MicroPort® Enrolls First Patient in PROMISE-BIF Study to Investigate the Rapamycin Coronary Balloon Catheter for the Treatment of De Novo Coronary Artery Bifurcation Lesions

Shanghai, China, 11 March 2022 — Shanghai MicroPort Medical (Group) Co., Ltd. (MicroPort®) has announced the enrollment of the first patient in its PROMISE-BIF study, a pre-marketing clinical study of an independently developed coronary rapamycin drug balloon catheter for the treatment of de novo coronary artery bifurcation lesions. The clinical study was initiated by MicroPort® and led by principal investigator Yaling Han.

The PROMISE-BIF study is a prospective, multicenter, randomized controlled trial designed to evaluate the safety and efficacy of the rapamycin coronary balloon catheter for the treatment of de novo coronary artery bifurcation lesions. The rapamycin coronary balloon catheter features a unique polymer/excipient-free design that maintains tissue concentration for more than 28 days, which can reduce the likelihood of inflammatory reactions in patients induced by the polymer.

The study plans to enroll 236 subjects with de novo coronary bifurcation lesions, with the primary endpoint being lumen diameter stenosis of the target lesion side branch at nine months. Secondary endpoints include the nine-month in-segment late lumen loss of the target lesion branch vessel, device/lesion success rate, revascularization, and stent thrombosis. Subjects enrolled in the trial will be followed for two years. It is hoped that the PROMISE-BIF research and the subsequent launch of the rapamycin coronary balloon catheter in China will offer real clinical benefit to coronary artery disease patients.

MicroPort® remains committed to its brand philosophy “The Patient Always Comes First”, and is conducting a number of clinical research programs around the world. These programmes will help MicroPort®’s continuous innovation by providing clinical data to support the expansion of its cardiovascular interventional product portfolio, in turn enabling them to deliver more and improved treatmentment options for patients with coronary artery disease.

About Shanghai Microport Medical (Group) Co., Ltd.
Shanghai MicroPort Medical (Group) Co., Ltd. is a subsidiary of MicroPort Scientific Corporation (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 with higher-quality, innovative high-end medical devices and integrated solutions.