China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced a significant milestone with the enrollment of the first patient in a prospective, multi-center, randomized controlled clinical study. The study is designed to assess the efficacy and safety of Blue Sail Medical’s rapamycin-coated balloon dilation catheter for arteriovenous fistula in autologous arteriovenous fistula in hemodialysis patients with stenosis or blockage of the dialysis pathway in China.
Addressing Limitations of Plain Balloon Angioplasty
While plain balloon angioplasty (PBA) has long been considered an effective method for treating venous stenosis within the AVF dialysis pathway, its application has been somewhat limited due to short-term restenosis post-surgery. This issue leads to increased interventions and thrombotic events. In contrast, drug-coated balloon (DCB) products, which have gained widespread attention in recent years, can effectively inhibit endometrial hyperplasia and maintain the long-term patency of the arteriovenous fistula pathway.
Innovative Features of the Product
Blue Sail Medical’s in-house developed product is the first of its kind in China, featuring proprietary rapamycin drug LA9. This makes it safer in terms of cytotoxicity compared to paclitaxel. Rapamycin, an immunosuppressive agent widely used in anti-rejection therapy after kidney transplantation, further confirms its safety profile in treating arteriovenous fistula stenosis in end-stage kidney disease patients.
Clinical Trial Significance
The initiation of this clinical trial marks a significant step forward in the treatment of arteriovenous fistula stenosis. By leveraging the unique properties of rapamycin, Blue Sail Medical aims to extend the service life of the dialysis pathway, offering a potentially more effective and safer treatment option for hemodialysis patients.-Fineline Info & Tech
