News | February 06, 2007

DES Trial to Study Complexities of CVD in Women

Feb. 7, 2007 — Abbott has announced its plan to launch the world's first drug-eluting stent clinical trial solely in women. Performance of the Xience V Everolimus Eluting Coronary Stent System will be the focus of the SPIRIT WOMEN trial, designed specifically to study CVD in women and how it differs from men. Xience V is not FDA cleared for commercial sale in the U.S.

Approximately 2,000 women from 100 sites throughout Europe, Asia-Pacific, Canada and Latin America will be included in the trial, which will evaluate patient and disease characteristics specific to women as well as treatment outcomes such as rate of death, heart attack and target vessel revascularization (TVR) and potential risk of stent thrombosis. The trial will yield specific data on CVD and how it is diagnosed in women.

According to the National Center on Health Statistics, more women than men die of cardiovascular disease every year, yet women receive only 33 percent of angioplasties, stents and bypass surgeries; 28 percent of implantable defibrillators; and 36 percent of open-heart surgeries. This may be partially explained by the greater diagnosis challenges in women, who exhibit different, and often more gradual and subtle symptoms such as shortness of breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue and back, shoulder blade or jaw pain.

"The SPIRIT WOMEN trial will contribute to therapy access by increasing awareness and understanding of CVD in women while further evaluating the performance of our XIENCE V drug-eluting stent in this patient population," said John M. Capek, Ph.D., president, Abbott Vascular. "As a leader in vascular care, Abbott believes that it is our role not only to provide the best technologies, but also to ensure that they are being used effectively in as broad a patient population as possible."

Pending requisite approvals from regulatory bodies and clinical trial sites, patient enrollment may begin by mid-2007.

For more details visit www.abbott.com .

Related Content

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...
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
Overlay Init