First Domestically Produced Negative Pressure Mechanical Thrombus Aspiration Catheter Approved. Recently, Genesis MedTech Group announced that its “Genclear Thrombus Aspiration Catheter” has officially received approval from the National Medical Products Administration (NMPA) for market launch. This product is the first domestically manufactured negative pressure mechanical thrombus aspiration catheter to be approved in China.
The “Genclear Thrombus Aspiration Catheter” was developed in collaboration between Genesis MedTech and U.S.-based Penumbra, Inc. Genesis MedTech obtained authorization from Penumbra to complete the product’s development, production, and registration in China using a “one-to-one” technology transfer approach, ensuring identical raw materials, technology, and manufacturing processes.
Clinical Significance in Acute Myocardial Infarction
In patients with acute myocardial infarction, coronary artery thrombosis can obstruct blood flow, leading to myocardial ischemia or even necrosis. The mechanical thrombus aspiration catheter enables physicians to rapidly remove thrombi before balloon dilation or stent implantation, restoring blood flow and reducing myocardial damage. This technology is particularly beneficial for patients with high thrombus burden, significantly lowering the incidence of no-reflow or slow-flow phenomena.
Enhanced Design and Performance
The “Genclear Thrombus Aspiration Catheter” utilizes a negative pressure suction pump for mechanical thrombus extraction, greatly improving efficiency. The catheter is manufactured using hypotube cutting technology, and its tip design has been optimized for smooth navigation through tortuous vessels, minimizing the risk of vascular endothelial injury. Its large inner lumen ensures high-flow suction capacity while reducing the likelihood of catheter blockage.
Strong Clinical Evidence
The technology-transferred counterpart of the “Genclear Thrombus Aspiration Catheter” has been supported by extensive overseas clinical studies, demonstrating that continuous negative pressure thrombus aspiration is safe for clearing high thrombus burden. Additionally, it reduces distal embolism rates and improves myocardial perfusion [1], [2]. Following the domestic product launch, Genesis MedTech plans to conduct post-market studies in China to further validate its efficacy and safety.
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