New Technology Clinical Study of Second Generation Bioresorbable Scaffold System Completed

Beijing, China - On August 8, the New Technology Clinical Study of a Bioresorbable Scaffold System researched and developed independently by Shanghai MicroPort Medical (Group) Co ("MicroPort®") was successfully completed in Fuwai Hospital of Chinese Academy of Medical Sciences. The operation was broadcasted live in China Heart Convention ("CHC") 2015. The operation was carried out smoothly, and the patient's vital signs were stable after the operation.
The Bioresorbable Scaffold System is designed to treat patients with ischaemic heart disease caused by some coronary primary lesions. Compared with the traditional permanent metal stents, Bioresorbable Scaffold System is made of special biodegradable material, and is expected to be completely absorbed by the human body within 3 years after implantation, which will help patients recover the natural state of blood vessels. Bioresorbable Scaffold System can effectively reduce the incidence of adverse events such as late thrombosis, and it is conducive to the reconstruction of the blood vessel itself and beneficial to the diagnosis of CT and MRI. But its indications, long-term clinical effects as well as market acceptance, still need to be further verified and confirmed with large-scale studies.
MicroPort® Bioresorbable Scaffold System is currently the first and only polymer bioresorbable scaffold with strut thickness less than 150μm in China, whose strut thickness is only 100μm-125μm. Such design will facilitate the neointimalization on scaffold after implantation, so as to reduce the risk of thrombosis after operation. With less implant material, the degradation period will be shortened. Meanwhile, MicroPort® Bioresorbable Scaffold System adopts Target Eluting Technology and is the first and only bioresorbable scaffold with Target Eluting function in China. MicroPort® Bioresorbable Scaffold System only retains the drug on the abluminal surface that contacts blood vessels, reduces the drug dosage, enhances the efficiency of the treatment, and prevents a large amount of drug residual from remaining in the body for a long time. Bo Xu, Director of Intervention Catheter Department in the Fuwai Hospital, spoke highly of the product, saying it is the second-generation bioresorbable scaffold with three main features – Target Eluting, ultra-thin strut thickness and low drug dosage.
As a product that brings revolutionary change to the treatment of coronary artery disease, Bioresorbable Scaffold System has been approved in the European market in 2012, but not yet in the domestic market. After fully analyzing the advantages and disadvantages of the concept of bioresorbable scaffold, MicroPort® started to carry out the research and development work of Bioresorbable Scaffold System very carefully in 2009, and the success in the new technology clinical study preliminarily proved the safety of the product. It is expected that the product's official FIM clinical research will start in September of this year. Once the concept of bioresorbable scaffold is accepted by surgeons and patients, after its market launch MicroPort®'s Bioresorbable Scaffold System will help improve the treatment methods of coronary artery diseases together with the metal stents (Firehawk® Rapamycin Target Eluting Coronary Stent System and Firebird2™ Rapamycin-Eluting Coronary CoCr Stent System), and more options and benefits will be available to patients with coronary artery diseases.