FDA Sets Dates for ReCor and Medtronic Renal Denervation Panel Sessions

June 22, 2023—The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee will hold a meeting virtually on August 22-23, 2023, from 9:00 am to 6:00 pm (EDT) to discuss, make recommendations, and vote on devices indicated to reduce blood pressure in patients with hypertension.

The premarket approval application (PMA) for the Paradise ultrasound renal denervation system (uRDN, ReCor Medical, Inc.) will be the focus of the August 22 session and the PMA for the Symplicity Spyral RDN (Medtronic) will be discussed on August 23.

The FDA notification advised that the proposed indication-for-use statements for the respective devices are the following:

• “The ReCor Paradise ultrasound renal denervation system is indicated to reduce blood pressure in adult (≥ 22 years of age) patients with uncontrolled hypertension, who may be inadequately responsive to, or who are intolerant to, antihypertensive medications, which is intended to be used in renal arteries of diameters ranging from 3.0 to 8.0 mm.”
• “The Symplicity Spyral multielectrode renal denervation catheter and the Symplicity G3 RF generator are indicated for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of antihypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.”

More meeting details and submission instructions are available in the FDA notification, which was issued on June 12, 2023, by Lauren K. Roth, Associate Commissioner for Policy.

According to the FDA notification, the meeting will be open to the public. All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform.

The FDA intends to make background material available to the public no later than 2 business days before the meeting. Background material and the link to the online teleconference meeting room will be available online at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee as follows:

• Written submissions may be made to the FDA’s contact person on or before August 1, 2023.
• Requests to make oral presentations must be submitted on or before July 24. Individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested.

Oral presentations from the public will be scheduled on August 22 and 23, 2023, between approximately 1:30 pm and 2:30 pm (EDT). Time allotted for each presentation may be limited.

The FDA’s contact person is Jarrod Collier at Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002; email, Jarrod.Collier@fda.hhs.gov; phone, 240-672-5763. Or, call the FDA Advisory Committee Information Line, 1-800-741-8138.

On November 29, 2022, ReCor Medical and its parent company, Otsuka Medical Devices Co., Ltd., announced the filing of the PMA application for the Paradise uRDN system. Paradise has received CE Mark approval for the treatment of hypertension in Europe. It is an investigational device in the United States and Japan, advised the company.

In a June 22, 2023, statement from Medtronic, the company noted that the Symplicity Spyral RDN system has been evaluated in the SPYRAL HTN Global Clinical Program for more than 10 years in more than 4,000 patients. The device is approved for commercial use in more than 60 countries. It is currently limited to investigational use in the United States, Japan, and Canada.

Jason Weidman, Senior Vice President and President of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic, commented in the statement, “We welcome the opportunity to share evidence from our extensive, global clinical program, which includes multiple sham-controlled studies supporting the use of renal denervation at the upcoming Circulatory System Devices Panel. This will also allow us to share Medtronic’s long-term data around the Symplicity blood pressure procedure to the panel members and underscore our commitment to bringing this important solution to millions of people in the United States who suffer from uncontrolled high blood pressure.”