TriSalus™ Life Sciences’ Surefire® Spark™ Infusion System (TriNav™) Receives CMS Approval for Transitional Pass-Through Payment Status
Designed to improve therapeutic distribution and penetration in solid tumors
DENVER, CO, November 20, 2019 — TriSalus™ Life Sciences (formerly Surefire Medical Inc.), a company committed to treating cancer at its origins, today announced that the Centers for Medicare & Medicaid Services (CMS) granted approval for transitional pass-through (TPT) payment for its Surefire® Spark™ Infusion System. Effective January 1, 2020, Surefire® Spark™ Infusion System (to be known as TriNav™) was granted transitional pass-through payment status as part of the 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System (CMS-1717-FC) final rule posted on November 1, 2019.
This additional payment is intended to “facilitate access for [Medicare] beneficiaries to the advantages of new and truly innovative devices”*. The Surefire® Spark™ Infusion System met the required criteria to receive transitional pass-through status, with the CMS saying it believes there is no existing pass-through payment category for this device because of its Pressure-Enabled Drug Delivery™ (PEDD™) valve, which offers a unique mechanism for therapy delivery to selected sites in the peripheral vascular system, including solid tumors in the liver and pancreas.
“We thank CMS for its efforts to expand access to devices such as our Surefire® Spark Infusion System that provide improved benefits to patients,” said Mary Szela, President and CEO of TriSalus . “As we transform TriSalus™ into an oncology therapeutics focused company dedicated to improving outcomes in solid tumors, this highly favorable reimbursement status validates our innovative delivery system and confirms its role in our unique, multi-pronged approach to treat liver metastases and pancreatic cancer.”
About the Surefire® Spark™ Infusion System
The Surefire® Spark™ Infusion System (to be known as TriNav™) is a flexible, ultra-thin microcatheter with a self-expanding, nonocclusive one-way microvalve at the distal end. This system, using Pressure-Enabled Drug Delivery™ technology, has demonstrated the ability to overcome intratumoral pressure in solid tumors and potentially improve distribution and penetration of therapy during Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Radioembolization (TARE) procedures. About Pressure-Enabled Drug Delivery™ (PEDD™) The Pressure-Enabled Drug Delivery™ (PEDD™) is a self-expanding, nonocclusive, one-way valve that infuses therapeutics into a solid tumor at a pressure higher than the baseline mean arterial pressure, and this pressurized delivery opens up collapsed vessels in tumors and enables perfusion and therapy delivery into hypoxic areas of solid tumors.
TriSalus™ is dedicated to improving patient outcomes in pancreatic and other highly intractable solid tumors. TriSalus™ has the potential to deliver novel therapeutic agents and immuno-stimulants directly into tumors’ vasculature using a proprietary enabling Pressure-Enabled Drug Delivery™ (PEDD™) technology to improve the distribution and penetration of therapy in solid tumors. This innovative approach has the potential to allow for the administration of multiple mechanisms that can work together to overcome inherent immune suppression within the solid tumor microenvironment. For more information, please visit www.trisaluslifesci.com.