Shanghai, 12 October,2012--At GW-ICC&APHC (the Great Wall International Congress of Cardiology & Asia Pacific Heart Congress), Mr. Bo Xu, MD, Director of Fu Wai Hospital and National Center for Cardiovascular Diseases of China, presented the latest primary endpoint data on behalf of Run-linGao, MD, the principalinvestigator of Firehawk® TARGET I Randomized Controlled Trial (RCT). Firehawk® Rapamycin Target Eluting Coronary Stent is a third generation drug-eluting stent system designed and manufactured by MicroPort Medical.
TARGET I RCThadenrolled 460 patients (229 in Firehawk® and 231 in Xience V). The RCT has a non-inferiority design with the primary endpoint of the in-stent late lumen loss at 9 months. Angiographic follow-up at 9 months (88.9% follow-up rate) showed that the primary endpoint of the RCT was achieved by 0.13±0.24mm in late lumen loss for Firehawk® and 0.13±0.18mm for Xience V. The non-inferiority is achieved. Furthermore, in the 1 year clinical follow up,there is no evidence of in-stent thrombosis for both Firehawk® and Xience V and the rate of TLF is 2.2% for both stents.
The experts comment that, with the current published data on Firehawk® TARGET trials, the feasibility and superiority of the "Target Release" feature on Firehawk® stent has been proved. The abluminal groove design of the Firehawk® stent allows the reduced drug content compared to previous generation drug eluting stents.The grooves are only on the outer surface of the struts, and the drug polymer matrix is only stored inside the grooves. This unique design enables lower rapamycin drug dosageby targeting the vessel wall with the goal of minimizing long-term inflammation and decreasing stent thrombosis rate, while maintaining anti-restenosis effect and therapeutic rapamycin level. Firehawk® Rapamycin Target Eluting Coronary Stent System is a new generation drug eluting stent system with better safety and efficacy.
Mr.QiyiLuo, Chief Technology Officer of MicroPort, made following comments. "Firehawk®, the third generation of MicroPort drug eluting stent, is the first and only stent that combine the groove technology with polymer controlled release. We believe that the good results of the pre-marketing Firehawk® clinical trials will lay a solid foundation for its future. On Oct 23rdat TCT conference in the U.S, we are going to publish Firehawk® clinical data to the word at the Next-Generation DES and Bioabsorbable Scaffoldsforum. Please stay tuned."
Firehawk® has entered into the stageof clinical follow-up and data processing after its completion of all patientenrollments. There are three phases for Firehawk® clinical trials: FIM, TARGET I and TARGET II. Among them, FIM has complete enrollment in January 2010. Angiographic Follow-up showed that in-stent late lumen loss was 0.13±0.18 mm at 4 months and 0.16±0.07 mm at 13 months.4-month OCT (optimal coherence tomography) follow-up results showed that endothelial cell coverage rate is 96%. Up to now, no death and myocardial infarction(MI)and target vesselrevascularization(TVR)wereobserved through 2-year period of follow-up.
TARGET I, a prospective multicenter randomized clinical trial, had enrolled 50 long cohort implant cases with average lesion length over 35mm in May 2011. 77 stents were successfully implanted. Angiographic Follow-up showed that in-stent late lumen loss was 0.16±0.16mm at 9-month. There's no incidence of cardiac death or ischemia-driven target lesion revascularization and zero incidence of in-stent restenosis and thrombosis.
Mr. YiminXu, Vice President of Regulatory and Clinical Affairs of MicroPort, commented the following. "Firehawk® has enrolled 1261 implant cases in premarket clinical trials totally. It is the largest-scale premarket clinical trial of coronary DES in China.In addition, the trialis the first one that in compliance with SFDA's Clinical Trial Guidelines for Coronary Drug-Eluting Stents (Pending draft for approval)."
The latest data showed that the
cardiovascular-related disease patients has increased to 230 million (one in every five adults) in China. There are 3.5 million patients died because of cardiovascular-related disease. With the increasingin the incidence of the disease in cardiovascular disorders and needs for stent-implantation, Firehawk®
is expected to provide further benefitsto doctors, physicians and patients. It is also the goal that embedded in the MicroPort's core value "A Brand that Belongs to Doctors and Patients".