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Three Ischemic Products Approved by NMPA within Two Months
2022-06-30 18:15:20

In May and June 2022, Peijia Medical received the approval from the National Medical Products Administration of the PRC (the “NMPA”) for the registration application of Tethys AS? Aspiration Catheter, Fastunnel? Delivery Balloon Dilation Catheter and Fluxcap? Balloon Guide Catheter, successively. The approval of these three products further strengthened Peijia Medical’s ischemic product pipeline, which enabled us to provide better treatment solutions to patients suffering from intracranial atherosclerotic disease (“ICAD”) and acute ischemic stroke (“AIS”). 

Tethys AS? Aspiration Catheter is an 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. Fastunnel? Delivery Balloon Dilation Catheter is an innovative product developed by Achieva designed for treating 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 usherin 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.

 Fluxcap? Balloon Guide Catheter is developed by Achieva which is designed to address the clinical needs for balloon guide catheters (“BGCs”) and is compatible with 6F intermediate catheters or aspiration catheters. The product’s 0.087-inch large lumen shows great compatibility. The reinforced layer with transition zones leads to a balance of proximal support and distal flexibility, offering a stable passage for intracranial devices. The 0.75mm non-radiopaque segment at the tip can reduce the blind spots of the physicians and thus, improve the safety of the procedure. The compliant balloon at its tip can block proximal flow and effectively prevent the thrombus from dislodging into the distal vessels. Fluxcap? Balloon Guide Catheter is available in four effective lengths, which can satisfy various clinical needs and benefit more patients. 

In mechanical thrombectomy, the balloon guide catheter is used to arrest the antegrade flow, effectively preventing thrombus from escaping. In addition to offering a stable passage for intracranial devices, the balloon guide catheter can reduce the number of passes and therefore shorten the recanalization time. The product is also associated with higher mTICI 3 recanalization, which significantly improves the clinical outcome of patients. In recent years, the safety and efficacy of BGCs in mechanical thrombectomy have been confirmed, evidenced by the publication of a number of highquality clinical studies. The approval of Fluxcap? Balloon Guide Catheter marks that Achieva is able to provide a complete solution for AIS. The product line includes Fluxcap? Balloon Guide Catheter, Syphonet? Stent Retriever, Tethys AS? Aspiration Catheter, Tethys? Intermediate Catheter, Presgo? Micro Guidewire and Presgo? Microcatheter. 

Achieva will continue to facilitate the construction of domestic stroke centers and popularize the interventional treatment of acute ischemic stroke patients.

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