IR Update: FDA Clears New Device for Liver Embolization Procedures

The Food and Drug Administration (FDA) has issued 510(k) clearance for the TriNav Advance device, which may offer enhanced small distal vessel access for interventional radiologists performing liver embolization procedures.

TriSalus Life Sciences, the manufacturer of the TriNav Advance device, said it offers two configurations to help address variations with vessel anatomy and treatment goals.

Along with a compatible microcatheter, one may employ the telescoping configuration of the TriNav Advance with proximal positioning of the device’s SmartValve to ensure targeted delivery to smaller distal vessels, according to TriSalus Life Sciences.

For procedures requiring infusion through a large lumen, the company said the high-flow configuration of the TriNav Advance device can be utilized in a similar manner to standard TriNav devices without the need for an additional microcatheter.

“The TriNav^® Advance clearance marks a seminal moment for TriSalus Life Sciences, enabling us to expand our impact, particularly in cases involving tortuous anatomies,” said Richard Marshall, MD, the chief medical officer of TriSalus. “We believe that physicians can now optimize therapeutic delivery in difficult cases while limiting exposure to unaffected anatomical structures, which has been central to what makes PEDD (pressure-enabled drug delivery) clinically meaningful. This is a natural extension of the technology into cases we haven’t been able to fully address before.”