Paris, France – On May 23, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") hosted a satellite meeting of "Firehawk®: New Technology of DES" and TARGET All-Comer Investigator Workshop at EuroPCR in Paris. Meanwhile, a live cases using Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") to treat high-risk bifurcation disease was broadcasted at the conference.
On May 23, a live case in which Professor Kefei Dou, Professor Jie Qian and Professor Lei Song of Fuwai Hospital used Firehawk® to treat left main bifurcation and LAD/Diag bifurcation. The female patient, 54, suffered from exertional angina. The physicians adopted DK-Crush technique to successfully implant Firehawk® stents of 2.25*13mm, 4.0*23mm, 3.0*13mm, and 3.0*23mm into the lesion. The operation achieved successful result without malapposition, showing Firehawk® has excellent crossability for side branches and good performance in treating complicated lesion.
On May 23, MicroPort® hosted Firehawk® satellite meeting, co-chaired by Professor William Wijns, president of EuroPCR, M.D., PhD, National University of Ireland Galway, Ireland, Dr. Martin B. Leon of Columbia University in the City of New York, and Professor Bo Xu of Fuwai Hospital of Chinese Academy of Medical Sciences. Dr. Martin B. Leon introduced the global clinical trial programs of Firehawk®. Dr. Andreas Baumbach of the St Bartholomew's Hospital in London and Professor Niels Van Royen of VU University Medical Center in the Netherlands interpreted the 12-month result of its TARGET All-Comers ("TARGET AC") trial. The results of the TARGET AC trial demonstrated that vessels treated with the Firehawk® showed non-inferiority results when compared to vessels treated with the Xience family of drug eluting stents. The primary endpoint of non-inferiority for the Firehawk® stent compared to the Xience family stent was met with a 12-month TLF rate in the intent-to-treat population of 6.1 percent versus 5.9 percent, respectively (pnon-inferiority = 0.004). The primary QCA substudy endpoint of non-inferiority for the Firehawk® compared to the Xience family stent was met with an in–stent lumen late loss at 13-months in the per treat population of 0.17 ± 0.05 mm versus 0.11 ± 0.05 mm (P non-inferiority =0.024), respectively. This results further proved that Firehawk® can achieve the same efficacy with only 1/3 dosage versus similar products. Afterwards, Dr. Henning Kelbæ of Roskilde University Hospital in Denmark shared Firehawk® cases in TARGET AC clinical program and had discussions with other experts regarding the target-eluting technology, design rationale, and clinical data of Firehawk®. Dr. Martin B. Leon said: "I can see this device (Firehawk®) perform exactly as good as any other DES market leaders." Professor Andreas Baumbach said:" This is a stent that has all the features for everyday use: large cell for good side branches, good radio force and now with safety and efficacy data. So I think this is a workhorse stent."
On the night, MicroPort® hosted a TARGET AC Investigator Workshop. Jonathan Chen, MicroPort® International Business Officer first introduced the investigators of the TARGET AC clinical trial. Afterwards, Professor Bo Xu introduced the global clinical study programs of Firehawk® - since the launch of TARGET FIM in 2009 following the first patient enrollment, the TARGET series studies enlarged its coverage from China to Europe, Southeast Asia, North America, and South America with nearly 17,000 patients enrolled in this large-scale global clinical studies. The discussion session was chaired by Professor William Wijns, Professor Andreas Baumbach, and Professor Bo Xu. Dr. Ming Zheng, Vice President, Clinical Science & Medical Affairs of MicroPort®, had a discussion with investigators regarding how to design and run a high quality pivotal device clinical trial in Europe for an eastern device. In the workshop, MicroPort® awarded five study sites of TARGET AC clinical trial to offer heartfelt gratitude for their contribution to this important study.
The revolutionary third-generation drug-eluting stent ("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 technique, which allows Firehawk® to achieve the same clinical efficacy with significantly low drug loading, benefiting vascular early healing. The TARGET AC trial is a prospective, multi-center, randomized controlled clinical trial consisting of entirely European based patients. This clinical study enrolled its first patient in December 2015 and completed enrollment of its last patient in October 2016. In total, there were 1,654 patients enrolled from 21 clinical study sites throughout Europe. In addition, the trial design included an OCT (Optical Coherence Tomography) sub-study consisting of 50 patients at three months post implantation and a QCA (Quantitative Coronary Angiography) sub-study consisting of 176 patients at 13 months. As the first Chinese medical device company launched a large-scale post-market clinical trial in Europe, MicroPort® is extremely careful in carrying out the TARGET global clinical programs. Up to date, over 2,900 patients were enrolled in TARGET series clinical programs. The increasingly more clinical data have further proved Firehawk®'s safety and efficacy.