Crux Biomedical has received CE mark approval for its inferior vena cava filter (IVCF) with bi-directional retrieval. Inferior vena cava filters are implanted to trap blood clots that may cause pulmonary embolism in patients who are at high risk but have contraindications to anticoagulation.
The Crux Biomedical IVCF was designed to overcome several limitations of currently available vena cava filters including perforation, migration and inability to retrieve. Features, from the product page:
- Self-centering – no-tilt symmetrical spiral design centers filter automatically in vessel lumen
- Bi-directional deployment and retrieval. Twice the retrieval options of other filters. Designed for either jugular or femoral deployment, and retrieval
- Atraumatic design goal – Tissue anchor lengths optimized for efficient vessel fixation while limiting perforation
- Total trans-luminal filtration design provides filtration across the entire lumen of the vessel
- Controlled filter placement via preloaded, low profile, over-the-wire delivery system
A pivotal trial showed that the filter could be retrieved with a 98% success rate. In addition to European approval, the company anticipates submission to the FDA in January and U.S. approval in 2012.
Press release: Crux Biomedical’s IVC Filter Receives CE Mark Approval…
Product page: Crux IVC Filter…