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ACC and CRF Create the Martin B. Leon Center for Cardiovascular Transformation

October 14, 2020—The American College of Cardiology (ACC) and the Cardiovascular Research Foundation (CRF) announced that they are partnering to create the Martin B. Leon Center for Cardiovascular Transformation to foster the best ideas, encourage innovative research, and deliver transformative solutions to some of the biggest cardiovascular care challenges.

Twelve-Month ENDEAVOR IV Outcomes Published

February 17, 2010—Twelve-month outcomes from the ENDEAVOR IV trial have been published by Martin B. Leon, MD, et al in the Journal of the American College of Cardiology (2010;55:543–554).

Medtronic's Zotarolimus-Eluting Stent Shows Improved Late Clinical Safety in ENDEAVOR IV Trial

October 20, 2010—Martin B. Leon, MD, et al have published 3-year follow-up results from the ENDEAVOR IV trial in the Journal of the American College of Cardiology: Cardiovascular Interventions (2010;3:1043–1050). ENDEAVOR IV is a randomized controlled trial comparing the Endeavor zotarolimus-eluting stent (ZES) (Medtronic, Inc., Minneapolis, MN) and the Taxus paclitaxel-eluting stent (PES) (Boston Scientific Corporation, Natick, MA) in patients with coronary artery disease.

NeoChord Nexus TMVR System’s US Early Feasibility Study to Be Led by Dr. Martin Leon

March 14, 2022—NeoChord, Inc. announced the appointment of Martin B. Leon, MD, as Executive Chair of the United States early feasibility study (EFS) of the NeoChord transcatheter Nexus system for mitral chordal repair.

Edwards' PARTNER Results Published, FDA Approves PARTNER II

September 22, 2010—Edwards Lifesciences (Irvine, CA) announced that The New England Journal of Medicine published (online ahead of print) results from Cohort B of the PARTNER trial by Martin B. Leon, MD, et al, which studied the Edwards Sapien transcatheter heart valve for the treatment of severe aortic stenosis. The results of the trial successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization. The results were also presented on September 23 at the Transcatheter Cardiovascular Therapies scientific symposium in Washington, DC.

PARTNER 3 Compares TAVR and Surgery in Low-Risk Patients With Severe Symptomatic Aortic Stenosis

March 16, 2019—The American College of Cardiology (ACC) announced that the 1-year findings from the PARTNER 3 trial will be presented on March 17 by Martin B. Leon, MD, at the ACC's 68th Annual Scientific Session, being held March 16–18 in New Orleans, Louisiana. The findings have been published online ahead of print by Michael J. Mack, MD, et al in The New England Journal of Medicine.

FDA Approves Pivotal Study of Tryton's Side Branch Stent

December 2, 2010—Tryton Medical, Inc. (Durham, NC) announced US Food and Drug Administration conditional approval for an investigational device exemption application to initiate a pivotal trial that will evaluate the company's side branch stent system for treating coronary artery disease.

CroíValve Begins TANDEM II Early Feasibility Study of Duo Tricuspid Coaptation Valve

January 25, 2024—CroíValve announced the initiation of its TANDEM II early feasibility study (EFS) for the Duo tricuspid coaptation valve system.

Pi-Cardia’s ShortCut Leaflet Modification Device for TAVR Cleared by FDA

September 30, 2024—Pi-Cardia Ltd., an Israel-based developer of leaflet modification solutions for treating heart valves, announced FDA clearance to market the company’s ShortCut in the United States.

2-Year Outcomes Published From PARTNER 3 Trial of TAVR in Low-Risk Patients

March 1, 2021—Two-year outcomes were published from the PARTNER 3 trial, which is evaluating the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the Sapien 3 device (Edwards Lifesciences) in patients with symptomatic severe aortic stenosis who are at low surgical risk.

TAVR and SAVR in Low-Risk Patients Show Comparable Outcomes in 7-Year PARTNER 3 Data

November 10, 2025—The 7-year results from the PARTNER 3 trial demonstrated no significant difference in clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) among patients at low surgical risk with severe, symptomatic aortic stenosis.

ENDEAVOR IV Safety and Efficacy Data Presented

September 21, 2009—At the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco, Medtronic, Inc. (Minneapolis, MN) announced the latest findings from the ENDEAVOR IV clinical trial, a large study comparing Medtronic's Endeavor zotarolimus-eluting stent and the Taxus paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA).

Medtronic Presents ENDEAVOR IV Safety and Efficacy Data

September 21, 2009—At the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco, Medtronic, Inc. (Minneapolis, MN) announced the latest findings from the ENDEAVOR IV clinical trial, a large study comparing Medtronic's Endeavor zotarolimus-eluting stent and the Taxus paclitaxel-eluting stent (Boston Scientific Corporation, Natick, MA).

Edwards' PARTNER Study Enrollment Marks Milestone

March 17, 2009—Edwards Lifesciences LLC (Irvine, CA) announced the completion of enrollment in the 350-patient nonsurgical study arm of the US pivotal PARTNER (Placement of Aortic Transcatheter Valves) trial for the Edwards Sapien transcatheter aortic heart valve.

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.

Analysis Supports Tryton Device in Bifurcations With Large Side Branches

September 30, 2015—Tryton Medical, Inc. announced that results of a post hoc analysis of the pivotal Tryton Randomized Clinical Trial (RCT) have been published online ahead of print by Philippe Généreux, MD, et al in Catheterization and Cardiovascular Interventions (CCI).

First United States Commercial Implantations With EluNIR DES Performed

January 11, 2018—Cordis, a Cardinal Health company, and Medinol announced that the first commercial cases using the EluNIR drug-eluting stent (DES) in the United States were performed at New York-Presbyterian Hospital/Columbia University Medical Center in New York, New York, and the Piedmont Heart Institute in Atlanta, Georgia.

VARC Definitions Evaluated for Measuring TAVR Outcomes

April 11, 2012—A weighted meta-analysis was performed to determine the rates of major outcomes after transcatheter aortic valve replacement (TAVR) using Valve Academic Research Consortium (VARC) definitions and to evaluate their current use in the literature.

Edwards' Sapien 3 TAVR Systems Receive FDA Approval for Low-Risk Patients

August 16, 2019—Edwards Lifesciences announced FDA approval to expand use of the company's Sapien 3 and Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) systems to the treatment of severe, symptomatic aortic stenosis patients who are determined to be at low risk of open heart surgery.