Medtronic’s Renal Denervation System for Hypertension Splits FDA Panel
A radiofrequency-based renal denervation system for uncontrolled hypertension got a cool reception from FDA advisors who nevertheless left the door open for regulatory approval. On Wednesday, the FDA’s Circulatory System Devices Panel voted 6-7 (with one abstention) that the benefits of the Symplicity Spyral multi-electrode catheter system do not outweigh its risks when used to […]
FDA Panel Backs ReCor’s Renal Denervation System for Hypertension
The Paradise ultrasound renal denervation system got backing from the FDA’s Circulatory System Devices Panel as a possible treatment for hypertension, as manufacturer ReCor continues to hope for regulatory approval. On Tuesday, FDA advisors voted 10-2 that the benefits of the Paradise catheter-based system outweigh its risks when used to reduce blood pressure (BP) in […]