Recently, a team led by Professor Zhao Keqiang and Professor Jiang Chao from the Department of Vascular Surgery at Tsinghua University Beijing Tsinghua Changgung Hospital, under the direction of Professor Weiwei Wu, successfully performed Beijing's first case treating acute deep vein thrombosis (DVT) in the right lower limb using the WhaleFlow? Peripheral Thrombus Aspiration System. The system was independently developed by Jingtu Medical, a subsidiary of Mednovo Group.

Medical Insight: Deep Vein Thrombosis

Deep Vein Thrombosis (DVT) can lead to complications such as local venous obstruction and pulmonary embolism (PE), making it a significant cause of morbidity and mortality. Both DVT and PE fall under Venous Thromboembolism (VTE). First-line treatment for VTE typically involves systemic anticoagulation and/or systemic thrombolysis, chosen based on thrombus location and symptom severity, to prevent clot propagation or dissolve existing thrombi.

Main Treatment Options

1.Catheter-Directed Thrombolysis (CDT)

Method: A catheter is percutaneously placed within the thrombus to deliver thrombolytic agents directly, aiming to recanalize the occluded vessel with greater precision than systemic thrombolysis.

Advantages: CDT offers rapid, direct clot clearance and shorter procedure times.

Disadvantages: The overall treatment duration can extend over several days, with prolonged therapy increasing bleeding risks. It may not be suitable for patients with contraindications to anticoagulation or thrombolysis.

2.Percutaneous Mechanical Thrombectomy (PMT)

Method: This approach removes thrombi through mechanical means such as fragmentation, capture, or aspiration, rather than relying on pharmacological dissolution.

Advantages: In recent years, PMT has become a standard procedure. Compared to traditional anticoagulation therapy, PMT can promptly reduce thrombus burden, rapidly alleviate symptoms, effectively lower the risk of severe complications and long-term sequelae like Post-Thrombotic Syndrome (PTS), shorten average hospital stays, reduce thrombolytic drug usage, and minimize bleeding risks.

Case Summary

Basic Information£º

The patient is a 63-year-old female with sudden-onset swelling in the right lower limb for one week.

Past Medical History£º

oHistory of hypertension, currently managed with Losartan.

oUnderwent surgery and chemotherapy for fallopian tube tumor four months prior.

oUnderwent lithotripsy for urinary tract stones three years ago.

Specialized Examination£º

oBilateral femoral, dorsalis pedis, and posterior tibial arteries were palpable.oSevere pitting edema was observed in the right thigh and calf.oRight-sided Homans' sign (+) and Neuhof's sign (+).

Physical Findings£º

oRight leg: Circumference ~51 cm at 10 cm above the knee; ~39 cm at 10 cm below the knee.

oLeft leg: Circumference ~47 cm at 10 cm above the knee; ~35 cm at 10 cm below the knee.

Diagnosis and Treatment Strategy£º

oPreliminary Diagnosis: Lower Extremity Deep Vein Thrombosis.

oTreatment Strategy: Perform lower extremity venography + thrombus aspiration.

Procedure

Pre-procedure Angiography   

Thrombus Aspiration Procedure   

Post-aspiration Angiography   

Conclusion

Advantages of WhaleFlow? During Surgery£º

The WhaleFlow? Peripheral Thrombus Aspiration Catheter features a comprehensive range of models and accessories, enabling rapid and effective thrombus aspiration.

The use of a diverting device helps prevent larger thrombi from obstructing the aspiration catheter.

The single-use negative pressure aspiration pump is delivered as a fully sterile unit, can be placed directly on the surgical field, and allows the surgeon to directly operate and observe the thrombus aspiration, filtration process, and blood loss in real-time.

Surgeon Feedback£º

The WhaleFlow? Peripheral Thrombus Aspiration System demonstrated high overall aspiration efficiency and resulted in less blood loss compared to other products.

The ability to adjust aspiration force and blood loss by modulating the pump's rotation speed enhanced procedural safety.

The WhaleFlow? Peripheral Thrombus Aspiration System

The WhaleFlow? Peripheral Thrombus Aspiration System consists of the Single-Use Thrombus Aspiration Negative Pressure Pump (National Medical Device Registration No. 20253030722) used in conjunction with Peripheral Thrombus Aspiration Catheters (National Medical Device Registration No. 20253030243). It generates negative pressure to provide a suction source for the catheter. Once the catheter is inserted into the vessel, the negative pressure rapidly adheres to and aspirates the thrombus, restoring vascular patency.

Product Features

1. Full Range of Catheters

The thrombus aspiration catheter features a diverting/guiding device that can be advanced and retracted near the proximal edge of the primary occlusion site to help clear thrombi at the catheter tip. The device is radiopaque under X-ray fluoroscopy.

2. Fully Independent Intellectual Property Design

2.The product is equipped with an unclogging/guiding catheter to simplify intraoperative procedures. The retractable diverting device clears catheter-tip obstructions, enabling continuous aspiration. Clearly visible under DSA.

3. 3.Seven-Segment Graduated Stiffness Design:

l oSoft distal tip to prevent vessel injury.

l oPrecise torque transmission and control.

l oProvides radial support to maintain shape during negative pressure application.

l oHydrophilic coating for enhanced lubricity.

4. Comprehensive Auxiliary Accessories for Flexible and Efficient Operation

The product comes with a full suite of auxiliary accessories: core wire, shaping needle, filter mesh, torque device, introducer, introducer sheath, rotating hemostatic valve, syringes, etc.

5. Sterile Aspiration Pump Unit:

l oThe entire unit is sterile and can be placed on the surgical field, reducing infection risk.

l oFeatures one-button start and real-time suction adjustment for simple operation.

6. Simple Setup, Operation, and Disassembly

6.Portable design with a small footprint and light weight, facilitating easy movement and operation, and adaptable to various clinical environments.

7. Pulsatile Aspiration

During operation, the Single-Use Thrombus Aspiration Negative Pressure Pump generates cyclical pressure fluctuations within the tubing. This "pulsatile" pressure acts on the thrombus during aspiration, continuously adjusting the clot obstructing the catheter tip until it enters the catheter lumen.

8. Rapid Negative Pressure Response and Sustained Pressure Maintenance

Faster Response Time£º

oWhen simulating catheter tip occlusion by a thrombus, the Single-Use Thrombus Aspiration Negative Pressure Pump achieves pressure response significantly faster than traditional thrombus aspiration pumps.

Longer Pressure Maintenance£º

o After stable operation, when the device is switched off, this pump maintains pressure within the tubing for a longer duration compared to traditional thrombus aspiration pumps.