Hangzhou WeQiang Medical's Innovative Iliac Vein Stent System Receives NMPA Approval
Wei Qiang Medical
Vascular Interventional Device R&D and Manufacturer
On July 11, the National Medical Products Administration announced that it had recently approved the "Iliac Vein Stent System"Innovative Product Registration.
Image Source: NMPA Official Website
The iliac vein stent system consists of a stent and a delivery device. The stent is preloaded in the delivery device and is a self-expanding nitinol stent with tantalum as the radiopaque marker material. The delivery device consists of a sheath core, a sheath tube connector, a hemostatic valve, a handle, and a tail handle. The product is sterilized with ethylene oxide and is for single use only.Intended for use in the common iliac vein to treat non-thrombotic iliac vein compression syndrome.。
The product improves its performance to meet clinical needs through the oblique and flared proximal ends of the venous stent, an open-loop midsection design, and a segmented stent design.
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Interventional Treatment Field
Heavyweight Product Approved
Wei Qiang Medical focuses on the research, development, manufacturing, sales, and technical support of interventional medical devices. Its main products include aortic stent graft systems, intraoperative stent systems, interventional balloons, and peripheral vascular stents. To date, multiple products from Wei Qiang Medical have been approved for marketing, including the Fabulous@ Thoracic Aortic Stent and the WeFlow-Tbranch Thoracic Main Branch Stent.
Image Source: PharmCube Medical Device Data — China Marketed Device Screening System
Grency@Iliac Vein Stent System is another significant achievement obtained by Wei Qiang Medical. This productSpecifically designed for iliac vein stenosis or occlusive lesions, conforming to the anatomical shape of the iliac vein., with 9 authorized patents, received the national innovative medical device approval in 2022. Its proximal end adopts an oblique design that does not affect contralateral blood flow, and a flared opening enhances proximal wall apposition; the overall tapered gradient conforms to the natural tapering of blood vessels; the composite design of closed loops at both ends and an open loop in the middle ensures radial support while maintaining excellent flexibility.
Image Source: Wei Qiang Medical
Previously, another heavyweight product in the interventional field by Wei Qiang Medical, the "Perione Peripheral Thrombus Aspiration Catheter," also received NMPA approval for marketing. The product is suitable forRemove thrombus from peripheral vessels, including arteries and veins of the upper and lower limbs, visceral arteries and veins, superior and inferior vena cava, pulmonary artery, etc. The tip of the aspiration catheter is designed in two types: with pre-bend and without pre-bend, with a pre-bend angle of 30 degrees. The aspiration catheter, when used with a negative pressure syringe or mechanical negative pressure pump, can efficiently aspirate thrombi within peripheral blood vessels.
Image Source: Wei Qiang Medical
In addition, Wei Qiang Medical's pipeline also includes products such as the ZIPPER™ Integrated Thoracic Aortic Stent System and the WeFlow-Tbranch™ Single-Branch Detachable Thoracic Aortic Stent Graft System.
ZIPPER™ Integrated Thoracic Aortic Stent System
The main design features of the ZIPPER™ Aortic Arch Stent Graft System areIntegrated design of the main bracket, including one outer branch and two inner branches, where the outer branch enables the conversion between inner and outer branches. The stent design can adapt to the anatomical structures and complex aortic arch types of most patients; technologies such as the proximal end tapering and pre-embedded guidewire enable precise stent deployment.
WeFlow-Tbranch™ Single-Branch Detachable Thoracic Aortic Stent Graft System
This product is aSingle-branched, split-type thoracic aortic stent graft system, with its split-type and embedded branch design features, solves the challenging problem of conventional stents lacking sufficient anchoring zones for cases where dissection involves the LSA. The design characteristics of preloaded guidewires and proximal constriction before release also make the entire intraoperative procedure safer, more convenient, and ensure more accurate anchoring.
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Conclusion
Wei Qiang Medical has completed 330 related patent applications, including 110 invention patents, 55 PCT applications, and 42 overseas patents in Europe, the United States, and other regions. In addition, it is reported that the two products of Wei Qiang Medical, the modular aortic arch stent graft system and the thoracic aortic stent system, have passed the innovative medical device approval. In the future, Wei Qiang Medical's product pipeline will be more comprehensive and diverse.
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