Two Innovative Medical Devices Have Been Approved in Only Three Days
On July 30 and August 2, 2021, NMPA approved the registration of innovative products Intracranial Drug-eluting Stent System and Calculation Software of Coronary CT Fractional Flow Reserve respectively.
The Intracranial Drug-eluting Stent System includes drug coated stent and rapid exchange balloon catheter delivery system. The drug coated stent was based on 316L stainless steel stent, and the surface was coated with bottom coating and polymer degradable coating containing rapamycin.
The product is used for intracranial atherosclerotic stenosis. The reference vessel diameter is 2.25 ~ 4.0mm, and the applicable lesion length is less than or equal to 15mm. Rapamycin in this product can inhibit the excessive proliferation of vascular smooth muscle cells and reduce the incidence of in stent restenosis, so as to reduce the risk of long-term recurrent stroke. At present, there are no predicates on the market at home and abroad.
Calculation Software of Coronary CT Fractional Flow Reserve (FFR) is composed of software installation CD. The functional modules include: coronary artery extraction module, image cutting module, FFR display module and hemodynamic calculation FFR module. The product obtains the CT FFR based on the coronary CT vascular image. Before the coronary angiography, it assists the training of qualified medical technicians to evaluate the functional myocardial ischemia symptoms of patients with stable coronary heart disease. This is also the second Calculation Software of Coronary CT Fractional Flow Reserve registered in China after April 14, 2021.
China encourages innovative medical device with lots of bonuses policy launched. Particularly in Hainan Medical Tourism Pilot Zone, special benefits can help manufactures to expedite their registration in China market entry. IMD has seasoned staff in the registration of innovative medical devices. If you are interest in the innovative medical device in China, you can contact us (info@inspirativemed.com) to get a list of NMPA approved innovative medical devices for free.
