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

Resolute Onyx Stent With Improved Radiographic Visibility Found to Be Safe and Effective
News | Stents Drug Eluting | October 01, 2018
October 1, 2018 — Recent results from the BIONYX randomized clinical study showed the novel, thin-strutted, polymer-c
Boston Scientific Receives FDA Approval for Eluvia Drug-Eluting Vascular Stent
Technology | Stents Drug Eluting | October 01, 2018
Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA)...
Eluvia Drug-Eluting Stent Demonstrates Superior Patency in IMPERIAL Trial
News | Stents Drug Eluting | September 26, 2018
Positive 12-month data from the late-breaking IMPERIAL trial was presented at the 2018 Transcatheter Cardiovascular...
Titanium-Nitride-Oxide Stent Superior to Bioabsorbable DES in Acute Coronary Syndrome Patients

Image courtesy of Hexacath

News | Stents Drug Eluting | May 31, 2018
Late-breaking trial results presented at the EuroPCR Congress, May 21-24 in Paris, France, found the Optimax titanium-...
Orsiro DES Shows Lowest Two-Year Target Lesion Failure in BIO-RESORT Trial
News | Stents Drug Eluting | May 31, 2018
Two-year outcome data from the BIO-RESORT randomized controlled trial were presented in a late-breaking clinical trials...
OCT Reveals Excellent Healing Profile for Complex CAD Patients With Resolute Onyx DES
News | Stents Drug Eluting | May 29, 2018
Investigators recently unveiled clinical data from the independently run Onyx 1-Month OCT Study showing strong early...
Abbott's Xience Sierra Stent Receives FDA Approval
Technology | Stents Drug Eluting | May 25, 2018
Abbott announced it received approval from the U.S. Food and Drug Administration (FDA) for Xience Sierra, the newest...
Medtronic Launches 2 mm Onyx DES
Technology | Stents Drug Eluting | February 26, 2018
February 26, 2018 – Designed specifically for small vessels, Medtronic plc announced U.S.
Detroit Medical Center Heart Hospital Uses Michigan's First EluNIR Drug-Eluting Stent
News | Stents Drug Eluting | February 19, 2018
February 19, 2018 — The Detroit Medical Center’s (DMC) interventional cardiology team at Heart Hospital recently beca
Biotronik Symposium Highlights Differing Roles of Drug-Eluting Stents and Magnesium Scaffolds in Clinical Practice
News | Stents Drug Eluting | January 25, 2018
January 25, 2018 – Data presented at the Biotronik-sponsored...
Overlay Init