Fishhawk® Disposable Thrombectomy Device Cleared for Deep Vein Thrombosis Is Approved by NMPA

On April 30, the Fishhawk® Disposable Thrombectomy Device of MicroPort Endovascular was approved by NMPA for commercialisation in China. Previously granted entry into the NMPA’s Green Channel for Innovative Medical Devices in 2022, this product is indicated for the percutaneous endovascular removal of acute iliac and deep femoral vein thrombosis. Utilizing an innovative clot-clearing mechanism and partition technology, the device effectively minimizes postoperative complications and catheter clogging, offering a pioneering therapeutic option for deep vein thrombosis clearance.

Product Composition and Scope of Application

The system consists of a Disposable Thrombectomy Catheter and a Control Handle (with an integrated battery), which are used in tandem with standard introducer sheaths and guidewires. Engineered for the percutaneous removal of acute iliac and deep femoral vein thrombi, the device features a streamlined, integrated design utilizing coaxial dual-channel technology to mechanically aspirate and fragment blood clots.

The primary target patient population includes individuals suffering from acute-stage iliac and deep femoral vein thrombosis, particularly cases involving high clot burdens. Percutaneous Mechanical Thrombectomy (PMT) has emerged as the preferred clinical pathway for treating acute high-burden DVT, celebrated for its ability to swiftly clear clots with minimal trauma and fewer procedural complications.

Key Technical Innovations

The Fishhawk® system introduces a completely reimagined mechanism of action, distinguished by the following clinical advantages:

• Internal Fragmentation and Instant Evacuation: Clots are fragmented within the catheter and instantly evacuated. This satisfies the intense clinical demand for high-burden venous clot clearance while significantly mitigating the risks of procedural complications such as hematuria and acute renal failure.
• Proprietary Anti-Winding Partition Technology: A unique internal barrier isolates the captured thrombus from the device’s driving components, preventing mechanical entanglements and catheter clogging.
• Steerable Deflection with Radiopaque Guidance: The catheter features a steerable, adjustable tip outfitted with highly visible radiopaque markers, allowing clinicians to achieve high-precision aspiration directly at the site of the clot.
• Integrated Portable Configuration: The battery-operated handle completely integrates both the mechanical drivetrain and the negative-pressure aspiration system. By eliminating the need for external power cords or consoles, the entire unit remains lightweight and portable.