Peijia Medical Tethys AS® Aspiration Catheter and Fastunnel® Delivery Balloon Dilation Catheter Obtained NMPA Approval

On May 20, 2022, Peijia Medical Limited (the “Company”, together with its subsidiaries, the “Group”) received the approval from the National Medical Products Administration of the PRC (the “NMPA”) for the registration application of Tethys AS ® Aspiration Catheter and Fastunnel® Delivery Balloon Dilation Catheter (formerly named as NewayTM Balloon Microcatheter), making them the Group’s twelfth and thirteenth NMPA approved neurointerventional product, respectively. 

Tethys AS® Aspiration Catheter is an acute ischemic stroke (“AIS”) revascularization product developed by Achieva Medical (“Achieva”), a wholly-owned subsidiary of the Company. The product provides an effective solution for thrombus removal, featuring a wide lumen and easy positioning. The 0.071-inch wide lumen of Tethys AS® Aspiration Catheter largely increases the aspiration force, which can significantly shorten the procedure time. It features a longer soft segment at the distal end, which conforms to the tortuous vessels and largely enhances its deliverability to the distal vessels. The optimized design of the transitional structure improves the trackability of the catheter, allowing the device to be delivered to the target vessel more easily. The entire device adopts a double-layer design with outer braids and inner coils, which allows high compressive strength and helps maintain lumen integrity. Tethys AS® aspiration catheter is available in 2 inner diameters and 4 effective lengths, with 14 different models in total. Physicians can select a proper model based on their preferences and the clinical manifestations of patients. 

According to a number of high-quality clinical studies, direct aspiration has become as a first line treatment technique for patients with AIS. As of this date, Achieva offers treatment solutions including both aspiration and stent retriever thrombectomy for AIS patients. Its product lines cover a number of devices, including Tethys AS® Aspiration Catheter, Syphonet® Stent Retriever, Tethys® Intermediate Catheter, Presgo®Micro Guidewire, Presgo® Microcatheter, and Fluxcap® Balloon Guiding Catheter (to be approved), to address the clinical needs in mechanical thrombectomy. 

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. 

In the future, 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.