TriNav receives CMS approval for transitional pass-through payment status


TriSalus Life Sciences (formerly Surefire Medical) has announced that the Centers for Medicare and Medicaid Services (CMS) granted approval for transitional pass-through (TPT) payment for its Surefire Spark Infusion System. Effective 1 January 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 1 November 1 2019.

TriNav is designed to improve therapeutic distribution and penetration into solid tumors. 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.

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,” says 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 favourable reimbursement status validates our innovative delivery system and confirms its role in our unique, multi-pronged approach to treat liver metastases and pancreatic cancer.”


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