Medtech Insight caught up with Sean Salmon, the president of Medtronic's cardiovascular business, to talk about the long-awaited FDA approval of the Symplicity Spyral renal denervation system, recent approvals of the PulseSelect pulsed field ablation system and extravascular ICD, and the company's plans for transcatheter aortic valve replacement.

The US FDA approved ReCor’s Paradise ultrasound renal denervation system, making it the first RDN system to reach the US market. Medtronic hopes its Symplicity Spyral radiofrequency RDN system will be the second RDN system on the US market, but it may face a more difficult path through the approval process.

The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.

FDA’s circulatory system advisory panel narrowly voted against Medtronic’s Symplicity Spyral, because one of the pivotal trials of the radiofrequency renal denervation system missed its primary endpoint and the patient population evaluated in the trial does not match the requested indication.