Achieva Medical’s Syphonet® Stent Retriever Receives NMPA Approval for Commercialization

The Syphonet® Stent Retriever (formerly named as Shenyi® in English), a technologically advanced product developed by Achieva Medical Limited (“Achieva”), a wholly-owned subsidiary of the Company, is approved by the National Medical Products Administration (the “NMPA”) on February 11, 2022. The registration approval marks the further expansion of Achieva’s product portfolio for acute ischemic stroke treatment.

The pre-marketing clinical trial of the Syphonet® Stent Retriever, a prospective, multi-central, randomized controlled, and Non-inferiority trail, was completed by Dr. Jianmin Liu team from Changhai Hospital of Shanghai and other 11 advanced stroke centers. The conclusion of this trial shows that the safety and efficacy performance of the Syphonet® Stent Retriever is similar to the widely used stent retriever on the market.

The product’s unique design features a capture basket at the distal end, which can effectively prevent the thrombus fragments from dislodging into the blood stream, thereby improving the capture of the thrombus. The stent is also designed with optimized radial force to maintain the integrity of the lumen even in curved vessels. Radiopaque wires on the stent and a radiopaque marker on the distal end allow for a fluoroscopic visualization of the entire retriever, facilitating physicians with better visual guidance. The Syphonet® Stent Retriever has various specifications, all compatible with 0.017-inch micro-catheter. The compatibility feature will improve the success rate of deployment and reduce procedure time.

Achieva now provides the Syphonet® Stent Retriever, Tethys® Intermediate Catheter, Presgo® Micro Guidewire and Presgo® Micro Catheter for acute ischemic stroke treatment. With the successive launch of Tethys AS® Aspiration Catheter and Fluxcap® Balloon Guiding Catheter this year, Achieva will be able to provide physicians a fully integrated solution for acute ischemic stroke patients. Physicians can rely on Achieva’s product combinations for different procedures, based on the clinical manifestations of patients.