Denver, US – From October 29 to November 2, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®")attended 2017 Transcatheter Cardiovascular Therapeutics ("TCT") held in Denver, US, and broadcasted a high-risk live case of Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"). TCT is the world's largest educational meeting specializing in interventional cardiovascular medicine and this year it focused on left main coronary artery disease treatment, bioresorbable stent, and transcatheter aortic valve replacement ("TAVR").
On November 1, a case of left main bifurcation lesion was broadcasted during the congress. The case was performed by Professor Shaoliang Chen of Nanjing First Hospital with the assistance of Professor Junjie Zhang and Professor Fei Ye. The patient is a 51-year-old female and the angiography shows the distal left main bifurcation with diffuse stenosis in proximal LAD and the lesion length of LCX more than 10mm. Professor Chen and his team adopted the strategy of DK crush with IVUS/OCT guidance, and successfully implanted a 30*13mm and a 30*38mm Firehawk® stent in LCX and LM-LAD. Afterwards, they used non-compliant balloon to proceed POT for dilating proximal LM. The postoperative IVUS/OCT results showed excellent stent apposition. The outstanding expansion capacity of Firehawk® was highly praised by the physicians and experts in attendance.
On October 31, Professor Bo Xu of Fuwai Hospital of Chinese Academy of Medical Sciences released the one-year clinical and angiographic follow-up results (clinical, angiographic, IVUS, and OCT findings) of FUTURE I Trial of Firesorb® Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb®"). FUTURE-I Trial is a perspective, single arm, First-in-Man ("FIM") clinical trial of evaluating the safety and efficacy of Firesorb® in the treatment of coronary heart diseases. It enrolled 45 patients. The primary endpoint is 30-day target lesion failure ("TLF"), including cardiac death, myocardial infarction of target vessel and ischemia-driven TLR (Target lesion Revascularization). The one-year clinical results showed that the occurrence of TLF is zero, the occurrence of patient-oriented composite endpoint ("PoCE") is 2.2%, and there is no death and ARC (Academic Research Consortium) defined stent thrombosis. The one-year in-device late lumen loss is 0.13mm and no restenosis occurred. The one-year clinical, angiographic, IVUS, and OCT results once again demonstrated Firesorb®'s feasibility, safety and efficacy in the treatment of single de novo lesions. Firesorb®'s pivotal clinical study FUTURE II trial, a prospective, multi-center, randomized clinical trial, aiming to evaluate the safety and efficacy of Firesorb® in the treatment of coronary artery atherosclerosis, successfully enrolled the first patient in August.
During the opening ceremony of TCT 2017, Dr. Juan F. Granada of Columbia University Medical Center, who is the CEO of Cardiovascular Research Foundation, said, the cardiovascular industry is experiencing faster transformation in the year of 2017, when imaging technology superior to 3D resolution has been invented, TAVR has been accepted in increasingly more medical centers worldwide, and artificial intelligence has started to be applied in patient care, image analysis and clinical studies. As a leading high-end medical device company in China and the whole Asia, MicroPort® will continue to innovate and make breakthroughs in the field of cutting-edge technologies such as TAVR and bioresorbable stent, to benefit more patients.