Vena Cava Filter


Product NameVena Cava Filter
ClassificationClass III
Review DivisionCenter for Medical Device Evaluation of NMPA
Applicant NameKossel Medtech (Suzhou) Co., Ltd.
Registration PathwayDomestic Device
Innovation Pathway
Product DescriptionThe Vena Cava Filter is composed of a filter and a conveying system. The filter is an umbrella structure that includes a balance arm and a support rod and is cut and expanded by a nickel-titanium alloy pipe. The conveying system consists of a sheath (including asheath-core), an introducer, and a pushrod. The filter is pre-installed in the introducer. The product has been sterilized by EO and is disposable with a 3-year shelf -life.
Indications for UseThe product was implanted percutaneously through the femoral vein or jugular vein to prevent pulmonary embolism (PE) caused by thrombus falling off of the inferior vena cava system, including:  

1. Patients with PE or thrombosis of inferior vena cava and iliac, femoral, and popliteal veins have one of the following conditions:

(1) Contraindications to anticoagulant therapy;
(2) Bleeding and other complications occurred during anticoagulant therapy;
(3) PE still recurred after adequate anticoagulant treatment and could not achieve adequate anticoagulation for various reasons.  

2. PE, with lower extremity deep venous thrombosis.

3. There are free-floating thrombus or a large number of thrombus in the iliac vein, femoral vein, or inferior vena cava.

4. Those diagnosed with thrombophilia and recurrent PE.

5. Patients with acute lower extremity deep venous thrombosis who want to undergo transcatheter thrombolysis and thrombus clearance
Summary of Non-Clinical TestingThe applicant submitted the following non-clinical research materials:
· Product performance research
· Biocompatibility
· Sterilization
· Product shelf-life and packaging
· Animal study  

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Summary of Clinical Evaluation · Clinical pathway: clinical trial
· Clinical design: multicenter, randomized, positive parallel control, and non-inferior effect
· Site number:  10 sites
· Sample size: 188 subjects.Primary evaluation index: clinical success, including the clinical success of filter placement and filter removal.
· Secondary evaluation index:
(1) The success rate of conveying sheathsystem;
(2) Incidence of pulmonary embolism (6 months);
(3) The incidence of filter fracture, migration (> 20mm) and inclination (15 °) during insertion/removal;
(4) Inferior vena cava blood flow (within 6 months).  

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Product Risk/Benefit AnalysisThe main benefits are  preventing or reducing pulmonary embolism caused by thrombus falling off of deep vein thrombosis of the inferior vena cava system.  

The main risks include:
· The filter is tilted and difficult to take out;
· Filter shift;
· Filter broken;
· Perforation of inferior vena cava;
· Intimal injury of inferior vena cava;
· Inferior vena cava obstruction;
· Recurrence of pulmonary embolism caused by the dislodged  embolus of deep vein thrombosis in the inferior vena cava system;
· Other rare complications  

However, in order to ensure the safety of the use of machinery, based on the avoidance of the main residual risks, it is necessary to include the following information in the IFU:
· Warnings and precautions
· Contraindications
· Product indication for use
· Others

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