TriSalus Expands PEDD Portfolio

Company introduces TriNav LV Infusion System and TriGuide Guiding Catheters to its lineup.

By: Michael Barbella

Managing Editor

TriNav LV. Photo: TriSalus Life Sciences Inc.

TriSalus Life Sciences Inc. has officially launched the TriNav LV Infusion System and TriGuide Guiding Catheter, devices designed to optimize therapeutic delivery, enhance treatment options, and potentially improve patient outcomes.

The launch expands TriSalus’ proprietary pressure-enabled drug delivery (PEDD) product offerings, which now cover vessel sizes from 1.5 mm to 5.0 mm. The augmented vessel sizes provide interventional radiologists with a broader range of treatment options and increase the devices’ total addressable market.

The TriNav LV Infusion System is tailored for larger vessels (3.5 mm-5 mm), thereby increasing the number of suitable patients for TriSalus’ PEDD technology. The larger patient population does not affect the product’s reimbursement eligibility: Providers use the same HCPCS codes—C9797 for procedures and C1982 for devices—as the existing TriNav products, supporting seamless integration into current billing structures.

In a limited market release, physicians reported a 97% satisfaction rate with the TriNav LV Infusion System, underscoring its clinical effectiveness and ease of use.

“We are thrilled to introduce TriNav LV, an infusion system developed in direct response to customer feedback for a larger-diameter PEDD device suited for lobar therapeutic delivery in patients with larger vessels,” TriSalus President/CEO Mary Szela said. “This launch is a testament to our commitment to meeting clinician needs and marks the first of several products we plan to introduce over the next 12 to 18 months. Our focus remains on advancing our pipeline to make a significant difference in patient outcomes and to drive progress in cancer treatment.”

The new TriGuide Guiding Catheters, uniquely equipped with a larger inner diameter, lubricious inner lining, and reverse curve design, are the first of their kind to support femoral access for the TriNav LV Infusion System, enhancing procedural efficiency.

TriSalus Life Sciences is an oncology-focused medical technology business providing drug delivery technology to help improve therapeutics delivery to liver and pancreatic tumors. The company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. Its two U.S. Food and Drug Administration-cleared devices use a PEDD approach to deliver a range of therapeutics: the TriNav Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors.

PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes.

In partnership with U.S. cancer centers and by leveraging deep immuno-oncology expertise and inventive technology development, TriSalus strives to advance innovation that improves patient outcomes.

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