Good News: SceinTech’s biodegradable occlude interventional delivery system obtained Class III Medical Device Registration Certificate

      On June 19, 2023, the G-cruiser® Interventional Delivery System for Biodegradable Occluder" formally obtained the Registration Certificate for Class III devices  (Registration No.: 20233030819) approved by the National Medical Products Administration (NMPA), which was independently developed by Shanghai Shape Memory Alloy Co., Ltd., a wholly owned subsidiary of Lepu ScienTech Medical Technology (Shanghai) Co., Ltd.). This product facilitates the delivery of biodegradable occluders to the diseased area within the heart, and provides doctors with more alternatives for creating personalized treatment regimens.

(Source: National Medical Products Administration Electronic Certificate Verification Center)

Biodegradable upgrade, Accurate access

        Due to the rapid development and widespread clinical use of fully biodegradable occluders, traditional occluder delivery systems are unable to meet the delivery requirements for such biodegradable occluders during procedures. Therefore, ScienTech Medical independently developed the G-cruiser® Interventional Delivery System for Biodegradable Occluder. The unique aspect of this product, which compare to conventional occluder delivery systems, is its pusher device design (patent publication no.: CN115581488A - Biodegradable occluder and pusher device). An "internal thread" encircling screw mechanism is used on the steel cable head of the pusher to ensure a secure connection with the occluder and to facilitate easy delivery and withdrawal. The coated design of the steel cable makes it move smoother, which prevent airlock issues during delivery and ensuring safe delivery. Additionally, to fulfill the unique delivery requirements for biodegradable ASD, PFO, and VSD occluders for different interventional paths, this system offers various length and bend options, which enhance versatility for clinical applications. Moreover, its functioning is also similar to that of conventional metal occluder delivery sheaths so as to effectively shorten the learning curve for doctors, and make it simpler to use and promote.

Continuous Innovation, Endless Development

       The successful approval and market launch of the G-cruiser® Interventional Delivery System for Biodegradable Occluder enrich ScienTech Medical’s product line in the field of biodegradable technologies for congenital heart diseases and also improve interventional delivery systems currently in clinical use.

        In future, ScienTech Medical will continue to drive innovation-led development, invest in R&D, and constantly advance medical technology to enhance its capabilities. It will transform achivement of high-tech R&D into products that serve human health, cater to varied clinical requirements and provide better health security for patients.