TriSalus, a Denver, Colorado firm, is launching a new solid tumor infusion system to target hepatocellular carcinoma, liver metastases, and other tumors. The TriNav Infusion System features the company’s SmartValve and Pressure-Enabled Drug Delivery (PEDD) technologies to get more of the tumor killing drug inside the diseased tissue. The treatment is delivered in a similar manner as many existing intravascular procedures, as the device is compatible with common cath lab tools (0.035-inch and 0.038-inch standard angiographic catheters) and is easy to track through the vasculature because of a single-body design. Getting a drug into a solid tumor is a challenge because the tumor pushes back with its own pressure, limiting how much it is willing to uptake. The TriNav system generates a pressure gradient that is stronger than regular blood flow, to push a drug into the tumor. A special valve called SmartValve helps to make sure that the drug delivery is aimed toward the tumor, sparing healthy tissues that would be susceptible to its toxic effects. “Tumor-directed delivery of therapeutics is an exciting opportunity to help improve outcomes across a wider range of procedures by overcoming intratumoral pressure that can prevent drugs from adequately penetrating the tumor,” said Mary Szela, President and CEO of TriSalus, in the announcement. “The new TriNav Infusion System utilizes SmartValve™, a first-in-kind, proprietary technology that has been shown to modulate pressure and flow with the goal for improved therapeutic delivery and deeper penetration into the tumor while helping to protect healthy tissue.” Here’s some info about a recent study of the technology, according to TriSalus: In a clinical study, PEDD with SmartValve demonstrated the ability to overcome tumor infusion barriers and significantly improve response rates in HCC. Outcomes from a retrospective, single-center study of patients with solitary HCC tumors who underwent treatment utilizing either PEDD or standard end-hole microcatheters, showed 100% Objective Response (OR) with PEDD versus 76.5% with standard end-hole microcatheters (p=0.019). Additionally, after first treatment, Pathological Response (PR) as shown by tumor necrosis percentage was significantly greater with PEDD (88.8%) vs. standard end-hole microcatheters (33.8%), (p=0.026). Improving response rates could potentially help more patients meet transplant criteria, lead to successful downstaging, bridging, and post-transplant survival. Source
