The US Centers for Medicare & Medicaid Services (CMS) has granted Medtronic plc, a global healthcare technology leader, transitional pass-through (TPT) payment status for its Symplicity Spyral renal denervation (RDN) catheter. This recognition, under the Medicare Hospital Outpatient Prospective Payment System, is set to be effective from January 1, 2025, for up to three years, facilitating patient access to this innovative technology.

Key Milestone in Patient Access

Medtronic emphasized that this TPT approval is pivotal for enabling broader access to the Symplicity Spyral system, which has shown potential in managing uncontrolled high blood pressure through the use of minimally invasive RDN procedures. Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business at Medtronic, noted that very few technologies achieve TPT status, underscoring the company’s commitment to pioneering healthcare solutions.

Addressing the Global Hypertension Crisis

Hypertension, a leading risk factor for heart attacks, strokes, and deaths, continues to be a significant health issue, particularly among underserved U.S. populations. Despite existing treatments, control rates remain suboptimal, reinforcing the need for supplementary therapies such as the Symplicity Spyral RDN catheter to improve blood pressure management.

TPT Program and Its Impact on Innovation

The TPT program aims to support hospitals in adopting new, innovative medical technologies by providing additional payments that help offset costs. This move by CMS enables quicker access for Medicare beneficiaries, bridging the gap between FDA approval and widespread availability.

The Symplicity Spyral RDN Procedure

Approved by the FDA in November 2023, the Symplicity Spyral RDN system is a minimally invasive treatment that uses radiofrequency energy to target and calm overactive nerves near the kidneys, which can contribute to persistent high blood pressure. The catheter is inserted into the renal artery, delivers controlled energy, and is removed without leaving any implants.

Backed by Comprehensive Clinical Studies

Medtronic’s SPYRAL HTN Global Clinical Program, the most extensive research initiative in this field, supports the TPT approval. This program investigates the efficacy of RDN with and without medication in patients with varying cardiovascular risks. The technology is already commercially available in over 75 countries and has been used in over 25,000 patients globally.

  CMS, FDA, Jason Weidman, Medicare, Medtronic, renal denervation, SPYRAL HTN Global Clinical Program, Symplicity Spyral