The drug-eluting balloon catheter, independently developed by a Dalian-based pharmaceutical company, recently obtained a product registration certificate from the China Food and Drug Administration.
According to the official website of the CFDA, it is the world's first drug-eluting balloon catheter approved for use in coronary bifurcation, offering a new therapeutic solution for the treatment of bifurcation lesions that are urgently needed.
"The product is an RX-type balloon dilatation catheter. The balloon surface has a drug coating. It can be used for the expansion of the primary coronary artery bifurcation stenosis," according to a notice named "Drug-eluting balloons catheter approved to launch" published at www.sfda.gov.cn Nov 28.
Dong Heyan, chairman and chief technology officer of Yinyi (Liaoning) Biotech Co Ltd, said the product can replace heart stents, which are currently the major clinical treatment of coronary heart disease.
After completing the treatment of diseased vessels, the drug balloon could withdraw from the body without leaving any remains, Dong said.
"More and more clinicians and patients are choosing interventional therapy with no implantation. The Bingo drug-eluting balloon catheter is a scientific practice of this concept," she added.