BISORB®Drug-Eluting Sinus Absorbable Stent System Approved for Registration in the Philippines
Date：2024-06-12 17:27:10
Certification Announcement
BISORB®Drug-Eluting Sinus Absorbable Stent System Approved for Registration in the Philippines
Puyi (Shanghai) Biotechnology Co., Ltd. (hereinafter referred to as "the company") obtained the approval for the market launch of the BISORB®Drug-Eluting Sinus Absorbable Stent System in the Philippines on March 7, 2023. The registered name of the product is "BISORB® Drug-Eluting Sinus Absorbable Stent System." This product has been reviewed by the PFDA and meets the market access requirements.
The aforementioned product is suitable for patients with chronic rhinosinusitis (CRS) undergoing endoscopic sinus surgery (ESS). It is mainly used for intraoperative and postoperative implantation to support and separate the wound surface, fix and repair the mucosal flap, and slowly release hormones to control edema, prevent adhesion, maintain unobstructed drainage, continuously target inflammation, and promote healing. The fully biodegradable sinus drug-eluting stent system includes: stent and delivery system. The product is sterilized using electron beam irradiation. This product is primarily used to prevent nasal mucosal adhesion.
The approval of this product by the PFDA for market launch will benefit more local patients in clinical applications, providing a solid foundation for the company to further expand its presence in the Asian overseas market and open up a new landscape in the Southeast Asian regional market.
