gp (hk) obtains medical device registration certificate for the first drug coated balloon specified for vascular access for hemodialysis in the prc market
2020-04-28 hit：8 information sources：grand pharma
(april 20, 2020, hong kong) china grand pharmaceutical and healthcare holdings limited (“gp (hk)” or the “company”, together with its subsidiaries, the “group”, stock code: 00512) is pleased to announce that, the group and “cardionovum” gmbh (“cardionovum”, an associated company located in germany) co-developed a drug coating balloon product “paclitaxel releasing hemodialysis shunt balloon dilatation catheter” (product brand name: aperto otw) (“aperto otw”), which is the first in the prc market specified for patients on hemodialysis and suffering shunt restenosis, has been recently granted the medical device registration certificate by national medical products administration of prc. the group will be responsible for the promotion and distribution of such product in china.
aperto otw is the first drug coated balloon product in the china market specified for arteriovenous fistulas (“avf”) stenosis. the balloon catheter contains the characteristics of both drug application and high pressure. it can work under high pressure, and thus can improve the success rate and reduce the stenosis at the lesions. it applies exclusive safepax coating technology which reduces the chance of washing-off the drug coated on the balloon surface by blood during the delivery towards the target sites, and thus can guarantee the sufficiency of drugs being delivered to lesions. it can also inhibit intimal hyperplasia at the lesions and prolong the patency. in comparison with ordinary high-pressure balloon without drug coating, aperto otw has shown a bright prospect for clinical application in the treatment of avp stenosis, and it is expected to be a better treatment option for shunt restenosis in arteriovenous fistulas.
the group used 3 years to complete the forward-looking, multi-center and randomized controlled clinical study for applying aperto otw in the treatment for shunt restenosis in arteriovenous fistulas (the “aperto avf china study”). it proved the safety of applying aperto otw in avf stenosis and better efficiency than ordinary high-pressure balloon. the results were firstly published in the “charing cross symposium” held in london, uk in 2019, and widely recognized by experts in china. being an innovative product for intraluminal treatment of dialysis access, after getting approved for commercialization, aperto otw will be the first and the only drug coated product specialized for vascular access. and it is able to be one of the representative treatment options for renal disease dialysis access, and has a significant clinical value and bright market prospect.
the board of china grand pharmaceutical and healthcare holdings limited, commented: “aperto otw has obtained the medical device registration certificate, representing the group is qualified to sell or distribute such product in china. it may enrich the product line and strengthen the competitive edges of the group in the vascular intervention aspect. the group will strive for the commercialization of such product, in order to enrich the product pool of the medical devices of the group and enhance the market competitiveness.”
“meanwhile, restore, being one of another two innovative self-developed drug-eluting balloon products, already obtained the medical device registration certificate in china in september 2019. the clinical study and registration of another peripheral vascular intervention product legflow is running smoothly, and it is expected to further enrich our product pipeline in the field of vascular intervention once approved for commercialization. in the future, the group will continue to explore in the medical device aspects, especially those innovative and proprietary products, in order to provide more clinical options to doctors and patients, and meanwhile enhance the market competitiveness of the group and bring considerable returns to shareholders and investors.”