On June 8, 2022, Peijia Medical received the approval from the National Medical Products Administration of the PRC (the “NMPA”) for the registration application of Fluxcap® Balloon Guide Catheter, making it the Company’s fourteenth NMPA approved neurointerventional product.
Fluxcap® Balloon Guide Catheter is developed by Achieva Medical, a wholly-owned subsidiary of the Company. It 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, thus improving 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 mTICI3 recanalization, which significantly improves the clinical outcome of patients. In recent years, the safety and efficacy of BGCs in mechanical thrombectomy has been confirmed, evidenced by the publication of a number of high-quality clinical studies.
The approval of Fluxcap® Balloon Guide Catheter marks that Achieva is able to provide a complete solution for acute ischemic stroke. Its 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.
