News | Stents Drug Eluting | January 08, 2016

Stentys Completes Enrollment of MiStent Randomized Trial Against Xience

DESSOLVE III clinical trial enrolled 1,400 “all-comers” patients, with primary endpoint of non-inferiority comparison of target lesion failure

January 8, 2016 — In December, Stentys announced completion of patient enrollment in DESSOLVE III. The 1,400-patient randomized clinical trial will compare the MiStent SES sirolimus eluting absorbable polymer coronary stent system to Abbott’s Xience stent.

The MiStent SES is a balloon-expandable stent designed to improve long-term clinical outcome of patients treated with conventional “workhorse” stents. The device features Crystalline Sirolimus technology, where thousands of microscopic drug crystals slowly dissolve in the surrounding tissue after absorption of the polymer carrier. This allows for a gradual, linear and much longer elution of sirolimus than with other competitive stents, hence reducing vessel over-scarring.

With 2 percent re-intervention rate (target lesion revascularization) at three-year follow-up in previous clinical trials, MiStent SES was shown to be superior to Xience in a retrospective propensity analysis presented by Alexandra Lansky, M.D., New Haven, Conn., during the last EuroPCR conference in Paris.

DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent SES and Xience in a “real world, all-comers” patient population of 1,400 patients in 20 hospitals in Europe. Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia or acute coronary syndrome, and qualified for percutaneous coronary interventions. The primary endpoint is a non-inferiority comparison of target lesion failure (TLF) of the MiStent SES group versus the Xience group at 12 months post-procedure.

MiStent SES has already received CE Marking. Stentys is MiStent exclusive distributor worldwide, except in the United States, Canada, China, South Korea and Japan, and is currently conducting a controlled launch in select countries in Europe, Middle East and Asia.

For more information: www.stentys.com


Related Content

News | Cath Lab

December 20, 2023 — Jason R. McCarthy, Ph.D., associate professor of biomedical research and translational medicine and ...

Home December 20, 2023
Home
News | Cath Lab

October 26, 2023 — Royal Philips, a global leader in health technology, announced the latest results demonstrating the ...

Home October 26, 2023
Home
News | Cath Lab

October 25, 2023 — Shockwave Medical, Inc., a pioneer in the development and commercialization of transformational ...

Home October 25, 2023
Home
News | Cath Lab

October 20, 2023 — Over the coming days, Philips will be presenting its latest solutions in cardiology and new late ...

Home October 20, 2023
Home
News | Cath Lab

October 16, 2023 — GE HealthCare (Nasdaq: GEHC) announced US FDA 510(k) clearance of Allia IGS Pulse - the latest ...

Home October 16, 2023
Home
News | Cath Lab

October 16, 2023 — Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, announced the first U.S ...

Home October 16, 2023
Home
News | Cath Lab

September 13, 2023 — A diagnostic test, first offered in the United States at University Hospitals (UH) Harrington Heart ...

Home September 13, 2023
Home
News | Cath Lab

August 2, 2023 — Teleflex Incorporated, a leading global provider of medical technologies, announced the U.S Food and ...

Home August 02, 2023
Home
News | Cath Lab

July 13, 2023 — Mount Sinai Queens announced the opening of a new cardiac catheterization lab that will provide rapid ...

Home July 13, 2023
Home
News | Cath Lab

June 21, 2023 — Royal Philips, a global leader in health technology, announced it has teamed up with BIOTRONIK (Lake ...

Home June 21, 2023
Home
Subscribe Now