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TAVR Compared to Surgery in Low-Risk Patients at 2 Years in PARTNER 3 Trial

March 29, 2020—Michael J. Mack, MD, presented 2-year clinical and echocardiographic outcomes from the PARTNER 3 study at the virtual conference of the American College of Cardiology’s (ACC) Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC). The PARTNER 3 trial focused on a low-risk patient population.

Three-Year COAPT Data Support Abbott's MitraClip TMVR Device

September 28, 2019—The Cardiovascular Research Foundation (CRF) announced that results from the COAPT trial were presented by coprincipal investigator Michael J. Mack, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California.

STS/ACC TVT Registry Reports on Initial Edwards Sapien TAVR Outcomes in the United States

November 17, 2013—Outcomes from the Society of Thoracic Surgeons/American College of Cardiology's Transcatheter Valve Therapy (STS/ACA TVT) Registry were presented by Michael J. Mack, MD, at the American Heart Association's Scientific Sessions 2013 in Dallas, Texas and were published by Dr. Mack et al in the Journal of the American Medical Association (JAMA; 2013;310:2069–2077).

ACC and STS Issue Expert Consensus Document on Transcatheter Valve Therapy

June 27, 2011—The American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) have published an expert consensus document on transcatheter valve therapy.

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.

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.

Multisociety Consensus Document Offers Guidance for TAVR

January 31, 2012—A multisociety expert consensus document from the American College of Cardiology Foundation (ACCF), the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS) was published to provide guidance on the use of transcatheter aortic valve replacement (TAVR) to treat patients with aortic valvular stenosis.

Edwards’ Sapien 3 TAVR System Evaluated at 5 Years in PARTNER 3 Trial

October 24, 2023—Edwards Lifesciences announced new data from the PARTNER 3 trial demonstrating continued low rates of all-cause mortality, disabling stroke, and rehospitalization at 5 years with the company’s Sapien 3 device for transcatheter aortic valve replacement (TAVR) in a low surgical-risk cohort of patients.

Edwards' Sapien 3 TAVR System Approved in Europe for Low-Risk Patients

November 6, 2019—Edwards Lifesciences announced that it has received CE Mark approval to expand use of the Sapien 3 transcatheter heart valve for the treatment of patients with aortic stenosis who are at low risk for open heart surgery.

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.

COAPT Economic Analysis Demonstrates Cost-Effectiveness of TMVR With MitraClip

September 29, 2019—The Cardiovascular Research Foundation (CRF) announced that results from a new economic analysis of the COAPT trial data were presented by Suzanne J. Baron, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California. The results were published simultaneously by Dr. Baron et al online in Circulation.

CMS Initiates National Coverage Analysis of TAVR

September 29, 2011—The US Centers for Medicare & Medicaid Services (CMS) has initiated a National Coverage Analysis (NCA) of transcatheter aortic valve replacement (TAVR). CMS stated that it received a formal national coverage determination (NCD) request from the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). According to CMS, STS and ACC advised the agency that clinical trial data shows that the most successful patient outcomes occur when the following criteria are met: the procedure is performed in a specialized heart center and managed using a multidisciplinary team in which each member has appropriate training and credentials (requirements are currently under development for this); the procedure is performed in a modified conventional cardiac laboratory or hybrid operating room that contains the specialized equipment necessary for the procedure; and the multidisciplinary team uses a planned approach to co-manage decision making as well as technical insertion of the device.

One-Year Echocardiographic Results From the PARTNER 3 Trial Published

April 10, 2020—Online in Circulation, Philippe Pibarot, DVM, et al published echocardiographic results from the PARTNER 3 trial of transcatheter aortic valve replacement (TAVR) using the balloon-expandable Sapien 3 valve (Edwards Lifesciences).

STS/ACC Launch Registry for Transcatheter Valve Therapy

December 1, 2011—The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) announced the launch of the first-of-its-kind registry to monitor the safety and efficacy of transcathether aortic valve replacement therapy (TAVR), which was approved by the US Food and Drug Administration (FDA) in November 2011 for elderly patients with aortic stenosis who are too sick, frail, or high risk for surgical therapy.

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.

Edwards Sapien 3 TAVR Device Demonstrates Cost Effectiveness in PARTNER 3 Analysis

November 5, 2021—Edwards Lifesciences announced that a cost-effectiveness analysis comparing transcatheter aortic valve replacement (TAVR) to surgery demonstrated that TAVR with Edwards’ Sapien 3 is an economically dominant treatment strategy, offering improved outcomes and reduced cost.