Medtronic and Recor Medical may have some fresh resolutions for the new year after the Centers for Medicare & Medicaid Services (CMS) recently approved reimbursements for the two companies’ respective renal denervation systems, effective Jan. 1, 2025.
CMS handed down separate transitional pass-through payments to each developer, granting distinct category and device codes (PDF) to their outpatient procedures for reducing stubbornly high blood pressure that has not responded to medications. The TPT payments are expected to last for up to three years.
The program aims to help Medicare beneficiaries access treatments with new and recently approved technologies while CMS gathers additional data toward more permanent reimbursement coverage.
Both Medtronic’s Symplicity Spyral and Recor’s Paradise renal denervation catheters were greenlighted by the FDA in November of last year, following more than a decade of research and development in what the companies estimate could become a multibillion-dollar enterprise.
Recor, now a division of Otsuka Medical Devices, first began working on its Paradise system in 2009. The ultrasound-powered device uses the vibrations to generate heat that disables the nerves lining the main blood vessels leading to the kidneys, which can trigger the brain to increase the body’s blood pressure.
“TPT for ultrasound renal denervation increases access to a proven device-based hypertension treatment option to patients who have been unable to achieve blood pressure control with lifestyle changes and medications alone,” Recor President and CEO Lara Barghout said in a statement. “By creating a distinct device category, CMS have also recognized that the Paradise uRDN system is a highly differentiated technology and that there are significant differences in comparison to other technologies available in the marketplace.”
Medtronic, meanwhile, with its radiofrequency ablation approach, previously had setbacks in clinical trials more than 10 years ago before seeing study success with a redesigned device in 2020. But, in addition, last year an FDA panel of outside advisers narrowly voted to not recommend approval for Symplicity Spyral while instead backing Recor’s system.
But the medtech giant stuck with it—and, late last month, the company presented clinical data showing that the one-time Symplicity procedure could still provide durable reductions in blood pressure out to two years, even among patients on an anti-hypertensive regimen of as many as three different drugs.
At the TCT conference in Washington, D.C., the sham-controlled trial demonstrated a 5.7-mmHg drop in 24-hour ambulatory systolic blood pressure readings as well as a 8.7-mmHg drop when measured in a doctor’s office.
“Receiving TPT approval for our [renal denervation] catheter is an important milestone for the Symplicity blood pressure procedure, as it will enable greater patient access to a breakthrough treatment by reducing cost barriers for healthcare systems,” said Jason Weidman, president of Medtronic’s coronary and renal denervation business.
“Very few technologies achieve this qualification, and the core goals of fostering innovation and increasing access mirror Medtronic's desire to continue bringing Symplicity to even more patients suffering from uncontrolled high blood pressure,” Weidman added.
Elsewhere, Medtronic said it plans to study Symplicity’s use in multiorgan denervation, including within the liver’s hepatic artery.