Shanghai, China, 27 September 2021 - Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort®), has completed the final subject enrollment for the pivotal FUTURE-III trial of the Firesorb® Bioresorbable Rapamycin Targeted Eluting Coronary Stent System (Firesorb®) – the world’s next-generation, fully bioresorbable vascular scaffold system. This milestone marks the completion of the enrollment of all 985 subjects since the first subject enrollment on December 3, 2020.
FUTURE-III is a prospective, multicenter, single-arm target value premarket clinical study in line with regulatory requirements, which is currently underway in over 70 hospitals across China. The primary endpoint of FUTURE-III is target lesion failure at 1 year. Secondary endpoints include device/lesion success rate, target lesion/target vessel revascularization and stent thrombosis. Subjects will be followed for 60 consecutive months after enrollment.
Ming Zheng, Senior Vice President of Clinical Science at MicroPort®, stated, “The safety and efficacy of Firesorb® in the treatment of primary coronary artery disease is further confirmed by some of the results from previously completed FUTURE trials, which showed rapid early vascular healing, very low incidence of late adverse events and no determined possible device thrombosis using the Firesorb® stent. We look forward to the primary endpoint results of the FUTURE-III project soon, as they will provide even more valuable medical evidence for the clinical practice of coronary intervention.”
Firesorb® marks a new generation of bioresorbable stents made of special materials that are fully biodegradable. In contrast to traditional permanent stents that leave a stiff metal scaffold in blood vessels, bioresorbable stents are completely absorbed by the body within a certain period of time after implantation, thereby restoring the patient’s natural vascular structure and function. The scaffold wall thickness of Firesorb® is only 100-120 micron, which is significantly thinner than that of the first-generation product at 150-180 micron. 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.
The pre-market clinical trials for Firesorb® include FUTURE-I (first-in-man trial), FUTURE-II (randomized controlled trial) and FUTURE-III (OPC historical control study). Currently, all FUTURE trials have completed subject enrollment and the project team will continuously follow up with all subjects to ensure the quality of clinical data.
In the FUTURE II trial, the safety and efficacy of Firesorb® were compared with the XIENCE cobalt-chromium everolimus-eluting stent by Abbott. MicroPort® released the major one-year angiographic and clinical results of the FUTURE II trial at the Congress of the European Association of Percutaneous Cardiovascular Interventions 2021 (EuroPCR2021) held in May 2021.
Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort®), is a subsidiary of MicroPort Scientific Corporation (Group) Co., Ltd. (stock code: 00853.HK). As a leader in high-end innovative medical solutions, MicroPort® places emphasis on the human dimension while integrating the pursuit of perfection and innovation into the corporate DNA. In the future, MicroPort® will continue to pursue an innovative, people-centered culture to provide patients and physicians around the world with innovative high-end medical devices and integrated solutions.