Paris, France – On May 17, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") hosted a satellite meeting of "Firehawk® TARGET Series Clinical Trial Program" at EuroPCR in Paris, and released the clinical data of Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") Clinical Trials TARGET All Comer, TARGET I and TARGET II.
The satellite meeting was chaired by Professor William Wijns, M.D., PhD, National University of Ireland Galway, Ireland,, who is the president of EuroPCR, and Dr. Martin B. Leon of Columbia University in the City of New York. Dr. Martin B. Leon introduced the global clinical trial programs of Firehawk® including the completed TARGET series in China, the undergoing TARGET All Comer Clinical Trial in Europe, and the TARGET DAPT Trial and TARGET SAFE Trial short-range dual antiplatelet therapy program that will be launched in the near future. Dr. Andreas Baumbach of Queen Mary University of London shared some cases of TARGET All Comer Trial. Afterwards, Professor William Wijns announced the three-month Optical Computerized Tomography ("OCT") data from the TARGET All Comer trial which demonstrated early vessel healing treated with Firehawk® and showed non-inferiority results compared to Xience family stents. The mean neointimal thickness was 75.5μm for Firehawk® and 82.3μm for Xience (P non-inferiority <0.001, with a 90% two-sided confidence interval). This good result is also supported by a percentage of malapposed and uncovered struts of 0.0% (for Firehawk® and Xience arms).
Professor Bo Xu of Fuwai Hospital of Chinese Academy of Medical Sciences released the five-year follow-up data of TARGET I and TARGET II randomized clinical trials, and the result full demonstrated Firehawk® has excellent early vessel healing and long-term safety and efficacy. In the TARGET I Clinical Trial, when treating simple lesions, the five-year target lesion failure ("TLF") of Firehawk® and Xience arms stood at 5.7% and 6.6% respectively which no significant difference between the two arms. In the TARGET II Clinical Trial, when treating moderate-risk lesions, the five-year TLF of Firehawk® was merely 8.1%. More importantly, in the TARGET I Clinical Trial, the five-year thrombosis rate of Firehawk® was zero, and in the TARGET II Clinical Trial, the five-year thrombosis rate of Firehawk® was 0.7%. Both of the results demonstrated the safety and efficacy in long-term clinical trials. The experts of presidium at EuroPCR said the innovative Firehawk® is one of the best drug-eluting stents in PCI treatment.
In addition, during the meeting of releasing the OCT/IVUS imaging results on May 18, Dr. Andreas Baumbach once again shared the three-month OCT data from the TARGET All Comer Trial, which showed Firehawk® has superior results in terms of acute gain data.
The revolutionary third-generation DES Firehawk® is the result of eight years of research and development of MicroPort® and it is the world's first and only target eluting stent. As the world's lowest drug dosage stent, Firehawk® combines the merits of the bare metal stent and DES. It adopts unique in-groove abluminal coating design and target-eluting technology, which allow Firehawk® to achieve the same clinical efficacy with significantly low drug loading, benefiting vascular early healing.