Feature | January 14, 2014

Edwards to Begin U.S. Trial of Sapien 3 Valve for Intermediate Risk Patients

Enrollment completed in trial of high-risk patients

heart valve repair clinical trial study edwards lifesciences sapien 3
January 14, 2014 — Edwards Lifesciences Corp. announced it received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a single-arm, non-randomized clinical trial of the Sapien 3 transcatheter aortic heart valve in the treatment of intermediate risk patients with severe symptomatic aortic stenosis.
 
The company also completed enrollment in its U.S. clinical trial studying the Sapien 3 valve in the treatment of high-risk or inoperable patients.
 
The Sapien 3 valve is the only transcatheter heart valve available to U.S. patients that can be delivered through a low-profile 14 French expandable sheath. It also has an outer skirt — a cuff of fabric surrounding the bottom of the frame — to provide a seal to address paravalvular leak. The Sapien 3 valve can be implanted with the transfemoral approach through an incision in the leg, as well as alternative access approaches. It is an investigational device that is not available commercially in any country; Edwards anticipates CE mark approval in the near future.
 
The U.S. trial of the Sapien 3 valve will enroll up to 1,000 patients with a Society of Thoracic Surgeons score of 4 to 8 percent, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a Sapien 3 valve.
 
"Last year, we completed enrollment in the first U.S. randomized controlled trial involving intermediate risk patients with severe aortic stenosis,” said Larry Wood, corporate vice president, transcatheter heart valves, Edwards Lifesciences. “This unique dataset of 2,000 patients receiving surgery or transcatheter valve replacement will provide a thorough baseline comparison for this new study of the Sapien 3 valve in intermediate risk patients."
 
For more information: www.edwards.com

Related Content

melody valve

Max Page and his father Buck share a pre-operation moment on morning of July 30 Melody transcatheter valve procedure at Children's Hospital Los Angeles.

News | Structural Heart| August 28, 2015
August 28, 2015 — Cardiologists from Children’s Hospital Los Angeles successfully implanted a...
News | Cath Lab| August 26, 2015
August 26, 2014 — The Cardiovascular Research Foundation (CRF) announced the late-breaking trials and first report in

Mitral regurgitation viewed under color Doppler. Image courtesy of Toshiba.

Feature | Heart Valve Repair| August 26, 2015
August 25, 2015 — Medtronic announced it entered a definitive agreement to acquire Twelve Inc., a start–up medical de
BioSig Technologies, research agreement, UCLA, Pure EP System, EP lab, ventricular tachycardia model, VT
Technology | EP Lab| August 20, 2015
BioSig Technologies announced it has signed a sponsored research agreement with the regents of the University of...
Medtronic, CoreValve Evolut R, Loyola University Medical Center, first in Illinois, SURTAVI, EUS
News | Heart Valve Repair| August 19, 2015
Loyola University Medical Center is the first center in Illinois to implant the CoreValve Evolut R percutaneous aortic...
Sunshine Heart, COUNTER HF pivotal study, resumes enrollment, C-Pulse, FDA
News | Heart Failure| August 18, 2015
Sunshine Heart Inc. announced an update in late July on its COUNTER HF U.S. pivotal study for the C-Pulse Heart Assist...
Biotronik, BioCONTINUE study, CRT-D, defibrillator, cardiac resynchronization therapy device, heart failure, first replacement
News | Cardiac Resynchronization Therapy Devices (CRT)| August 17, 2015
Biotronik announced that the first patient has been enrolled in the BioCONTINUE clinical trial (BIOtronik study to...
Medtronic, Endurant Evo AAA, stent graft system, first European cases
News | Stent Grafts| August 13, 2015
Medtronic plc announced that the first two European patient cases with the Endurant Evo AAA stent graft system were...
zebrafish, iWorx Systems Inc., ZS-200 Zebrafish ECG System, cardiac research
Technology | ECG| August 13, 2015
iWorx Systems Inc., developer of advanced physiology teaching and research instruments and software, has introduced a...
HeartWare, ENDURANCE2 trial, destination therapy, HVAS, HeartWare Ventricular Assist System
News | Ventricular Assist Devices (VAD)| August 11, 2015
HeartWare International Inc. announced that enrollment in the ENDURANCE2 destination therapy clinical trial has been...
Overlay Init