Skynor Medical's SkyFlow® Thrombectomy Device Receives NMPA Approval for Treatment of Acute Ischemic Stroke

On May 17, the "thrombectomy device (trade name: SkyFlow®)", independently developed by Skynor Medical (Shanghai) Co., Ltd. (hereinafter referred to as "Skynor Medical") located in the Shanghai International Medical Zone within Zhangjiang Science City, officially passed the registration review by the National Medical Products Administration (NMPA) and is indicated for the recanalization of intracranial occluded vessels in patients with acute ischemic stroke.

The SkyFlow® Thrombectomy Device is the core product of Skynor Medical, with its development initiated in 2016. Structurally, the device features a dual-helix closed-loop design that provides high flexibility and ensures optimal engagement with thrombi. Its radiopaque configuration incorporates multi-segment markers, enabling physicians to accurately assess the deployed configuration, thrombus engagement status, and thrombus length, thereby improving both thrombectomy success rates and procedural efficiency. Owing to its superior performance, the SkyFlow® Thrombectomy Device demonstrated outstanding efficacy in a randomized controlled clinical trial, achieving an intracranial vessel recanalization rate of nearly 90%.

To date, Skynor Medical has filed 28 patent applications and initially established a relatively comprehensive portfolio of neurointerventional product solutions. For ischemic stroke, its representative products include the approved SkyFlow® thrombectomy device and intracranial balloon dilation catheter. The access product line comprises distal access catheters, microcatheters, and balloon guide catheters, among others. Meanwhile, products for hemorrhagic stroke, such as intracranial flow diverter stents and intracranial aneurysm stents, are also advancing rapidly.

Furthermore, among peripheral interventional products, the next-generation peripheral vascular stent independently developed by Skynor Medical is currently undergoing a multi-center controlled clinical trial, demonstrating excellent preliminary clinical efficacy. Additionally, several other interventional products, including peripheral balloon dilatation catheters and PTA balloon dilatation catheters, have received NMPA approval for market launch.

Previously, in January 2021, Skynor Medical closed a Series B funding round of nearly RMB 100 million, led by Zeyue Capital.