Shanghai, China — Recently, Shanghai Microport Medical (Group) Co., Ltd (MicroPort®) recently participated in the 15th Oriental Congress of Cardiology (OCC 2021) to present the key imaging and clinical results of the FUTURE-II trial – a pivotal study of the Firesorb® Bioresorbable Rapamycin Targeted Eluting Coronary Scaffold System ("Firesorb®"), a second-generation bioresorbable vascular stent system developed by MicroPort®. The results were presented by co-principal investigator, Professor Bo Xu of Fuwai Hospital of the Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases.
The FUTURE-II trial is a prospective, multicenter, non-inferiority designed randomized controlled trial, which aims to compare the safety and effectiveness of Firesorb®, the second-generation bioresorbable eluting stent, with the XIENCE cobalt-chromium everolimus-eluting stent (EES). It was carried out at 28 medical centers across China and involved 433 patients with primary obstructive coronary atherosclerotic heart disease. The one-year follow-up results show that Firesorb® is not inferior to EES based off of the primary endpoint of angiographic in-segment late lumen loss at one year and the major secondary endpoint of one-year proportion of covered struts evaluated by optical coherence tomography (OCT).
In particular, Prof. Bo Xu noted at the congress that the one-year data from the FUTURE-II trial demonstrated the effectiveness of the thinner strut design of Firesorb®. The Firesorb® group showed a significant advantage over the control group in terms of incomplete apposition at one-year OCT. The mean stent wall coverage thickness in the Firesorb® group, as well as the stent wall protrusion in the immediate post-operative period, was lower in the control group. Given post-dilatation pressure at 16 atm, Firesorb® is to some extent embeddable in the vessel wall, which makes it outperform the first-generation of fully bioresorbable vascular scaffold systems while also providing the basis to support potential late benefits of thin struts.
In addition, one-year clinical follow-up showed no significant difference in the incidence of target lesion failure (TLF) between the two groups. The incidence of patient-oriented composite endpoint (PoCE, defined as all-cause death, myocardial infarction and unplanned revascularization) at one-year of follow-up was similar and, no significant difference was found in the incidence of TLF and PoCE at 393 days between the two. There were no significant differences in composite endpoint components and no device-related thrombotic events occurred in either group.
Based on the results of these trials, Prof. Bo Xu recognized the performance of the Firesorb® scaffold and emphasized that the trial further demonstrated the role of the ‘PSP’ principle in bioresorbable stent implantation – prepare the lesion, size appropriately, and post-dilate.
In the future, with the official market approval of Firesorb®, MicroPort® will be able to provide a total medical solution for coronary artery disease, providing patients and doctors with more options for the benefit of more patients.
Firesorb® is a bioresorbable stent system developed by MicroPort® for patients with ischemic heart disease caused by primary coronary lesions. Unlike traditional permanent metal stents, bioresorbable stents are made of fully biodegradable materials, which are expected to biodegrade and be completely absorbed by the body within a period of time after implantation, thereby restoring the patient’s vascular structure and function to its natural physiological state. Currently, Firesorb® has been granted access to the special approval process for innovative medical devices by the National Medical Products Administration (NMPA) of China, also known as the ‘Green Path’, with numerous clinical studies currently underway. The FUTURE series clinical trials are expected to continuing following all patients enrolled for up to five years.
About Shanghai Microport Medical (Group) Co., Ltd
Shanghai MicroPort Medical Group Co., Ltd. (MicroPort®) is a subsidiary of MicroPort Scientific Corporation (00853.HK). MicroPort® has grown over the years to become one of the leading manufacturers of medical devices. Its products cover a wide range of medical fields, including cardio rhythm management, orthopedic devices, vascular intervention, surgical management, and more. 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.