ARTICLE SUMMARY:
In November, FDA approved renal denervation systems from Medtronic and Recor Medical as adjunctive treatments for people with hypertension. The label is broad, and the technology addresses a huge unmet need, but just how far, and how fast, will this new device market go?
After more than a decade of effort and angst, renal denervation (RDN), a percutaneous device-based treatment for hypertension, has finally reached the US market. In November, FDA approved RDN systems from Recor Medical (a subsidiary of Otsuka Medical Devices) and Medtronic in fairly rapid succession, with Recor’s Paradise Ultrasound Renal Denervation balloon catheter system receiving the green light on November 7, followed 10 days later by Medtronic’s Symplicity Spyral multi-electrode radiofrequency catheter system. Both companies launched almost immediately, with initial commercial procedures taking place at several centers across the US in November.
The FDA labeling is broad; the systems are both indicated for use as an adjunctive treatment to reduce blood pressure in hypertension patients who fail to achieve adequate blood pressure control with lifestyle modifications and antihypertensive drugs. And analysts consider the wide label a big win for the RDN field, which has been beset for years by questions about the magnitude and durability of the treatment effect and appropriate patient selection criteria, among other things. (See “Renal Denervation: Poised for a Comeback?” MedTech Strategist, July 13, 2021.)
But while this is a potentially multibillion-dollar market opportunity—and many interventional cardiologists seem eager to add RDN to their toolboxes—the initial US rollout is likely to be slow and measured, as both Recor and Medtronic face logistical and reimbursement hurdles that will temper widespread use.
