FDA clears interventional device designed to improve liver embolization procedures
The U.S. Food and Drug Administration has cleared a new device that could give interventional radiologists greater access to small, distal vessels during liver embolization procedures.
Colorado-based TriSalus Life Sciences’ TriNav Advance has received 510(k) clearance with two configurations designed to accommodate differences in vessel anatomy and treatment goals. The device is intended to support the company’s pressure-enabled drug delivery approach for liver embolization, potentially allowing physicians to deliver therapy more precisely while limiting exposure to surrounding tissue.
When used with a compatible microcatheter, the device’s telescoping configuration allows the SmartValve to be positioned proximally, helping physicians deliver therapy to smaller distal vessels, according to TriSalus. For procedures requiring infusion through a larger lumen, physicians can use the device’s high-flow configuration similarly to standard TriNav devices without an additional microcatheter.
“TriNav Advance enhances our pressure-enabled drug delivery portfolio in support of the full range of liver embolization procedures,” Mary Szela, president and CEO of TriSalus, said in an announcement. “We are proud of the range of tools we offer to physicians and believe TriNav Advance will catalyze further adoption across these procedures."
“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. “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 [pressure-enabled drug delivery] clinically meaningful."
The clearance expands TriSalus’ portfolio into cases involving challenging anatomy that the company said its existing technology has not been able to fully address.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.