Pulse Medical's Leftear Left Atrial Appendage Occluder System Receives NMPA Approval, Advancing Domestic Substitution in High-End Cardiovascular Devices

Sep 30, 2022 17:31 CST Updated 17:31

Pulse Medical

Cardiovascular Medical Device R&D, Production, and Sales Company

VCBeat learned that,Guangdong Pulse Medical Technology Co., Ltd. (referred to as "Pulse Medical")"）independently developed by"Leftear Left Atrial Appendage Occluder System", which received registration approval from the National Medical Products Administration (NMPA) on September 29, 2022, obtainingClass III"Medical Device Registration Certificate", Registration No."Guo Xie Zhu Zhun 20223131295"。

Pulse Medical's Leftear Left Atrial Appendage Occluder is suitable forThrombosis Treatment and Control in Patients with Non-Valvular Atrial Fibrillation, which is a method to replace the traditional use of anticoagulant drugs for treating thrombosis in patients with atrial fibrillation. Since the research project was initiated in January 2015, Pulse Medical has continuously explored clinical pain points, overcome difficulties, and strived for perfection. After countless iterations and refinements, it has finally received registration approval.

Leftear Left Atrial Appendage Occluder has made significant innovations based on the structural designs of existing similar products globally, and innovatively developed the current...The world's only "Double-Body Inner-Plug Type"Structure. The Leftear Left Atrial Appendage Occluder System mainly includesLeft Atrial Appendage OccluderAndDelivery SystemTwo major components, where the left atrial appendage occluder includes main structures such as the fixation disc and occlusion disc, and the delivery system includes components such as the delivery sheath, dilator, delivery cable, and loader.

Compared with similar products abroad, the Leftear Left Atrial Appendage OccluderThe unique trapezoidal structure of the occluder design allows the occluder to have stronger adaptability within the left atrial appendage, achieving a more ideal occlusion effect.Outstanding performance,More Suitable for Cardiovascular Structural Characteristics of Asians. This product is easier to operate,PatientSmaller trauma.Due to the unique structural design, the physician can repeatedly retract and deploy the left atrial appendage occluder during the operation, ensuring the safety of the surgery.

Pulse Medical's Leftear Left Atrial Appendage Occluder System was recommended as one of the "Six Outstanding Chinese Original Research" cardiovascular medical devices at the 2020 China Interventional Cardiology Conference (CIT-2020) to participate in the 2020 European Association of Percutaneous Cardiovascular Interventions (EuroPCR-2020). The research team presented clinical trial data demonstrating the safety and efficacy of the Leftear Left Atrial Appendage Occluder at a special session of EuroPCR-2020, receiving high praise from experts around the world.

The market demand for left atrial appendage closure devices is enormous. Taking the left atrial appendage closure device product from Boston Scientific Corporation as an example, this product obtained registration approval from the U.S. Food and Drug Administration (FDA) in the first half of 2015. In recent years, despite the impact of the global COVID-19 pandemic, the product achieved sales revenue of approximately US$830 million, equivalent to about RMB 5.5 billion, in the fiscal year 2021. China's population base is about four times that of the total U.S. population, so the left atrial appendage closure device product will have even greater market growth potential in China.