FDA Clears TriNav Advance, Extending TriSalus PEDD Delivery to Distal Liver Vessels
核心洞察
TriSalus Life Sciences received FDA 510(k) clearance for TriNav Advance (搜索), the fourth cleared device in its Pressure-Enabled Drug Delivery portfolio.
The device adds access to small, distal vessels through a compatible microcatheter while preserving PEDD's enhanced delivery and off-target protection.
Preclinical porcine data showed PEDD increased intratumoral embolic microsphere concentration by 227% versus a traditional end-hole microcatheter.
TriSalus Life Sciences has received US Food and Drug Administration 510(k) clearance for TriNav Advance (搜索), the newest addition to its Pressure-Enabled Drug Delivery (PEDD) portfolio. The clearance, announced by the Westminster, Colorado-based oncology company, extends the platform to smaller, distal vessels and supports a broader range of embolization procedures beyond the liver.
TriNav Advance (搜索) is the fourth FDA-cleared PEDD device in the company's portfolio, joining the TriNav Infusion System (搜索) and TriNav Infusion System LV (搜索), both used for hepatic arterial infusion of liver tumors (搜索), and the Pancreatic Retrograde Venous Infusion System (搜索) for pancreatic tumors (搜索). TriSalus said it intends to initiate a limited market release of the device over the coming weeks.
Two Configurations for Vessel Anatomy
The device can be used in two configurations matched to vessel anatomy and treatment goals. In the telescoping configuration, TriNav Advance (搜索) is paired with a compatible microcatheter, with the SmartValve positioned proximal to the delivery site, enabling selective delivery to smaller, distal vessels while maintaining PEDD benefits. In the high-flow configuration, it functions like a standard TriNav device without an additional microcatheter, allowing infusion through a large lumen.
Interventional radiologists can pair TriNav Advance (搜索) with a compatible microcatheter of their choice, giving them flexibility across a broader range of procedures and anatomies. The device uses the same one-way, dynamic SmartValve mechanism found in the existing TriNav Infusion System (搜索).
The underlying PEDD mechanism relies on a one-way dynamic microvalve that modulates blood flow and pressure once placed within the vasculature. Forward blood flow is retained after device placement, allowing therapeutics to migrate downstream into the target vascular network. During infusion, pressure can be generated locally within the arterial network without risk of reflux into non-target tissue. This hemodynamic modulation is designed to enhance penetration of embolic agents and other therapeutics into solid tumors (搜索) while limiting exposure to surrounding healthy tissue.
Preclinical Evidence
Preclinical data support the PEDD approach. In a porcine liver tumor model published in the Journal of Vascular and Interventional Radiology, PEDD delivered via a TriNav device increased the concentration of fluorescently labeled embolic microspheres within tumor tissue by 227% (P = .029) compared with a traditional end-hole microcatheter, and improved the tumor-to-normal tissue ratio from 2.7 to 4.2.
A separate porcine model study using glass microspheres, which received two Journal of Vascular and Interventional Radiology Top Paper Awards in 2025, found that PEDD increased tumor penetration by 117% (P = .004) in lobar infusions and by 39% (P = .032) in selective infusions compared with a traditional microcatheter.
TriNav Advance (搜索) was cleared through the FDA's 510(k) pathway based on substantial equivalence to predicate PEDD devices. It shares the same core SmartValve mechanism evaluated in these studies, though it has not itself been the subject of a dedicated published investigation.
Investigator-Led Trial in Liver Tumors
The PREDICTT trial (NCT07444645) is an investigator-led, single-arm, prospective, interventional study at the University of Texas MD Anderson Cancer Center evaluating PEDD delivery via the TriNav Infusion System (搜索) in approximately 20 adults with unresectable primary or metastatic liver tumors (搜索) undergoing yttrium-90 (Y90) radioembolization.
Led by principal investigator Peiman Habibollahi, MD, associate professor of interventional radiology at MD Anderson, the trial's primary endpoint is to evaluate changes in CT-based tumor-to-normal liver enhancement ratios using TriNav. Secondary endpoints include the correlation between these imaging measures and tumor dose, nontumoral liver dose, and microsphere distribution following Y90 treatment, as well as safety of the catheter.
Company Commentary
"TriNav Advance (搜索) enhances our Pressure-Enabled Drug Delivery portfolio in support of the full range of liver embolization procedures," said Mary Szela, president and chief executive officer of TriSalus. "We are proud of the range of tools we offer to physicians and believe TriNav Advance will catalyze further adoption across these procedures. We're excited to broaden our portfolio in a way that can meaningfully benefit both physicians and patients."
"The TriNav Advance (搜索) 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, 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 clinically meaningful. This is a natural extension of the technology into cases we haven't been able to fully address before."
Immunotherapy Pipeline
Beyond its device portfolio, TriSalus is developing nelitolimod, a class C Toll-like receptor 9 agonist, as an investigational immunotherapeutic. The candidate is designed to treat the immunosuppressive environment created by many tumors, which can make current immunotherapies ineffective in the liver and pancreas. Its target, TLR9 (搜索), is expressed across cancer types, and the mechanical barriers addressed by PEDD are commonly present as well.
Patient data generated during the company's Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials support the hypothesis that nelitolimod delivered via PEDD technology may have favorable immune effects within the liver and systemically. TriSalus said it has completed three Phase 1 clinical trials of nelitolimod and will begin exploring partnership opportunities for development.