Three Innovative Medical Devices Approved in China in June, Including Inari Medical's Pulmonary Thrombectomy System

　　【Pharmaceutical Network Product InformationAccording to a June 23 announcement on the website of the National Medical Products Administration, another innovative medical device has been approved for marketing. This innovative device is Innare Medical Co., Ltd.'s "Pulmonary Artery Thrombectomy System." It is reported that this is the second innovative device from Innare Medical Co., Ltd. to be approved for marketing in China.
 

Data shows that the innovative "Pulmonary Artery Thrombectomy System" approved for marketing this time consists of the FlowTriever thrombectomy stent, Triever aspiration catheter, FlowSaver blood recovery device, large-bore aspiration syringe, and FlowStasis adjustable venous compression hemostasis device. The FlowTriever thrombectomy stent adopts a "self-expanding disc" design to capture thrombi, the Triever aspiration catheter features a "large-bore" design for rapid thrombus aspiration, and the FlowSaver blood recovery device is used for filtering and recovering the contents aspirated by the large-bore aspiration syringe.
 

Moreover, on March 14, 2025, Innary Medical's innovative peripheral venous thrombectomy stent system was also approved for marketing in China. The product consists of the ClotTriever thrombectomy sheath and the ClotTriever thrombectomy stent; the thrombectomy sheath components include the sheath, dilator, pre-dilator, loading tool, and large-bore suction syringe. This product is suitable for catheter-directed thrombectomy treatment of deep vein thrombosis (DVT) in the lower extremities under the following conditions: (1) Acute iliac-femoral and femoral-popliteal vein DVT; (2) Subacute iliac-femoral vein DVT.
 

Including the aforementioned two products, as of now, 357 innovative medical devices have been approved for marketing in China. In June this year, apart from "Inari Medical's Pulmonary Artery Thrombectomy System," two other innovative devices were approved, namely Medtronic's extravascular implantable cardioverter defibrillator and Sinoflow Medical Technology Co., Ltd.'s digital PCR analyzer.
 

Data shows that the innovative extravascular implantable cardioverter defibrillator product developed by Medtronic consists of an implantable cardioverter defibrillator and a torque wrench. When combined with extravascular implantable cardiac defibrillation leads, it forms an extravascular implantable cardioverter defibrillator system, which is placed under the sternum to provide automatic treatment for antitachycardia pacing, cardioversion, and defibrillation in patients at significant risk of life-threatening ventricular tachycardia. The device offers both cardiac and extravascular antitachycardia pacing as well as bradycardia prevention pacing functions. Compared to intravenous implantable cardioverter defibrillator systems, it effectively reduces complications associated with transvenous leads and better meets the clinical needs of patients requiring 1.5T and 3.0T magnetic resonance imaging.
 

Suzhou Snafu Medical Technology Co., Ltd.'s innovative digital PCR analyzer is composed of a temperature control module, droplet generation module, optical module, motion control module, power module, and software. It is mainly used for the quantitative detection of ribonucleic acid from leukemia fusion genes in human blood samples. Based on the principle of digital PCR detection, the product uses injection vibration technology to divide the reaction system into tens of thousands of droplets, each of which can independently complete the PCR amplification reaction. After the PCR amplification reaction, droplets containing target nucleic acid molecules will produce fluorescence, while those without target nucleic acid molecules will not. By detecting the fluorescence signal of each droplet, the copy number of the target gene fragment within the entire reaction system is calculated, enabling the quantitative detection of leukemia fusion genes. This product is used in conjunction with testing reagents to provide more accurate diagnostic criteria for leukemia, benefiting more patients.
 

The industry believes that the approval and market entry of these innovative medical devices fully demonstrate the innovation vitality in the field of medical devices. They will provide more effective means for the treatment of related diseases, bring more health protection to patients, and at the same time, will push China's medical standards to new heights.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.