DENVER, Colo. (247marketnews.com) -- TriSalus Life Sciences (NASDAQ:TLSI) cleared a regulatory hurdle that could materially broaden the reach of its Pressure-Enabled Drug Delivery platform.
TriSalus announced that the FDA granted 510(k) clearance for TriNav Advance, its newest PEDD device. The significance is straightforward: the new system is designed to extend PEDD delivery into smaller, more distal vessels through a compatible microcatheter, potentially giving interventional radiologists another tool for anatomies and procedures that the existing TriNav portfolio could not address as broadly.
TriSalus CEO Mary Szela called the clearance a way to support “the full range of liver embolization procedures” and said the company believes the new device can help catalyze further adoption of its technology. Chief Medical Officer Richard Marshall described the clearance as a “seminal moment” that could extend PEDD into cases involving tortuous anatomy.
TriSalus spent 2026 building the commercial infrastructure needed to push beyond its existing installed base. Second-quarter revenue reached $11.4 million, while the company maintained 2026 revenue guidance of $54 million to $57 million. The company also reported an 86.8% gross margin for the quarter.
The FDA decision removes an important piece of uncertainty that had been hanging over that expansion strategy. In May, TriSalus specifically cited the timing of TriNav Advance clearance when it revised its 2026 revenue outlook
TriSalus reported in May that a real-world analysis involving 603 PEDD patients and 16,210 non-PEDD patients found an association between PEDD use and fewer post-procedure complications, reduced hospitalizations and approximately $7,700 in per-patient charge avoidance, despite greater baseline clinical complexity among PEDD patients. Those findings are observational and do not establish that PEDD caused the reported differences, but they add to the evidence base the company is using to support broader adoption.
The company has also launched the PREDICTT clinical trial at MD Anderson Cancer Center to prospectively evaluate PEDD with Y-90 radioembolization in patients with primary or metastatic liver tumors.
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