News | September 18, 2009

Boston Scientific Completes Enrollment in Pivotal Trial for New Everolimus Stent

September 18, 2009 – Boston Scientific today said it completed patient enrollment in the workhorse portion of its PLATINUM clinical program, a global, randomized, pivotal controlled trial designed to support FDA and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the platinum-chromium PROMUS Element Everolimus-Eluting Coronary Stent System.

The trial enrolled 1,532 patients with up to two de novo lesions at more than 140 sites worldwide, and completed enrollment two months ahead of schedule.

The PLATINUM workhorse trial evaluates the new PROMUS Element in comparison with the current PROMUS stent, which uses the same drug dose and polymer on an earlier cobalt-chromium alloy stent design. Two parallel subtrials will evaluate the PROMUS Element in small vessels and long lesions. In addition to the PROMUS Element Everolimus-Eluting Stent, the company is developing additional variations of a bare-metal and paclitaxel-eluting stent on the Element platform. The pivotal PERSEUS clinical trial compares the TAXUS Element stent to the TAXUS Express2 stent. The PERSEUS trial completed enrollment in October 2008, and the primary endpoint will be reported at the ACC conference in 2010.

"The brisk enrollment in the PLATINUM trial reflects the strong interest in this new platinum chromium stent platform," said Gregg W. Stone, M.D., professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy at the Columbia University Medical Center/New York-Presbyterian Hospital and principal investigator of the trial.

The Element Stent platform features a proprietary platinum-chromium alloy, designed specifically for coronary stents. This alloy, coupled with a new stent architecture, is designed to allow thinner struts, increased flexibility and a lower profile, while improving radial strength, recoil and visibility. In addition, all three Element stents incorporate the new Apex Dilatation Catheter technology, designed to enhance deliverability, Boston Scientific said.
The PROMUS Element, TAXUS Element and bare-metal Element stents are investigational devices and are limited by applicable law to investigational use only and are not available for sale.

For more information: www.bostonscientific.com

Related Content

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
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init