{"id":19616,"date":"2026-09-28T05:15:21","date_gmt":"2026-09-28T08:15:21","guid":{"rendered":"https:\/\/rtmedical.com.br\/tmp-en-1790583321326\/"},"modified":"2026-09-28T05:15:27","modified_gmt":"2026-09-28T08:15:27","slug":"trinav-advance-fda-liver-embolization","status":"publish","type":"post","link":"https:\/\/rtmedical.com.br\/en\/trinav-advance-fda-liver-embolization\/","title":{"rendered":"FDA Clears TriNav Advance for Liver Embolization"},"content":{"rendered":"

The FDA has granted 510(k) clearance to TriNav Advance<\/strong>, a new infusion catheter from TriSalus Life Sciences for liver embolization<\/strong> that extends pressure-enabled drug delivery (PEDD) to small, distal vessels. Announced on September 22 by the Westminster, Colorado company (Nasdaq: TLSI) and reported by Diagnostic Imaging<\/em>, it is the first TriNav model that can be paired with a conventional microcatheter while keeping the SmartValve in a proximal position to block reflux in tortuous anatomy.<\/p>\n

\"Angiography
Angiography suite: procedures such as TACE and Y-90 radioembolization depend on selective infusion catheters. Photo: Pexels.<\/figcaption><\/figure>\n

What the FDA cleared and how the device works<\/h2>\n

According to TriSalus, TriNav Advance can be used in two configurations chosen to match vessel anatomy and treatment goals. In the telescoping<\/strong> configuration, the device is paired with a compatible microcatheter of the interventional radiologist’s choice; the SmartValve sits proximal to the infusion site while the microcatheter advances into smaller, more distal branches, preserving the PEDD effect. In the high-flow<\/strong> configuration, the catheter is used like a standard TriNav, with no additional microcatheter, for infusions that call for a large lumen.<\/p>\n

The company says the cleared indication supports embolization procedures beyond the liver and that a limited market release will begin over the coming weeks. Richard Marshall, MD, TriSalus’s chief medical officer, called the clearance a “seminal moment” for the company, with the biggest impact expected in cases involving tortuous anatomy: in his view, physicians can now optimize therapeutic delivery in difficult cases while limiting exposure of unaffected structures. Mary Szela, president and CEO, said the product rounds out the portfolio for the full range of liver embolization procedures and should drive further adoption.<\/p>\n

With the new catheter, TriSalus’s PEDD line comprises the TriNav Infusion System and its LV version for hepatic arterial infusion, plus the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The company is also developing nelitolimod, an investigational class C TLR9 agonist evaluated in the PERIO (Pressure-Enabled Regional Immuno-Oncology) trials; three Phase 1 studies are complete and the company says it will seek partners for further development.<\/p>\n

PEDD and SmartValve: the physics behind the catheter<\/h2>\n

The SmartValve is a self-expanding, non-occlusive, one-way microvalve at the catheter tip. It opens and closes in step with the cardiac cycle: during systole, antegrade flow partially collapses the valve and lets particles through; during diastole, it expands against the vessel wall and prevents reflux. The result is a partially isolated vascular compartment in which infusion pressure and progressive distal embolization raise local pressure, helping overcome the high interstitial pressure typical of solid tumors. A review published in July 2026 in Cancers<\/em> by Eggleston, Makary and colleagues cites a mean 22 mmHg drop in downstream arterial pressure once the valve deploys, which characterizes this partitioning effect.<\/p>\n

The most frequently cited clinical evidence is a retrospective analysis published in 2019 in CardioVascular and Interventional Radiology<\/em> by Titano and colleagues at Mount Sinai, covering 88 patients who underwent drug-eluting microsphere TACE for solitary hepatocellular carcinoma. In the 18 cases treated with a microvalve catheter, the authors found better tumor response, more microsphere deposition inside the tumor and a higher percentage of necrosis at explant compared with the 70 cases treated with an end-hole catheter. It is a small, non-randomized series, and the 2026 review itself stresses that larger prospective trials are still lacking.<\/p>\n

On the real-world side, Gupta and colleagues analyzed in Current Medical Research and Opinion<\/em> (2024) records of 603 PEDD patients and 16,210 controls who underwent TACE or TARE between January 2020 and March 2024. After matching, the PEDD group reported less fatigue (20.9% versus 26.4%) and had fewer inpatient visits in the 30 days after TACE. The study is observational and manufacturer-funded, which calls for cautious reading.<\/p>\n

Why this matters for Y-90 dosimetry<\/h2>\n

For medical physics readers, the most interesting angle is yttrium-90 radioembolization, or TARE. Treatment planning relies on a mapping procedure with Tc-99m macroaggregated albumin (MAA), from which the lung shunt fraction and the tumor-to-normal liver ratio (T\/N) are derived to feed the partition model or voxel-based dosimetry. Any difference in catheter position or hemodynamics between mapping and treatment translates into absorbed-dose error in both tumor and parenchyma.<\/p>\n

