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

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
Overlay Init