On March17th, 2012, during the workshop "Latest Clinical Trials' Announcements and First Report on Feature Research” at CIT2012, Run-Lin Gao, MDof Fu Wai Hospital and National Center for Cardiovascular Diseases of China, presented the updated primary endpoint results of randomized controlled clinical trial ofFirehawkTARGET I Long Stent Group Research Study. TARGET I Long Stent Group Research Study was performed in 50 eligible patients with average lesion length over 35 mm. The success rate was 100% in all 77 implants. The late loss was 0.16±0.16mm at 9-month angiographic follow-ups (the follow-up rate is 92%). No death and myocardial infarction (MI) and target vessel revascularization (TVR) were observed through 1-year period of OCT follow-up. The latest data indicates that the efficacy and safety of Firehawk stent are excellent intreatment of ultra-long coronary lesions. The results of the randomized TARGET I Group Research Study will be released at TCT 2012.
The FirehawkRapamycin Target Eluting Coronary Stent System is the third generation of Drug-eluting Stent developedproprietarily by MicroPort. It is the world’s first stent that incorporatedgroovingtechnicwith polymer control release technology. The rapamycin and polylactic acid coating is only stored in outer surface of the groove and the inner and side of stent remainbare metal made by laser-cutting cobalt-chromium alloy. When the stent expands in the area of lesion, the drug inside the groove slowly releases into the vessel wall and inhibit proliferationof smooth muscle cell. Different from the traditional drug-eluting stents, the surface and side of Firehawk are not coated with drugs and polymers.
To date, all patient enrollments for the pre-marketing clinical study of Firehawk have been completed. The clinical study has now entered the clinical follow-up and data-processing stage.There are three phases in Firehawk pre-marketing clinical investigation study: FIM (First-In-Man), TARGET I and TARGET II. The patient enrollments for FIM was completed in January 2010. According to results from the 4-month OCT follow-up, 4- and 13-month angiographic follow-ups and 1-2 years of clinical follow-ups, the endothelial-cover ratio is 96% and late loss was 0.13±0.18mm at 4-month angiographicfollow-ups. The late loss was 0.16±0.07mm at 13-month angiographic follow-ups. No death and myocardial infarction (MI) and target vessel revascularization (TVR) were observed through 2-year period of OCT follow-up.