MicroPort® Firesorb® Pivotal Study (FUTURE III) Holds National Investigator Kick-off Meeting in Beijing

Beijing, China - On October12, 2019, FUTURE-III, a pivotal Study for Firesorb® Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb®"), which is the world's second-generation bioresorbable scaffold system developed by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") independently, held the national investigator kick-off meeting during the 30th edition of Great Wall International Congress of Cardiology in Beijing, China. The meeting brought together 100 investigators and experts of related departments from 62 clinical centers in China.

 

The pre-marketing clinical studies for Firesorb® are composed of FUTURE-I, FUTURE-II and FUTURE-III trials. All the three trials have Academician Runlin Gao from Fuwai Hospital of Chinese Academy of Medical Sciences as principal investigator, with Professor Bo Xu from the same hospital as joint principal investigator. The FUTURE-III trial is a prospective, multi-center and single arm objective performance criteria (OPC) study, which will enroll at least 985 subjects in the regular specification group and 103 subjects in the long scaffold group. The primary endpoint of the FUTURE-III trial is target lesion failure rate at 12 months, and the secondary endpoints include device/lesion success rate, target lesion/target vessel revascularization and scaffold thrombosis. All the subjects will be followed for 60 months after enrollments.

 

MicroPort® Vice President, Clinical Science & Medical Affairs, and Dean of Knowledge & Action Medical Training Institute Dr. Ming Zheng presided over the meeting. Professor Bo Xu from Fuwai Hospital of Chinese Academy of Medical Sciences shared the features of the Firesorb® scaffold and the 36-month follow-up data from the FUTURE-I (FIM) trial. Firesorb® is a second-generation bioresorbable scaffold with a 100-120 micron thick scaffold wall that is far thinner than that of the first-generation bioresorbale scaffold of 150-180 micron thick. Test results showed that the radial support strength of Firesorb® is better than that of the first-generation bioresorbale scaffold. The thin wall design contributes to rapid endothelialization after implantation to reduce post-operative thrombosis risk, shorten resorption time and decrease late-stage biological risks. In addition, the scaffold inherits the target eluting technology of Firehawk® where the drug is loaded on the abluminal side of the strut to reduce overall dose and avoid the late-stage risk of adverse events that are caused by long-term residue of massive drug in human body. The FUTURE-I (FIM) trial’s 36-month follow-up data indicated that the primary endpoint, target lesion failure rate was 0%, and the incidence of second endpoints were also very low, with 2.2% of PoCE (composite of all death, all myocardial infarction and any revascularization), 0% of all death, target vessel myocardial infarction, and in-scaffold thrombosis. The 36-month OCT follow-up results were obtained after examination of 45 subjects with over 40,000 struts at nearly 4,000 cross-sections, , which preliminarily confirmed the safety and efficacy of Firesorb®.

 

Dr. Ming Zheng commented, “MicroPort® is the first domestic company that independently develops and produces PCI devices in China. The data from TARGET AC, the European multi-center randomized-controlled study on the Group’s core innovative product of Firehawk®, was published in 2018 and confirmed the extraordinary safety and efficacy of Firehawk®. The primary endpoint data at 12 months were published in the leading medical journal the Lancet.”

 

Academician Runlin Gao shared the design of the FUTURE series study and the protocol for the FUTURE-III study. He also had in-depth discussions with the attending investigators on the design principles, inclusion and exclusion criteria, and set out the requirements on the operations of the plan, standards on prescription and consent of the subjects. He endorsed the smooth advancement of the FUTURE-I and FUTURE-II trials and expected early completion of the FUTURE-III trial with sucess.

 

Professor Lei Song from Fuwai Hospital of Chinese Academy of Medical Sciences spoke of the optimal implantation technique for resorbable stent, i.e. PSP strategy and procedure, including good lesion preparation, selection of appropriate scaffold sizes in accordance with angiography, and the necessary post-dilation after scaffold implantation. The attendees from MicroPort® introduced the operations and execution plan of the upcoming trial and particularly explained the requirements on quality and supervision plan for the clinical centers. The FUTURE-III trial is planned to complete the first enrollment in December 2019 and complete the remainder in June 2021.

 

Firesorb® is a bioresorbable scaffold system developed by MicroPort® independently for the patients with ischemic heart diseases with de novo coronary artery lesions. Compared to conventional permanent metal stents, the bioresorbable scaffolds are made of special completely degradable materials that are expected to be fully absorbed by the human body through degradation after implantation, and then restore patients’ vessel structure and function back to normal physiological condition. Currently, Firesorb® has been grated entry into the Special Review and Approval for Innovative Medical Devices with the National Medical Products Administration (NMPA) of China (the “Green Path”), which will effectively optimize the registration path for Firesorb® and significantly expedite its approval progress in China. In the future, with the approval for Firesorb®, MicroPort® will provide a more comprehensive integrated solution in the treatment of coronary artery diseases, and benefit more patients by offering more choices to both patients and physicians.