The board (the “Board”) of directors (the “Directors”) of the Company is pleased to announce that on May 18, 2022, the Group received the approval from the National Medical Products Administration of the PRC (the “NMPA”) for the registration application of Fastunnel® Delivery Balloon Dilation Catheter, making it the Group’s thirteenth NMPA approved neurointerventional product.
Fastunnel® Delivery Balloon Dilation Catheter is an innovative product developed by Achieva Medical (“Achieva”), a wholly-owned subsidiary of the Company, designed for treating intracranial atherosclerotic disease (“ICAD”). As the first medical device in China which can realize balloon dilation and stent delivery at the same time, its unique “zero exchange” technology will usher a new era of ICAD treatment. Fastunnel® Delivery Balloon Dilation Catheter adopts an integrated design combining the features of both balloon dilation catheter and microcatheter, which can reduce the frequency of device exchange and improve the safety of the procedure. The balloon uses Pebax semi-compliant materials to achieve steady shape and safe expansion. The device is available in two sizes with lumens of 0.017 and 0.021 inches, both of which are compatible with the intracranial stent systems. Meanwhile, the stainless steel structure reinforces the entire device, and thus improves the trackability of the catheter and the deliverability of the intracranial stent systems. In addition, the 150cm delivery system is compatible with an intermediate catheter length of 135cm and below.
ICAD is one of the most common causes of ischemic stroke in China, with the characteristics of high incidence and recurrence rates. During the endovascular treatment of ICAD, more exchange steps (if any) may lead to more complications such as vessel rupture, intracranial hemorrhage and vascular dissection. The innovative design of the Fastunnel® Delivery Balloon Dilation Catheter is closely aligned with the clinical needs, and is able to significantly simplify the operational procedures, reduce risks during the procedures, improve the safety of the procedures and reduce procedural complications of the patients.
As of this date, with regard to ICAD, Achieva’s product lines have covered a number of devices, including SacSpeed® Balloon Dilatation Catheter, Fastunnel® Delivery Balloon Dilation Catheter, Tethys® Intermediate Catheter, Presgo® Micro Guidewire and Presgo® Microcatheter. Achieva will continue to enrich the product deployment in the aspect of ischemic stroke, facilitate the construction of domestic stroke centers and popularize the interventional treatment of ischemic stroke patients.