Is FDA Approval for Renal Denervation on the Horizon?
On August 22-23, 2023, the FDA will conduct an Advisory Committee Meeting to discuss, make recommendations, and vote on renal denervation devices (e.g., devices indicated to reduce blood pressure in patients with hypertension). On August 22, the Advisory Committee will discuss the Paradise Ultrasound Renal Denervation System by ReCor Medical, a wholly-owned subsidiary of Otsuka Medical Devices Co., Ltd. The following day, the Advisory Committee will discuss the Symplicity Spyral Renal Denervation System by Medtronic, Inc.. According to the FDA’s meeting announcement, such advisory committees “make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.”
The FDA’s meeting will be conducted virtually and will be open to the public. The FDA intends to make background material available to the public at least two business days before the meeting. Background material and the link to the online teleconference meeting room will be posted to the FDA’s website.
This meeting comes on the heels of a recent recommendation made by the European Society of Hypertension (ESH) during its 32nd annual scientific meeting in late June. Specifically, the ESH recommended that, under certain conditions, renal denervation be offered as an additional therapy to patients with hypertension. The ESH recommendation comes after a similar recommendation from the European Society of Cardiology earlier this year.
Medtronic issued a press release shortly after the ESH recommendation. Jason Weidman, Senior Vice President and President of the Coronary and Renal Denervation business at Medtronic, remarked:
Several other companies are also seeking FDA approval for renal denervation systems. For example, Sonivie received investigational device exemption (IDE) approval for its Therapeutic Intra-Vascular Ultrasound (TIVUS) System in 2022 and Metavention announced on June 21, 2023 that it received IDE approval to initiate a pivotal study on its integrated radiofrequency renal denervation system.