Paris, France – On May 16, a live case using Firesorb® Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb®"), the second-generation fully bioresorbable scaffold in-house developed by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), was transmitted at EuroPCR in Paris. Meanwhile, MicroPort® released the one-year clinical and angiographic follow-up data of FUTURE I Trial, which attracted wide attention from the attendees.
On May 17, a live case of Firesorb® was broadcasted in EuroPCR 2017 Theatre Bordeaux. Professor Keifei Dou of Fuwai Hospital of Chinese Academy of Medical Sciences and his team implanted Firesorb® with assistance of OCT in treating LAD diagonal artery bifurcation lesion. The patient is a 58-year-old female with unstable angina. Based on OCT and QFR result of the patient, Professor Dou decided to use Provisional Stenting strategy. During the operation, Professor Dou respectively used semi-compliant balloon and non-compliant balloon to pre-dilate the lesion and successfully implanted a 3.25*18mm Firesorb® in the LAD, and then used 3.75mm non-compliant balloon to post-dilate the scaffold with assistance of OCT. Professor Dou emphasized the concept of optimizing stent implantation under the guidance of intravascular imaging including choosing the appropriate stent size, assessing and protecting the branch, fully post-dilating to make sure there is no stent malapposition. After the operation, the team had hot discussion with the experts of presidium and the attendees regarding the positioning and the visuality of the device in the X-ray and the degradation of BRS. The OCT result showed there is no malapposition with Firesorb® and the operation achieved successful outcome. The presidium experts from France, Malaysia, India and Singapore fully recognized the Firesorb® features such as its thin wall thickness and excellent stent expansion performance. The President of EuroPCR Jean Fajadet spoke highly of this live case, which once again demonstrated the outstanding innovative ability of the domestically developed medical devices to global cardiovascular interventional specialists.
On May 16, Professor Bo Xu of Fuwai Hospital of Chinese Academy of Medical Sciences released the one-year clinical and angiographic follow-up results of FUTURE I (angiographic, IVUS, and OCT findings). FUTURE-I Trial 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 0.17±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.
The Pivotal Clinical Study of Firesorb® FUTURE I Trial was launched in March and FUTURE III Clinical Trial is expected to be launched in the fourth quarter of 2017. The FUTURE series clinical trials will lay a great foundation for the following clinical studies of Firesorb® and the results of these clinical studies would provide evidence to support Firesorb®'s market launch in China.