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FIREHAWK, safety and effectiveness approved by early clinical studies

SAN FRANCISCO, CALIF.--Early studies provide evidence that the FIREHAWK bioabsorbable polymer sirolimus-eluting stent is safe and effective in CAD patients.
Run-Lin Gao, MD, of Fu Wai Hospital and National Center for Cardiovascular Diseases of China, presented an update of the 4- and 13-month results from the FIREHAWK First-in-Man Study, which assessed the preliminary safety and feasibility of the new-generation DES system (MicroPort). The prospective, single-center pilot study included adult patients with de novo, single lesions in native coronary arteries.
FIREHAWK is a targeted-release abluminal groove filled bioabsorbable polymer SES developed by MicroPort.In the study, the device success rate was 95.7% and lesion and clinical success rates were both 100%.Overall, there was zero incidence of MACE — the primary endpoint of the study — during the 13-month follow-up period. One patient died 5 days after the index procedure due to hemorrhagic stroke, Gao said. Only one target vessel revascularization occurred in a non-target lesion. There was no evidence of thrombosis.
Angiographic follow-up showed that the average in-stent late lumen loss was 0.13 mm at 4 months and 0.16 mm at 13 months. Four-month optimal coherence tomography was performed in 14 of 17 eligible patients, for which the researchers analyzed 14 stented segments every 0.3 mm for 11,551 struts. Results showed that 96.2% were fully covered; of the remaining 3.8%, only 0.1% weremalapposed.
"The preliminary safety and feasibility of the FIREHAWK sirolimus-eluting stent has been confirmed by clinical, angiographic and OCT follow-up," Gao said. "With these promising data, a pivotal randomized trial has been initiated." Gao provided an update on the TARGET Clinical Program, which includes the premarket clinical trials of the FIREHAWK First-in-Man Study, TARGET I trial and TARGET II Registry, all of which involve the FIREHAWK stent.
The program will enroll 995 patients. As of May 2011, researchers have enrolled 510 implant cases in TARGET I, which will compare FIREHAWK and Xience V. The primary clinical endpoint ofTARGET II is the device-oriented composite of cardiac death, target vessel MI or ischemia-driven target lesion revascularization at 1 year. More than 30 clinical centers in China will be involved in the program.