Technology | May 25, 2011

FDA Approves Xience Nano Stent to Treat Small Coronary Vessels

May 25, 2011 – The U.S. Food and Drug Administration (FDA) cleared the Xience nano everolimus-eluting coronary stent system for the treatment of coronary artery disease in small vessels. The Xience nano, which is based on the same platform as the Xience V everolimus-eluting coronary stent, offers physicians in the United States a new option for treating patients with coronary artery disease in vessels as small as 2.25 mm in diameter.

"The treatment of small vessels is often complex and associated with higher rates of complications compared to larger vessels," said Marco Costa, M.D., Ph.D., professor of medicine, director of the Interventional Cardiovascular Center, and director of the Center for Research and Innovation, Harrington-McLaughlin Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, Ohio, and principal investigator of the SPIRIT Small Vessel clinical trial. "I am confident that the highly deliverable Xience nano stent, with its thin struts and effective everolimus-eluting platform, will help physicians treat their patients who have coronary artery disease in small vessels."

FDA approval of Xience nano was supported by results from the SPIRIT Small Vessel clinical trial, which showed very low late loss (a measure of vessel re-narrowing) of 0.20 mm and a target lesion failure (TLF) rate of 8.1 percent, which is comparable to results observed in the SPIRIT clinical trials with Xience V. TLF is defined as a composite measure of important efficacy and safety outcomes for patients and includes cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR).

Small vessels often are associated with increased levels of restenosis, or tissue re-growth, following a stent implantation. With its cobalt chromium stent design, high deliverability and everolimus drug coating used to prevent abnormal tissue growth, Xience nano is designed to be an optimized treatment for coronary artery disease in patients who have small vessels.

Boston Scientific also announced its launch of the 2.25 mm Promus stent, which is a private-labeled Xience nano everolimus-eluting coronary stent. It is manufactured by Abbott and distributed by Boston Scientific under a 2006 agreement, when Abbott purchased the Xience stent technology from Boston.

For more information:

Related Content

Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
Abbott will end sales of the Absorb bioresorbable stent scaffold, pulling it off the market September 14, 2017.
Feature | Stents Bioresorbable| September 08, 2017 | Dave Fornell
September 8, 2017 — Abbott Vascular has announced it will end commercial sales of its Absorb bioresorbable vascular s
Biotronik's Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial
News | Stents Drug Eluting| September 01, 2017
September 1, 2017 — Biotronik recently announced data from the BIOFLOW-V randomized trial comparing Orsiro and Xience
Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Onyx DES 2.0 mm stent meets primary endpoints in small vessels
News | June 12, 2017
June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failur
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Overlay Init