Shanghai, China – Shanghai MicroPort Medical (Group) Co ("MicroPort®") has completed the patient enrollment for the perspective, single group observation, First-in-Man ("FIM") clinical trial of evaluating the safety and efficacy of Firesorb™ Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb™") in the treatment of coronary heart diseases. A total of 45 patients are enrolled in the trial after it was launched on January 18.
The preliminary result of the clinical trial shows that the enrolled patients are suitable for the operation, and the implantation technique conforms to the standard with proper scaffold size selection, full pre-dilation that makes the scaffold easily reach the lesion, high percentage post-dilation, and proper endovascular imaging guidance.
Professor Bo Xu of the Fuwai Hospital said, as the first second-generation bioresorbable scaffold that has completed patient enrollment for FIM clinical trial in the world, Firesorb™'s primary advantages lie in its ultra-thin wall and target eluting design. The completion of patient enrollment has provided the first evidence of Firesorb™'s safety and efficacy.
Once the enrollment is completed, clinical follow-up will be performed in the 45 patients in one month, 6 month, one year, two years, three years, four years and five years after scaffold implantation. Currently, MicroPort® is preparing to carry out a large scale, multi-center clinical trial of Firesorb™.
"The completion of the patient enrollment of the FIM clinical trial lays a great foundation for the following clinical studies of this cardiovascular device," said Dr. Qiyi Luo, Chief Technology Officer of MicroPort®. "We hope the results of these clinical studies would pave the way for Firesorb™'s market launch in China, so as to offer more solutions to patients with coronary artery diseases."