TriSalus Life Sciences, Inc. (Nasdaq: TLSI) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TriNav Advance. The clearance expands the company’s Pressure-Enabled Drug Delivery™ (PEDD™) portfolio. TriSalus Life Sciences develops oncology technologies for patients with solid tumors. The company combines novel delivery technology with standard-of-care therapies. It also works with its investigational immunotherapeutic treatments.
The FDA clearance adds TriNav Advance as the newest device in the company’s PEDD portfolio. The device expands access to small and distal vessels through a compatible delivery microcatheter. At the same time, it preserves the enhanced therapeutic delivery and off-target protection associated with PEDD. Furthermore, interventional radiologists can pair TriNav Advance with a compatible microcatheter of their choice. This approach provides greater flexibility across different procedures and anatomical situations.
“TriNav® Advance 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.”
TriNav Advance Expands Embolization Options
With TriNav Advance, TriSalus Life Sciences now offers a broader PEDD device portfolio. The portfolio addresses liver-directed therapy cases across different treatment needs. In addition, the device indication supports a wider range of embolization procedures beyond the liver. This broader indication can support physicians across additional treatment settings. The company plans to begin a limited market release of TriNav Advance in the coming weeks. The launch will introduce the device to selected users before broader availability.
TriNav Advance supports two configurations based on vessel anatomy and treatment goals. Each configuration offers a different approach for delivering therapy. The first option uses a telescoping configuration. Physicians can use TriNav Advance with a compatible microcatheter. In this setup, the TriNav Advance SmartValve sits proximal to the delivery site. This configuration enables selective delivery into smaller, distal vessels. It also maintains the benefits associated with Pressure-Enabled Drug Delivery.
The second option uses a high-flow configuration. Physicians can use it similarly to a standard TriNav device. This setup does not require an additional microcatheter. Instead, physicians can infuse therapy through the device’s large lumen. Therefore, the configuration provides a straightforward option for high-flow delivery needs.
TriSalus Highlights PEDD Technology
The FDA clearance also expands the potential application of TriSalus’ PEDD technology. The company sees opportunities to address procedures involving more challenging vessel anatomies.
Consequently, TriNav Advance may provide physicians with additional options during complex embolization procedures. The device also extends the company’s existing approach to therapeutic delivery.
Device Targets Challenging Anatomies
Richard Marshall, M.D., Chief Medical Officer of TriSalus, highlighted the importance of the FDA clearance.
“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, M.D., 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.”
The company expects TriNav Advance to complement its existing PEDD devices. The expanded portfolio can support different vessel sizes and procedural requirements. Moreover, the device gives interventional radiologists more flexibility during liver embolization procedures. Physicians can select the configuration that aligns with vessel anatomy and treatment objectives.
TriSalus Life Sciences continues to develop solutions focused on oncology treatment delivery. Its PEDD technology remains a central part of that strategy. With the new FDA clearance, TriNav Advance adds another option to the company’s drug delivery platform. The planned limited market release will mark the next stage of its commercial rollout.
Overall, the addition strengthens TriSalus Life Sciences’ portfolio for liver-directed therapy. It also broadens the potential use of PEDD across embolization procedures involving complex anatomical conditions.
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News Source: Businesswire.com
