Medtronic is planning its first commercial renal denervation (RDN) cases and is already running a postmarket study after winning FDA approval of its Symplicity Spyral system for hypertension. In an interview before the Thanksgiving break, Medtronic SVP Jason Weidman — who’s also president of the company’s coronary and RDN business — said he expects the […]
RDN
FDA approves Medtronic’s Symplicity Spyral renal denervation system
Medtronic today announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. [Update: Read more of our coverage from the weeks following the approval, including Medtronic’s lessons learned, what’s next for the technology, and other potential applications.] A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic […]
FDA review panel: Medtronic Symplicity Spyral RDN risks outweigh benefits
An FDA review panel voted against recommending approval of Medtronic’s Symplicity Spyral renal denervation (RDN) therapy for hypertension under the proposed indications. The panel unanimously said the minimally invasive catheter system is safe, but was nearly split on efficacy. With six members voting that the benefits outweighed the risk, six voting the other way and […]