The FDA has granted 510(k) clearance for TriNav Advance, a catheter-based device that extends TriSalus Life Sciences’ Pressure-Enabled Drug Delivery (PEDD) technology to smaller, distal hepatic vessels, according to a news release from the company.1 TriNav Advance uses the same one-way, dynamic SmartValve mechanism found in the company’s existing TriNav Infusion System, which has been evaluated in peer-reviewed preclinical studies for its ability to improve intratumoral drug and microsphere penetration during liver embolization procedures.
How does TriNav Advance’s SmartValve technology work?
TriNav Advance can be used in 2 configurations depending on vessel anatomy and treatment goals. In a telescoping configuration, the device is paired with a compatible microcatheter, with the SmartValve positioned proximal to the delivery site to enable selective delivery to smaller, distal vessels while preserving the benefits of PEDD. In a high-flow configuration, the device functions like a standard TriNav device without an additional microcatheter, allowing infusion through a large lumen.
The underlying PEDD mechanism relies on a 1-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.2 This hemodynamic modulation is designed to enhance the penetration of embolic agents and other therapeutics into solid tumors while limiting exposure to surrounding healthy tissue.
“TriNav® Advance enhances our Pressure-Enabled Drug Delivery™ portfolio in support of the full range of liver embolization procedures,” stated Mary Szela, president and chief executive officer of TriSalus, in the press release.1 “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.”
What preclinical data support the PEDD approach behind TriNav Advance?
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 4.2.3 A separate porcine model study using glass microspheres, which received 2 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.4
TriNav Advance 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.
What ongoing clinical research is evaluating PEDD technology 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 the impact of PEDD delivery via the TriNav Infusion System in approximately 20 adults with unresectable primary or metastatic liver tumors undergoing yttrium-90 (Y90) radioembolization.5
Led by principal investigator Peiman Habibollahi, MD, associate professor of interventional radiology at MD Anderson, the trial’s primary end point is to evaluate changes in CT-based tumor-to-normal liver enhancement ratios using TriNav. Secondary end points 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.
What is TriSalus’s broader PEDD portfolio?
TriNav Advance is the fourth FDA-cleared PEDD device in TriSalus’s portfolio, joining the TriNav Infusion System and TriNav Infusion System LV, both used for hepatic arterial infusion of liver tumors, and the Pancreatic Retrograde Venous Infusion System, used for pancreatic tumors.
“The TriNav® Advance clearance marks a seminal moment for TriSalus Life Sciences, enabling us to expand our impact, particularly in cases involving tortuous anatomies,” added Richard Marshall, MD, chief medical officer of TriSalus.1 “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.”
References
- TriSalus Life Sciences receives FDA clearance for TriNav Advance, strengthening comprehensive Pressure-Enabled Drug Delivery portfolio for liver embolization. News release. TriSalus Life Sciences, Inc. September 22, 2026. Accessed September 24, 2026. https://tinyurl.com/muf27wpy
- Cournoyer L, Liu Y, Jaroch DB, et al. Pressure enabled drug delivery (PEDD) of nelitolimod increased therapeutic delivery, reduced immunosuppression, and improved efficacy in porcine and murine liver tumor models. Front Oncol. 2025;15:1655794. doi:10.3389/fonc.2025.1655794
- Jaroch DB, Liu Y, Kim AY, et al. Pressure-enabled drug delivery significantly increases intra-arterial delivery of embolic microspheres to liver tumors in a porcine model. J Vasc Interv Radiol. 2025;36(3):499-504.e1. doi:10.1016/j.jvir.2024.11.014
- Jaroch DB, Liu Y, Kim AY, et al. Intra-arterial pressure-enabled drug delivery significantly increases penetration of glass microspheres in a porcine liver tumor model. J Vasc Interv Radiol. 2024;35(10):1525-1533.e4.
- Prospective evaluation of pressure-enabled delivery and alterations in CT-based tumor-to-normal liver ratio and tumor dose using the TriNav infusion system (PREDICTT). ClinicalTrials.gov. Updated September 1, 2026. Accessed September 23, 2026. https://tinyurl.com/5e9dh24b
