Beijing, China – On August 24, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") announced that Firesorb®'s pivotal clinical study FUTURE II trial successfully enrolled the first patient in Fuwai Hospital of Chinese Academy of Medical Sciences. Firesorb® Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb®") is the world's first second-generation fully bioresorbable scaffold.
FUTURE II trial is a prospective, multi-center, randomized clinical trial, aiming to evaluate the safety and efficacy of Firesorb® in the treatment of coronary artery atherosclerosis. The clinical trial will enroll 430 patients in 22 hospitals in China. The subjects will be randomized 1:1 into Firesorb® group or Abbott Xience family everolimus eluting stents group. The primary endpoint of the clinical trial is 12-month in-segment late loss, and the patients enrolled in FUTURE II trial will continue follow-up to five years. The principal investigator of the trial is Academician Runlin Gao of Fuwai Hospital of Chinese Academy of Medical Sciences.
On August 8, the FUTURE II initial meeting was hosted in Fuwai Hospital of Chinese Academy of Medical Sciences. The meeting was chaired by Professor Bo Xu of Fuwai Hospital of Chinese Academy of Medical Sciences. Academician Runlin Gao, Professor Yuejin Yang and Professor Shubin Qiao of Fuwai Hospital of Chinese Academy of Medical Sciences respectively delivered speeches on behalf of the hospital to show that the FUTURE II trial was highly valued and strongly supported by the hospital. Afterwards, Ming Zheng, Vice President of Clinical Science & Medical Affairs and President of MicroPort® Knowledge & Action Institute, gave a speech on behalf of MicroPort® to express the company's expectation on the clinical trial as well as its appreciation for the support of investigators. Professor Bo Xu of Fuwai Hospital of Chinese Academy of Medical Sciences introduced the program design, inclusion criteria/exclusion criteria, trial design, observation index, trial process, and adverse effects judgment and reporting of FUTURE II trial, and had in-depth discussions with the attending investigators regarding these aspects. The meeting also specified the assignments and quality requirements of each participant and demonstrated the EDC system and random system to ensure the FUTURE II trial can be completed with good quality in time and also to facilitate other centers to process the clinical trial. In the meeting, investigators had hot discussions on the trial process and the device features, and determined the correct method to conduct the trial. They all agreed to process the trial according to the GCP and the Competent Authorities' requirements.
MicroPort® started the R&D of Firesorb® from 2009. Its clinical trials comprise of FUTURE I, FUTURE II and FUTURE III. The first patient of Firesorb® FUTURE I was enrolled in January 2016 in Fuwai Hospital of Chinese Academy of Medical Sciences, and the six-month and 12-month angiographic results of FUTURE I were respectively released during 2016 Transcatheter Cardiovascular Therapeutics ("TCT") and 2017 China Interventional Therapeutics ("CIT"), which fully demonstrated Firesorb®'s safety and efficacy in preliminary clinical applications. Another pivotal study of Firesorb® - FUTURE III clinical trial is expected to be launched in the second quarter of 2018. 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.
Firesorb ® is the fourth-generation coronary stent system in-house developed by MicroPort®. It is indicated for primary coronary lesions in patients with ischemic heart disease. Compared with traditional permanent metal stents, the bioresorbable scaffold uses special bioresorbable material, and is expected to degrade and be absorbed in vivo completely within three years after implantation, with no permanent metal supports within the blood vessels, and thus vascular structures can be restored to its natural state. The bioresorbable scaffold can effectively reduce the incidence of late stent thrombosis and other adverse events, which is conducive to coronary positive remodeling and postoperative imaging diagnosis.
As a revolutionary product in treating cardiovascular diseases, the bioresorbable scaffold was launched in the European markets in 2012, but none has gained regulatory approval in China yet. In June 2016, Firesorb® was granted the Green-Path status by China Food and Drug Administration ("CFDA"), a special fast-track procedure for innovative medical devices to gain CFDA approval, which will significantly shorten the approval time. Once launched in the China market, Firesorb® will provide a better solution to domestic patients with coronary heart diseases.