Micell Technologies‘ sirolimus-eluting absorbable polymer coronary stent met the primary endpoint in the Dessolve III clinical trial, according to 12-month data published at EuroPCR. The stent demonstrated non-inferior safety and effectiveness outcomes compared to Xience‘s everolimus-eluting coronary stent system.
The 1,400-patient study evaluated the MiStent in patients with symptomatic coronary artery disease, including chronic stable angina, silent ischemia and acute coronary syndrome. All study participants qualified for percutaneous coronary interventions.
“MiStent met the primary non-inferiority endpoint of target lesion failure at 12 months, with numerically lower TLF and target lesion revascularization rates. TLR rates for MiStent were numerically lower at all time points following the procedure, and by 1 year that difference grew to 1.2%. These results speak to the potential value of slower, controlled drug release allowing for sustained drug presence,” Dr. Robbert de Winter, from the Academic Medical Center in Amsterdam, said in prepared remarks. “These trial results, in conjunction with the 5-year results from the Dessolve I and II studies, provide further evidence of the potential value of this technology relative to current DES performance expectations from the perspectives of both safety and efficacy.”
MiStent has CE Mark approval in the European Union, but is not approved in the U.S.
“These results appear to validate the unique premise of Micell’s supercritical fluid technology platform, which allows drug in micro-crystalline form to be combined with a fast-dissolving polymer and applied as a coating on an ultra-thin-strut cobalt chromium stent,” Micell chief medical advisor Dr. Dennis Donohoe added. “These unique features have the potential to offer meaningful clinical and economic benefits to patients and the healthcare system.”
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