Shanghai, China – On March 11, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") hosted the Investigator Meeting (The initial meeting ) for pivotal clinical study of Firesorb® — FUTURE II Trial in its Shanghai headquarters, and around 40 investigators from over 20 participating hospitals attended the meeting. Firesorb® Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb®") is the second-generation fully bioresorbable scaffold in-house developed by MicroPort®.
The meeting was chaired by Ming Zheng, Vice President of Clinical Science & Medical Affairs and President of MicroPort® Knowledge & Action Institute. During the meeting, MicroPort® Chief Marketing Officer Bo Peng and the Principal Investigator Professor Runlin Gao of Fuwai Hospital of Chinese Academy of Medical Sciences delivered speeches respectively on behalf of MicroPort® and FUTURE II investigators. Firesorb® is currently the first and only bioresorbable vascular scaffold with thickness less than 150μm in China, and its thin-wall design is conducive to rapid revascularization after stent implantation, thereby reducing the risk of scaffold thrombosis. As less material is used to make the scaffold, the degradation period will be further shortened. In addition, Firesorb® adopts the same targeting elution technique as MicroPort®'s third-generation Firehawk® Rapamycin Target Eluting Coronary Stent System, as it only retains the drug on the abluminal of the scaffold, which reduces the dose of drug, enhances the efficiency of the treatment, and prevents a large amount of drug residual from remaining in the body for a long time.
Professor Bo Xu of Fuwai Hospital of Chinese Academy of Medical Sciences introduced the study protocol of FUTURE II Trial and had in-depth discussions with the attending investigators on its design principles and inclusion criteria/exclusion criteria etc. Afterwards, Professor Runlin Gao shared the best optimization implantation strategy for bioresorbable vascular stent/scaffold on the basis of evidence-based medicine, that is PSP (or 5P) the best technique for implantation of bioresorbable vascular scaffold, including good preparation for lesions, appropriate scaffold size combined with coronary imaging methods, and necessary post-dilation after scaffold implantation. Professor Gao also emphasized scaffold expansion limitation and post-procedure dual antiplatelet therapy. Meanwhile, the investigation-support team from the National Center for Cardiovascular Diseases and CRO Company led training sessions on the latest GCP update and data management process to enable FUTURE II Trial investigators to have a better understanding in principles and methodology of randomization to reduce allocation bias, so as to ensure data reliability, integrity and continuity.
Firesorb® clinical trials comprise of FUTURE I, FUTURE II and FUTURE III. The first patient of Firesorb® FUTURE I was enrolled in last January in Fuwai Hospital of Chinese Academy of Medical Sciences, and the six-month angiographic results of FUTURE I was released during 2016 Transcatheter Cardiovascular Therapeutics ("TCT") in October. In the Investigator Meeting, Professor Bo Xu shared the six-month angiographic results of FUTURE I with the attendees and analyzed some clinical cases. The six-month angiographic findings of FUTURE I study fully demonstrated Firesorb®'s safety and efficacy in preliminary clinical applications, as it shows that there are no any events of devices related clinical endpoints - the rate of cardiac death, target vessel myocardial infarction, target lesions revascularization and stent thrombosis are all zero. The six-month in-segment late lumen loss is 0.13mm. Its 12-month angiographic findings will be released in this year's China Interventional Therapeutics ("CIT") from March 30 to April 2. Another pivotal study of Firesorb® - 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.
Firesorb ® is the fourth-generation coronary stent system in-house developed by MicroPort®. It is applicable 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, without 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 revolutionized 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, Firesorb® was recently granted by China Food and Drug Administration ("CFDA") the Green Channel status, 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.