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Initial experience in humans with a new retrievable inferior vena cava filter
1Department of Medical Imaging, Mount Sinai Hospital/University Health Network, 600 University Ave, Suite 564, Toronto, Ontario, Canada M5G 1X5. masch@mtsinai.on.ca
Radiology
|December 4, 2002
Summary
The Recovery nitinol filter (RNF) effectively prevents pulmonary embolism and deep vein thrombosis. Retrieval of the RNF is safe and feasible in humans, even after extended implantation periods.
Area of Science:
- Vascular Surgery
- Interventional Radiology
- Medical Device Technology
Background:
- Inferior vena cava filters (IVCFs) are crucial for preventing pulmonary embolism.
- Nitinol-based filters offer potential advantages in retrieval and biocompatibility.
- The Recovery nitinol filter (RNF) is a newer device requiring clinical evaluation.
Purpose of the Study:
- To assess the preliminary clinical efficacy of the Recovery nitinol filter (RNF) in humans.
- To evaluate the safety and feasibility of RNF retrieval.
- To determine the optimal implantation duration for RNF.
Main Methods:
- A prospective study involving 32 patients treated with the RNF.
- Evaluation of filter placement success and retrieval rates.
- Monitoring for complications such as pulmonary embolism and thrombosis.
Main Results:
- The RNF was successfully placed in all 32 patients.
- Filter retrieval was successful in 100% of 24 patients via a jugular approach.
- Mean implantation duration was 53 days (range 5-134 days), with no reported pulmonary embolism or insertion-site thrombosis.
Conclusions:
- The Recovery nitinol filter (RNF) demonstrates high efficacy in preventing thromboembolic events.
- RNF retrieval is a safe and feasible procedure in humans.
- The device can be safely retrieved up to 134 days post-implantation.