News | January 23, 2014

Bioresorbable ReZolve2 Stent Implant Transmitted Live at TCT 2013

Reva Medical ReZolve2 Bioresorbable Scaffold Stent Clinical Trial
January 23, 2014 — An implant of the ReZolve2 bioresorbable scaffold was transmitted live via satellite at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 conference in San Francisco.
 
Reva Medical Inc. collaborated to air the procedure done at the Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil to an audience at CTC. Dr. Alexandre Abizaid, director of invasive cardiology, and study co-investigator, Dr. J. Ribamar Costa performed the implant.
 
The scaffold was implanted in a patient with a blockage of the left anterior descending artery of the heart. The lesion was approximately 80 percent blocked and had evidence of moderate calcium. The procedure was performed using a 6 French radial approach, in which the scaffold is delivered to the heart through the radial artery of the wrist.
 
"We achieved a very successful acute result from this implant,” Dr. Abizaid said. “The scaffold was easily delivered, and the procedure was aided by the complete visibility of the scaffold under X-ray and the ability to achieve the desired implant diameter with a single inflation." 
 
The ReZolve2 clinical trail involves 125 patients, including the one operated on by Dr. Abizaid. Reva will use the data to apply for CE marking in 2014. 
 
12-month data from the RESTORE pilot clinical trial between December 2011 and July 2012 were also presented at TCT. The RESTORE trial was designed to evaluate safety and performance of the first generation ReZolve sirolimus-eluting bioresorbable coronary scaffold. Imaging results of patients treated with ReZolve who remained event free after treatment demonstrated a mean in-stent late loss of 0.29 mm. When imaging results for patients who had undergone retreatment for focal in-stent restenosis the mean in-stent late loss was 0.69 mm.
 
Reva developed ReZolve2 to reduce incidence of retreatment. The second generation scaffold has an approximate 30 percent increase in radial strength. 
 
For more information: www.teamreva.com 

Related Content

Clinical trial quality data can be derived from national cardiovascular registries, which may change how trials are performed in the future.

Clinical trial quality data can be derived from national cardiovascular registries, which may change how trials are performed in the future. Getty Images

News | Cardiovascular Clinical Studies | June 24, 2021
June 24, 2021 — Data captured in American College of Cardiology (ACC)...
Heavily calcified coronary arteries seen on a CT scan of the heart. Research at the New York Institute of Technology will create blood flow modeling to show the impact of calcium in arteries as part of a project to develop treatments to remove calcium.

Heavily calcified coronary arteries seen on a CT scan of the heart. Research at the New York Institute of Technology will create blood flow modeling to show the impact of calcium in arteries as part of a project to develop treatments to remove calcium. 

News | Cardiovascular Clinical Studies | January 27, 2021
January 27, 2021 — A New York Institute of Technology research te
Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...