Wallaby Medical's Avenir™ Mechanical Detachable Coil Receives NMPA Approval

VCBeat (WeChat ID: vcbeat) has learned that Wallaby Medical, a medical technology company specializing in neurointervention, has received registration approval from the National Medical Products Administration (NMPA) for its independently developed Avenir™ mechanically detachable coils. This marks the first neurointerventional embolization product in China to have obtained certifications from the U.S. FDA, the EU CE, and Japan’s PMDA. The Avenir™ mechanically detachable coils are primarily used for endovascular embolization of intracranial aneurysms and other neurovascular malformations (such as arteriovenous malformations and arteriovenous fistulas), and can also be employed for arterial and venous embolization in peripheral vessels.

Source: Daily news from the National Medical Products Administration

According to data from the 2020 Health Statistics Yearbook, cerebrovascular disease ranks third in mortality rates among major diseases affecting urban residents in China, accounting for as high as 20.61% of deaths from major diseases. Cerebrovascular disease has become a significant factor impacting the life, health, and well-being of Chinese residents. As a medical technology company specializing in neurointervention, Wallaby Medical is committed to innovation and actively invests in the research, development, and production of leading products for the treatment of vascular diseases. By providing robust technical support to physicians in the field of neurology, Wallaby Medical helps advance stroke prevention and treatment capabilities in China, thereby benefiting more patients.

Wallaby Medical’s Avenir™ mechanically detachable coils offer three prominent advantages: superior basket formation, ultra-soft finishing, and immediate detachment. They provide a comprehensive and outstanding product portfolio, including excellent stable basket-forming coils, high-volume packing coils, and ultra-soft finishing coils. These devices are indicated for endovascular embolization of intracranial aneurysms and other neurovascular malformations (such as arteriovenous malformations and arteriovenous fistulas), as well as arterial and venous embolization in peripheral vessels. The Avenir™ features a reduced diameter of the primary loop to minimize coil herniation during aneurysm introduction. Its superior basket-forming capability ensures good wall apposition and optimal coil distribution, achieving dense packing. Furthermore, the Avenir™’s ultra-soft finishing coils and ultra-fine primary wire enhance softness and conformability, enabling denser packing density through exceptional spatial navigability.

An Mu, CEO of Wallaby Medical, stated, “Wallaby Medical has adopted a global perspective in its strategic layout within the neurointerventional field. By pursuing an independent R&D strategy, we have ensured internationally leading product performance, cost advantages, and sustained technological innovation capabilities. Currently, the Avenir™ mechanically detachable coil has been commercially deployed in over 20 countries and regions. We believe that obtaining registration approval from the National Medical Products Administration will further empower healthcare institutions in the neurointerventional sector, providing robust device support for physicians and patients, thereby benefiting more stroke patients in China and around the world.”

Wallaby Medical focuses on the research, development, and manufacturing of innovative products for the treatment of cerebrovascular diseases, with a vision to become the global medical technology company that saves the most lives of stroke patients. This year marks a critical milestone in the first five-year period of China’s implementation of the “Healthy China 2030” Planning Outline. Against the backdrop of the “Healthy China” initiative and independent innovation, Wallaby Medical adheres to the philosophy of independent R&D, committing to provide high-performance products for stroke patients to save more lives.

Wallaby Medical is a medical technology company specializing in neurointervention, dedicated to becoming the global leader in saving the lives of stroke patients. Wallaby Medical was founded in December 2015, and its Shanghai entity was established in July 2016. The company’s headquarters and manufacturing base are located at Shanghai Med Valley, with an R&D center in the United States. It primarily focuses on the research, development, and production of innovative products for the treatment of cerebrovascular diseases.

Wallaby Medical boasts a professional R&D team specializing in neurointervention, having developed numerous breakthrough neurointerventional products. The company is currently engaged in the research, development, and clinical trials of multiple products, and has secured dozens of patents both domestically and internationally. In 2018, Wallaby Medical became the first Chinese company to receive FDA clearance for its neurointerventional therapy products, officially entering the international market in early 2019. Its products have been exported to more than 20 countries, including the United States, Germany, the United Kingdom, and Chile.