FengKaili Medical Receives Class II Medical Device Registration Certificate for Its Innovative Guiding Sheath Set

Nov 27, 2023 17:36 CST Updated 17:36

ForQaly

Minimally Invasive Heart Ventricular Assist Device Developer

Click on the blue above"Medicine Valley"Follow Us

Recently, ForQaly Medical (Shanghai) Co., Ltd. (hereinafter referred to as "ForQaly") announced that its self-developed "Catheter Sheath Set" obtained the Class II Medical Device Registration Certificate of China (Shanghai Medical Device Approval No. 20232030316). This is reported to be the first medical device registration certificate approved in the field of percutaneous ventricular assist interventional access products in China.

Image Source: ForQaly Official WeChat Account

According to the introduction, the "Catheter Sheath Set" is designed to establish a minimally invasive percutaneous interventional surgical pathway for patients. It consists of a splittable catheter sheath, dilator, 0.035" contrast guidewire, and 0.018" stiff guidewire, and is compatible with products that have long-term interventional needs, such as the SynFlow®3.0 Percutaneous Transvalvular Ventricular Assist System developed by ForQaly. As the first product in China to be used in conjunction with a percutaneous ventricular assist device (pVAD), the "Catheter Sheath Set":

① The tearable catheter sheath is compatible with devices up to 14Fr. The hemostatic valve adopts a double-layer sealing design, combined with a unique cutting process, ensuring excellent puncture stability, device delivery performance, hemostatic performance, and support performance while also guaranteeing superior tearability, thereby reducing the occurrence of distal ischemia during long-term device management and minimizing surgical complications.

② Equipped with 10F/12F/14F dilators featuring a lubricious coating, allowing for smoother progressive vascular dilation, reducing access-related vascular injury, and lowering the risk of vascular complications.

③The 14F dilator is available in two lengths, allowing for flexible selection based on the tortuosity of the blood vessels during intervention.

④Two guidewires are provided for safe and effective access to the left ventricle, facilitating subsequent device introduction. The 0.018" extra-stiff guidewire, with its robust design, offers excellent support, while the soft tip coil design reduces the risk of vascular complications and ventricular injury.

Data shows that ForQaly was established in September 2015 and is now located in the Shanghai International Medical Park in Zhangjiang Science City. The company specializes in the development of minimally invasive circulatory assist devices. It has built a workplace of over 4,000 square meters integrating production, R&D, and office functions and obtained ISO 13485 international quality system certification. To date, ForQaly has raised 455 million yuan in financing from well-known funds in the biopharmaceutical field, including Lilly Asia Ventures, Zhangjiang Sci-Tech Investment, Legend Capital, and CD Capital.

Text | MedValley