioprosthesis using the Ausper transapical delivery device in a patient in Canada.

Claret Medical's Montage 2 Embolic Filter System Receives CE Mark Approval

February 27, 2013—Claret Medical, Inc. (Santa Rosa, CA) announced that the Montage 2 dual filter system received CE Mark approval.

FDA Approves Edwards' Sapien 3 Ultra TAVR System

January 4, 2019—Edwards Lifesciences announced FDA approval for its Sapien 3 Ultra system for transcatheter aortic valve replacement (TAVR) in patients with severe symptomatic aortic stenosis who are determined to be at immediate or greater risk of open heart surgery.

Claret's Sentinel Cerebral Protection System for TAVR Gains CE Mark Approval

January 27, 2014—Claret Medical, Inc. (Santa Rosa, CA) announced that it has received CE Mark approval for its Sentinel cerebral protection system (CPS) to provide embolic protection during transcatheter aortic valve replacement (TAVR). The product will be launched immediately in selected CE Mark countries.According to Claret Medical, the Sentinel CPS is a filter-based system that captures and removes embolic debris that are released and travel to the brain during TAVR procedures.

First United States Procedure Performed With JC Medical's J-Valve TF System

January 7, 2019—JC Medical announced the successful treatment of the first United States patient with the J-Valve TF (transfemoral) system, the company’s transfemoral transcatheter aortic valve replacement (TAVR) device.

Enrollment Completed in Pivotal Trial of Essential Medical's Manta Large-Bore Vascular Closure Device

October 2, 2017—Essential Medical, Inc. announced the completion of enrollment in the United States pivotal trial of its Manta large-bore vascular closure device.