Feature | October 31, 2012

Synergy Stent With Bioresorbable Polymer Coating Cleared in Europe

Boston Scientific gains CE mark for everolimus-eluting platinum chromium coronary stent

October 31, 2012 — Boston Scientific Corp. received CE mark approval for the Synergy everolimus-eluting platinum chromium (PtCr) coronary stent system featuring an ultra-thin abluminal (outer) bioabsorbable polymer coating. The Synergy stent is unique in that its proprietary PLGA polymer and everolimus drug coating dissipate within three months. This has the potential to improve post-implant vessel healing and will eliminate long-term polymer exposure, a possible cause of late adverse events.  

"With the Synergy stent, drug release and polymer absorption occur in parallel and are complete at about three months after stent implantation," said Ian Meredith, M.B.B.S., Ph.D., professor and director of Monish Heart, Monish Medical Centre, Melbourne, Australia and principal investigator of the EVOLVE clinical study. "This exciting advance may improve long-term safety and efficacy compared to current durable polymer DES, and perhaps even reduce the need for prolonged dual antiplatelet therapy."

The timely absorption of the Synergy stent coating is the result of seven years of research and development to create what Boston Scientific believes to be the ideal blend of drug and polymer with advanced coating technologies. "In addition to its innovative coating, the foundation of the Synergy stent is our proprietary PtCr alloy and an enhanced stent design which allow for thinner struts, increased visibility and an extremely low crossing profile for easier deliverability," said Kevin Ballinger, president of the interventional cardiology division at Boston Scientific. "We believe that the result is a premium workhorse drug-eluting stent that eliminates long-term polymer exposure, promotes optimal healing and provides confident deliverability."

The Synergy stent is supported by a rigorous clinical program built on the EVOLVE six-month study results, which demonstrated non-inferiority to the Boston Scientific Promus Element stent for the primary angiographic endpoint of in-stent late loss, a proxy for efficacy. At 12 months, the Synergy stent demonstrated a target lesion revascularization (TLR) rate of 1.1 percent and a stent thrombosis (ST) rate of 0.0 percent. A pivotal trial, EVOLVE II, has been designed to support U.S. Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare approval of the stent system and is expected to begin enrollment later this year. EVOLVE II is a global, multicenter, randomized, controlled, pivotal trial that will enroll 1,684 patients in 160 sites across the globe. Boston Scientific anticipates additional studies to assess outcomes, including the potential for reduced dual antiplatelet therapy.

The Synergy stent will be available in a full range of sizes to select centers in Europe and other geographies by early 2013. This limited market release is expected to provide additional data to support the clinical and economic benefits of this bioabsorbable technology. A broad commercial launch of the stent is planned for early 2014.

The Synergy stent system is an investigational device and not available for sale in United States and Japan.

For more information: www.bostonscientific.com

Related Content

Technavio report, renal denervation devices, 2015
News | Renal Denervation| August 23, 2016
August 23, 2016 — Technavio analysts forecast the global...
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
News | Peripheral Arterial Disease (PAD)| August 22, 2016
Avinger Inc. recently announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’...
DMC Heart Hospital, Detroit Medical Center, complex percutaneous intervention education course, PCI, cath lab training
News | Cath Lab| August 22, 2016
The Detroit Medical Center (DMC) Heart Hospital recently completed a Complex Percutaneous Intervention education course...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
Covidien, Medtronic, TurboHawk, Atherectomy system

The Medtronic TurboHawk atherectomy system. 

Feature | Atherectomy Devices| August 18, 2016 | Dave Fornell
Due to poor outcomes from percutaneous transluminal angioplasty (PTA) ballooning of vessels alone, or of stenting in
Sapien III, Sapien 3, PARTNER III, FDA approval, expanded indication, intermediate risk patients

The Sapien 3 valve has a skirt of fabric at its base that has significantly reduced issues of paravalvular leak, which was an issue with the first generation Sapien device. 

Feature | Heart Valve Technology| August 18, 2016 | Dave Fornell
August 18, 2016 — The U.S.
Corindus Corpath, Acist Medical RXi and CVi, Fairview Southdale Hospital, Minnesota, cath lab
News | Cath Lab| August 17, 2016
Corindus Vascular Robotics Inc. and Acist Medical Systems Inc. are providing Fairview Southdale Hospital, Edina, Minn...
Sponsored Content | Videos | Inventory Management| August 15, 2016
Pacemakers, stents and bandages — keeping tracking of what is on hand and accurately capturing charges can be a chall
Overlay Init