The US Food and Drug Administration (FDA) Circulatory Systems Devices Panel met yesterday (23 August) to review evidence of the safety and efficacy of Medtronic’s Symplicity Spyral renal denervation system, with committee members split on the motion that the benefits of the device outweigh the risks for use in patients with hypertension.
The Circulatory Systems Devices Panel is designed to review and evaluate data regarding the safety and effectiveness of devices for use in the circulatory and vascular systems and make appropriate recommendations to the FDA commissioner. The panel recommendation will be considered by the FDA as it continues to review the Medtronic Symplicity Spyral system for US market approval.
The Panel was meeting for a second consecutive day after having examined similar evidence for the Paradise (Recor Medical) ultrasound renal denervation system at a meeting broadcast online on Tuesday (24 August). At that meeting, the committee voted 12 to 0 in favour of the Paradise ultrasound renal denervation system with regard to safety and eight to three in favour with regard to efficacy, with one vote abstaining. The committee also voted 10 to two in favour that the Paradise system benefits outweigh the risks.
At yesterday’s meeting, concerning the Symplicity Spyral system, the panel committee voted unanimously (13‒0) on safety, and with seven votes to six in favour of the effectiveness of the Symplicity blood pressure procedure. But, the committee’s vote was closely divided on the benefit/risk profile of the device, tied at six votes each way with one abstention. The panel’s chair, Richard Lange (Texas Tech University Health Sciences Center El Paso, El Paso, USA) broke the tie, resulting in a final six‒seven ‘no’ vote.
“We appreciate the robust conversation that occurred prior to the vote,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. “We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure.”
“The Symplicity Blood Pressure Procedure has the potential to fill a significant unmet need in hypertension care, and we know patients are looking for options in addition to medication and lifestyle modifications to manage their blood pressure,” said David Kandzari (Piedmont Heart Institute, Atlanta, USA) and lead principal investigator of the SPYRAL HTN-ON MED clinical trial. “The totality of evidence demonstrated that there is a benefit with the Spyral renal denervation catheter, and there is no question about the safety of the procedure.”
The Medtronic SPYRAL HTN Global clinical programme has studied renal denervation for more than 10 years and in more than 4,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk.
The Symplicity blood pressure procedure has demonstrated sustained and durable drops in blood pressure out to three years in randomised control and real-world registry trials, Medtronic said in a press release.
The device is currently approved for commercial use in 70 countries, but is limited to investigational use in the USA, Japan, and Canada.