Technology | March 27, 2007

ACC2: SPIRIT III Proven Safe and Effective, Boston Scientific Announces

The results of Boston Scientific's pivotal SPIRIT III clinical trial reaffirmed prior safety and efficacy data for the market-leading TAXUS Express2 Paclitaxel-Eluting Coronary Stent System and provided early positive data for the XIENCE V (PROMUS) Everolimus-Eluting Coronary Stent System. The XIENCE V Everolimus-Eluting Coronary Stent System is manufactured by Abbott and distributed on a private label basis by Boston Scientific as the PROMUS Everolimus-Eluting Coronary Stent System. Boston Scientific is the first company to offer two distinct drug-eluting stent platforms.

Results of the U.S.-based, non-inferiority trial were presented at ACC.

"This trial is important as it reinforces our understanding of the proven performance of the TAXUS Stent and generates enthusiasm for the early clinical data of this deliverable Olimus, the PROMUS Stent," said Martin B. Leon, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation,New York.

Gregg W. Stone, M.D., the trial's Principal Investigator, reported that the primary endpoint of angiographic in-segment late loss at eight months met its non-inferiority margin between the TAXUS Stent (0.28mm) and XIENCE V (PROMUS) Stent (0.14mm), pNI

The TAXUS Stent and XIENCE V (PROMUS) Stent demonstrated impressive safety results through nine months. In particular, the TAXUS Stent reported zero percent (0 percent) Stent Thrombosis and zero percent (0 percent) Q-Wave Myocardial Infarction (MI, or heart attack).

"In today's safety-conscious environment, it is reassuring to see both the TAXUS and PROMUS Stents performed exceptionally well in the SPIRIT III trial on multiple measures," said Hank Kucheman, Senior Vice President and Group President of Boston Scientific's Interventional Cardiology business. "We were particularly encouraged by the zero thrombosis and Q-wave MI rates for TAXUS."

Boston Scientific offers two highly deliverable and complementary drug- eluting stent technologies. The PROMUS Stent has CE Mark approval and is distributed in most European countries and other international markets. The PROMUS Stent is an investigational device in the U.S. and not yet approved for sale. It is currently under FDA review with an anticipated U.S. launch in 2008.

Related Content

Lexington Begins HeartSentry Clinical Trial
News | Clinical Study | 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 | Clinical Study | 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 | Clinical Study | 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 | Clinical Study | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study | 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 | Clinical Study | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init