StrenSoft™ Steerable Pulmonary Artery Thrombectomy Stent System Approved by NMPA

Developed by Shanghai Shineyo Medical, the StrenSoft™ Steerable Pulmonary Artery Thrombectomy Stent System is a Class III innovative medical device approved via China’s NMPA innovation green channel in June 2026. It stands as the first domestic full-set mechanical thrombectomy system equipped with intraoperative bidirectional steering functionality, offering a purely micro-invasive, percutaneous peripheral vascular approach to clearing pulmonary artery thrombi without the need for open-heart surgery.

Technical Mechanisms & Specs

• System Configuration: Available in Steerable and Hydrophilic-Coated kit configurations. The full sterile, single-use kit includes a nitinol thrombectomy stent catheter, a dedicated aspiration catheter, and operational accessories.
• Action Mechanism: Utilizes a synergistic mechanical capture + negative-pressure aspiration mechanism. The nitinol self-expanding mesh capture stent traps the clot and retracts into the aspiration catheter, while concurrent negative pressure extracts the thrombus cleanly to prevent fragmentation and secondary distal embolization.
• Bidirectional Steering: The delivery handle enables real-time, intraoperative bidirectional tip deflection. This eliminates the need for pre-surgical ex-vivo shaping, allowing clinicians to navigate highly tortuous and angled pulmonary artery branch anatomies with ease.

Core Clinical Indications

The system is indicated for transcatheter mechanical thrombus removal in patients with acute high-risk pulmonary embolism (PE) or progressive/worsening intermediate-risk PE, specifically targeting:

1. Patients with massive thrombi in the main pulmonary artery or major branches who present with systemic thrombolysis contraindications or high bleeding risks (e.g., advanced age, post-operative status, history of cerebral hemorrhage).
2. Patients whose hemodynamics continue to deteriorate and whose thrombi remain unresolved after conservative medical therapies (e.g., anticoagulation or thrombolysis).

Key Differentiating Advantages

• First-in-Class Steering: Unlike traditional fixed, straight-tip catheters that struggle in complex anatomies, StrenSoft™’s real-time steering significantly improves target vessel access rates and slashes emergency procedural times.
• Elimination of Severe Bleeding Risks: By replacing high-dose systemic thrombolytic drugs with mechanical extraction, it drops the risk of fatal intracranial or gastrointestinal hemorrhages, maintaining an overall procedural complication rate below 5%.
• Superior Thrombus Clearance: The combined capture-and-aspirate method completely removes large clots, instantly restoring right ventricular blood flow, reversing shock/hypoxia, and reducing the long-term incidence of Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
• Simplified, Low-Barrier Operation: The removal of the ex-vivo shaping step lowers the technical barrier for clinicians, shortens radiation exposure times, and facilitates rapid deployment in emergency rooms and lower-tier intervention centers.