Medtronic plc, a global healthcare technology leader, recently received transitional pass-through (TPT) payment approval from the Centers for Medicare & Medicaid Services (CMS) for their Symplicity Spyral™ renal denervation (RDN) catheter. This approval is a significant milestone for the Symplicity™ blood pressure procedure and aims to improve patient access to innovative treatments by reducing cost barriers for healthcare systems.
High blood pressure, also known as hypertension, is a leading cause of heart attacks, strokes, and death. Despite available medications and lifestyle changes, many patients struggle to control their blood pressure. The approval of the Symplicity Spyral RDN System by the U.S. Food and Drug Administration (FDA) in November 2023 offers a minimally invasive procedure to help manage high blood pressure. This system delivers radiofrequency energy to nerves near the kidneys, which can contribute to hypertension.
The TPT program is designed to support access to newly approved innovative technologies by providing additional payments to hospitals to cover their costs. This program aims to reduce barriers for Medicare beneficiaries to access critical healthcare innovations shortly after FDA approval. The Medtronic SPYRAL HTN Global Clinical Program supports the TPT approval by studying RDN in patients with varying cardiovascular risks and medication statuses.
Medtronic’s mission is to alleviate pain, restore health, and extend life by delivering innovative technologies that transform lives. With over 95,000 passionate employees across more than 150 countries, Medtronic is dedicated to solving the most challenging health problems facing humanity. The Symplicity Spyral RDN System is approved for commercial use in over 75 countries and has treated more than 25,000 patients worldwide.
In conclusion, the TPT approval for the Medtronic Symplicity Spyral RDN catheter is a significant advancement in improving patient access to innovative treatments for high blood pressure. This approval underscores Medtronic’s commitment to fostering innovation and increasing access to life-changing technologies for patients worldwide.
