Double Milestone: Kossel Medtech Secures Two Class III Medical Device Approvals in China
Kossel
Vascular Interventional Device Manufacturer and R&D Developer
Recently, Medpark enterprises in Jiangsu Medical Device Technology ParkKossel's self-developed Octoparms® II Caval Filter, and its subsidiary Mixin Medical's Seledora® Coronary Spur Balloon, approved by the National Medical Products Administration (NMPA) for marketing with a Class III medical device registration certificate.
Octoparms® II Vena Cava Filter
Three Core Advantages Upgrade
Octoparms® II Vena Cava Filter (China Medical Device Registration No. 20253130576)
01 Filter StabilityUpgrade
➰ Smooth Transition of Recycling Hooks, reduce delivery resistance
➰ Balanced Arm Raising and Widening, Enhance Long-Term Stability
➰New Anchor Hook Design`, Anti-displacement, Anti-penetration`
➰ Diamond-shaped Filter Mesh, effectively intercepting blood clots of 4mm and above
02 Filter SpecificationsUpgrade
03 Delivery SystemUpgrade
➰ Detachable Interlocking ArmDesign, ImplementationControlled Release via the Neck
➰ Interval 30mmDouble Contrast Ring, assisting in measuring the diameter of the inferior vena cava
➰ Intrathecal Lined Spring Coil, EnhancedSupport and Flexural Resistance, Establish a Stable Access
➰ Delivery SheathDistal Thread Locking, Prevent Displacement, Easy and Worry-free Access
Octoparms® Caval Filter is a clinically verified, high-performance Chinese-made umbrella filter. Since its launch, it has been recognized by nearly 2,000 medical centers in China, benefiting tens of thousands of patients.
Derived from clinical practice and serving clinical needs, the Octoparms® II Vena Cava Filter, an upgraded version of the Octoparms® Vena Cava Filter, will achieve broader application and recognition, benefiting more patients.
Seledora® Coronary Cutting Balloon (China Medical Device Registration No. 20253030586)
The approval and market launch of Seledora® Coronary Cutting Balloon marks another breakthrough for Kossel in the full-cycle management of "precise pre-treatment and vascular function restoration" in coronary intervention.
Kossel was founded in November 2013 and is located in the Jiangsu Medical Device Technology Park, Medpark. It is a platform enterprise with comprehensive R&D, production, and commercialization capabilities for vascular interventional devices, dedicated to providing systematic solutions for clinical use.
Kossel's multi-division and group-oriented operations see the parent company focusing on building a one-stop treatment system in the peripheral intervention field. Subsidiary Haiyu Xincheng is dedicated to the electrophysiology field, providing comprehensive solutions for treating tachyarrhythmia. Subsidiary Mixin Medical concentrates on the development of products in the coronary intervention field as well as the localization of overseas products and technologies. Subsidiary Haiwang Medical is committed to the research and development of core raw materials that address critical bottlenecks. Kossel is actively promoting its "Going Global" strategy and took a solid step towards globalization by acquiring Micell Ireland at the end of 2021.
Jiangsu Medical Device Technology Industrial Park Medpark, as the main base for the development of the medical device and biopharmaceutical industries in Suzhou New District, has currently gathered related enterprises.Over 1,400, holding Class II and III medical device registration certificatesOver 1,500 pieces，12 ModelsInnovative products enter the "green channel" for China's innovative medical devices, forming a significant industrial cluster effect;National Medical Products Administration's Key Laboratory for Intelligent Medical Device Research and Evaluation, Suzhou Institute of Biomedical Engineering, Chinese Academy of SciencesA batch of professional scientific research institute platforms; construct"2+5+N" Service System, Build"One Enterprise, One Group" Service Model, integrating high-performance services throughout the entire process of enterprise development; establishing a first-class medical device industry fund "reservoir", and making every effort to cultivate innovative enterprises for listing.
NextJiangsu Medical Device Technology Park Medpark will continue to optimize industrial support, refine corporate services, and fully promote the high-quality development of the medical device and healthcare industry. It aims to inject strong momentum into the upgrading of the medical industry in Suzhou and even throughout China, establishing the top brand (Medpark) in China's medical device industry and creating a billion-level medical device industrial base.