This is where PEDD comes in: by suppressing reflux and reshaping flow distribution, it may change T\/N and microsphere penetration. A preclinical porcine study published in the Journal of Vascular and Interventional Radiology<\/em> in 2024 reported increased intratumoral penetration of both glass and embolic microspheres with the technique. Ongoing trials registered on ClinicalTrials.gov are testing exactly these hypotheses in humans: one compares Y-90 infusion with TriNav and with an end-hole microcatheter within the same patient; another assesses whether MAA mapping through TriNav better predicts the final microsphere distribution; and the PREDICTT study measures CT-based T\/N and the resulting tumor dose. Until those results are published, the dosimetric advantage of PEDD in TARE should be treated as plausible rather than proven.<\/p>\n

There is also a practical point: with the telescoping configuration, the physicist needs to know that the valve sits proximal to the microcatheter that actually releases the microspheres. That affects activity calculation when the target is a small segment, and it reinforces the importance of documenting the position of both devices in the procedure record. For target definition in HCC, the same principles apply as in our guide on hepatocellular carcinoma target delineation in radiotherapy<\/a>.<\/p>\n

Regulatory landscape, reimbursement and the Latin American reality<\/h2>\n

In the United States, CMS created HCPCS code C9797 in 2024 for TriNav procedures in the hospital outpatient setting, assigned to APC 5194 (Level 4 endovascular procedures) with a national base payment of $16,724.70 that year; device code C1982 remains in force to identify the catheter on claims. That dedicated reimbursement is one reason the technology has gained traction in the US market.<\/p>\n

In Brazil, hepatic radioembolization has been available in private and university centers since 2014 with SIR-Spheres resin microspheres, and since 2019 with TheraSphere glass microspheres, both registered with ANVISA. Coverage by private health plans became mandatory under ANS Normative Resolution 542\/2022 for intermediate or advanced, unresectable hepatocellular carcinoma without extrahepatic disease when chemoembolization is inadequate; the public SUS system has not incorporated the procedure. There is no public record of TriNav Advance registration with ANVISA, and TriSalus did not mention international expansion plans in its announcement. On the metrology side, researchers at Brazil’s IRD\/LNMRI published in the Brazilian Journal of Radiation Sciences<\/em> an overview noting that activity standardization for Y-90 microspheres in the country is not yet consolidated, a reminder that traceability comes before any fine-grained discussion of catheter-driven dosimetry gains.<\/p>\n

How the new catheter fits the interventional imaging ecosystem<\/h2>\n

TriNav Advance arrives as angiography vendors invest in navigation tools for embolization, such as Siemens’s AI angiography for embolization<\/a> and GE’s upgrades for interventional systems<\/a>. Pressure-controlled catheters and software that automatically maps tumor-feeding vessels attack the same problem from different sides: reduce off-target delivery and increase the dose reaching the lesion.<\/p>\n

Open questions remain that only practice will answer. Adding a microcatheter inside TriNav Advance may lengthen fluoroscopy time and the learning curve; compatibility with microcatheters from different manufacturers still needs to be spelled out by the company; and device cost, on top of microsphere cost, weighs on any market without a dedicated reimbursement code. For services in Brazil and across Latin America already performing TACE and TARE, the news is above all a signal of where the technique is heading: more distal selectivity, less reflux and growing pressure for individualized dosimetry.<\/p>\n

Source:<\/strong> Diagnostic Imaging<\/a> and TriSalus press release<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

FDA grants 510(k) to TriNav Advance, TriSalus’s PEDD catheter with SmartValve plus microcatheter for distal vessels in TACE and Y-90 radioembolization.<\/p>\n","protected":false},"author":1,"featured_media":19589,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"ngg_post_thumbnail":0,"_rt_cluster":"","fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[100],"tags":[],"class_list":["post-19616","post","type-post","status-publish","format-standard","has-post-thumbnail","category-radiology"],"aioseo_notices":[],"rt_seo":{"title":"","description":"FDA grants 510(k) to TriNav Advance, TriSalus's PEDD catheter with SmartValve plus microcatheter for distal vessels in TACE and Y-90 radioembolization.","canonical":"","og_image":"","robots":"index,follow","schema_type":"Article","include_in_llms":true,"llms_label":"FDA clears TriNav Advance (TriSalus) for liver embolization","llms_summary":"On September 22, 2026 TriSalus Life Sciences (Nasdaq: TLSI) announced FDA 510(k) clearance of TriNav Advance, a PEDD infusion catheter with SmartValve, in two configurations: telescoping (with a compatible microcatheter, valve proximal, for small distal vessels) and high-flow (used like a standard TriNav). Limited market release over the coming weeks. Context: retrospective (Titano, CVIR 2019) and real-world (Gupta, CMRO 2024) evidence, HCPCS code C9797 in the US, ongoing Y-90 radioembolization trials, and Brazilian coverage of radioembolization under ANS RN 542\/2022.","faq_items":[],"video":[],"gtin":"","mpn":"","brand":"","aggregate_rating":[]},"_links":{"self":[{"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/posts\/19616\/"}],"collection":[{"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/posts\/"}],"about":[{"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/types\/post\/"}],"author":[{"embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/users\/1\/"}],"replies":[{"embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/comments\/?post=19616"}],"version-history":[{"count":1,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/posts\/19616\/revisions\/"}],"predecessor-version":[{"id":19618,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/posts\/19616\/revisions\/19618\/"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/media\/19589\/"}],"wp:attachment":[{"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/media\/?parent=19616"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/categories\/?post=19616"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rtmedical.com.br\/en\/wp-json\/wp\/v2\/tags\/?post=19616"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}