Crux Biomedical, a company founded by Dr. Thomas Fogarty, the famous medical device inventor and noted winegrower, has reported highly positive results from a clinical trial of the Crux Vena Cava Filter (VCF) System in preventing recurrent pulmonary embolisms.
The new device, which is cleared for use in Europe and is under an Investigational Device Exemption (IDE) in the U.S., was designed by Fogarty and team to prevent known complications from existing devices like penetration of the caval wall, damage to nearby organs, and tilting of the filter that may allow emboli to pass.
The recently completed pivotal trial, known as the RETRIEVE Clinical Study, was a prospective, single-arm, multinational investigational study to assess the safety, performance, and efficacy of the Crux VCF System as both a retrievable and a permanent device. The trial included 125 patients at high risk for PE and was performed at 22 centers in the United States, Australia, New Zealand and Belgium.
In the study, the technical success rate of filter deployment was 98 percent; filter retrieval success was also 98 percent. The average retrieval time was 7 minutes, with the femoral approach used for retrieval in 70% of cases. By the 6-month follow up of the study, no embolizations, migrations, or fractures were observed.
Features of the Crux VCF 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
Here are videos of the deployment and retrieval of the device:
Presentation abstract from SIR 2012 Annual Scientific Meeting: The results of the Crux Vena Cava Filter RETRIEVE tria…
Product page: Crux Vena Cava Filter…