News | September 17, 2013

Boston Scientific Concludes Enrollment in Pivotal Study Of Synergy Coronary Stent

Drug-eluting stent uses bioresorbable polymer to become a bare metal stent within three months

Boston Scientific Concludes Evolve II Clinical Trial Enrollment Synergy Stent

September 17, 2013 — In a significant milestone toward obtaining additional key regulatory approvals for the Synergy drug eluting stent system, Boston Scientific Corp. has completed enrollment in the EVOLVE II randomized, controlled clinical trial. The EVOLVE II trial is designed to further assess the safety and effectiveness of the Synergy stent system and support U.S. Food and Drug Administration (FDA) and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions. The Synergy stent uses the market-leading everolimus drug and features an ultra-thin directional polymer coating that is absorbed by the body shortly after drug elution ends at three months.

The EVOLVE II trial began in November 2012 and has now completed enrollment of 1,684 patients at 125 sites worldwide, including the U.S., Canada, Europe, Australia, New Zealand, Japan and Singapore. Boston Scientific received CE mark approval for the Synergy Stent System in October 2012. 

The EVOLVE II clinical trial builds upon the EVOLVE study, which was a prospective, randomized, single-blind, first-in-human use study comparing the Synergy stent system to the PROMUS Element stent system, which uses a durable polymer coating. Two-year outcomes with the Synergy stent in EVOLVE were presented earlier this year at the EuroPCR Scientific Program in Paris and showed low rates of target lesion revascularization (1.1 percent) and no stent thrombosis with the Synergy stent throughout two years.

Patients enrolled in the EVOLVE II trial will be followed for five years. The Synergy stent system is an investigational device in non-CE mark countries and is not available for sale in the United States and Japan.

For more information: www.bostonscientific.com

Related Content

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...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
Overlay Init