Medtronic, Recor Medical Get Medicare Coverage For Renal Denervation

Medtronic and Recor Medical have both been handed big wins by Medicare & Medicaid Services (CMS) in the form of approval for reimbursements for their renal denervation (RDN) technologies.

The CMS issued individual transitory pass-through payouts to each developer, assigning unique category and device numbers (PDF) for their outpatient treatments aimed at managing resistant hypertension. The TPT payments are anticipated to continue for a duration of up to three years.

While CMS collects additional information targeting more permanent payment coverage, the program’s objective is to assist Medicare beneficiaries in gaining access to therapies that use newly authorized technology.

Following over 10 years of research and development, the Food and Drug Administration (FDA) gave its approval to both the Symplicity Spyral and the Paradise renal denervation catheters manufactured by Medtronic and Recor, respectively, in November 2023. Both firms believe that their respective products have the potential to become multibillion-dollar assets.

2009 saw the beginning of Recor’s development of its Paradise system, which is now a part of Otsuka Medical Devices. Through the use of vibrations, the ultrasound-powered device generates heat that inhibits the nerves that line the major blood veins that connect to the kidneys. This, in turn, may cause the brain to raise the blood pressure throughout the body.

“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 stated.

She added that by establishing a unique device category, CMS acknowledges the Paradise uRDN system as a distinctly advanced technology, setting it apart from other solutions currently available on the market.

Medtronic, using its radiofrequency ablation technique, had challenges in clinical trials over a decade ago until achieving successful outcomes with a re-engineered device in 2020. Additionally, last year, an FDA panel of external advisors narrowly decided against recommending clearance for Symplicity Spyral, while endorsing Recor’s technology instead.

However, the medtech giant remained committed, and late last month, the company revealed clinical data indicating that the one-time Symplicity process could still yield sustained reductions in blood pressure for up to two years, even in patients undergoing an antihypertensive regimen involving as many as three distinct medications.

During the TCT meeting in Washington, D.C., the sham-controlled experiment exhibited a 5.7-mmHg reduction in 24-hour systolic blood pressure measurements and an 8.7-mmHg decrease when assessed in a clinical setting.

Jason Weidman, who heads the firm’s coronary and renal denervation division, stated that obtaining TPT approval for their renal denervation catheter marks a significant achievement for the Symplicity blood pressure procedure. He explained that this approval will enhance patient access to this groundbreaking treatment by lowering financial obstacles for healthcare systems.

Weidman added that only a limited number of technologies attain this qualification, and the primary aims of promoting innovation and expanding access align with Medtronic’s commitment to making Symplicity available to more patients struggling with uncontrolled high blood pressure.