News | June 01, 2008

Abbott Submits XIENCE V Application for Approval in Japan

June 2, 2008 - Abbott has submitted an application for Seizo Hanbai Shonin (Marketing Authorization License) to Japan's Ministry of Health, Labour and Welfare (MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) to gain approval for its XIENCE V Everolimus Eluting Coronary Stent System to treat coronary artery disease.

The Shonin application for XIENCE V consisted of safety and efficacy data from the SPIRIT III clinical trial, including data from a Japanese patient population. As previously reported, results from the SPIRIT III U.S. pivotal clinical trial compared XIENCE V to Boston Scientific's TAXUS paclitaxel-eluting coronary stent system in the primary endpoint of in-segment late loss at eight months.

The XIENCE V stent utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is built upon Abbott's MULTI-LINK VISION Coronary Stent System, a bare metal stent. The VISION platform reportedly has a flexible design and facilitates ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery, according to the manufacturer.

Abbott's Shonin submission for XIENCE V included data from SPIRIT III, a large-scale, randomized clinical trial of 1,002 patients conducted in the United States. The submission also included data from two non-randomized registry arms: the SPIRIT III Japan Registry of 88 patients and the SPIRIT III 4.0mm Registry of 69 patients conducted in the U.S.

For more information: www.abbott.com

Related Content

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...
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.
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
Biosensors, BioFreedom drug-coated stent, LEADERS FREE II IDE trial, first patient, U.S. pivotal study
News | Stents Drug Eluting| March 03, 2017
Biosensors International Group Ltd. announced in February enrollment of the first patient in LEADERS FREE II, its new...
CeloNova Cobra Pzf stent
Technology | Stents| March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
Synergy stent, abluminal polymer DES, bioresorbable polymer DES, bioresorbable polymer metallic stent

The Synergy stent is the first FDA cleared drug-eluting stent to use a bioresorbable polymer drug carrier. When the polymer dissolves after about four months, the devices become a bare metal stent. The technology is supposed to reduce the rate of late stent thrombosis due to vessel inflammation caused by durable polymers.

Feature | Stents Bioresorbable| January 17, 2017 | Dave Fornell
One of the big advancements in drug-eluting stent (DES) technology has been the development of bioresorbable polymers
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents| January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
EXCEL Trial, TCT 2016, drug-eluting stents, CABG, surgery left main heart disease, LMCAD

Gregg W. Stone, M.D., presenting the EXCEL data at TCT 2016 during a standing room only late-breaking trial session.

Feature | Stents| January 12, 2017 | Dave Fornell
The biggest news from the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting this past fall was the results
Overlay Init