ReCor Medical this week announced that its Paradise ultrasound renal denervation system won FDA breakthrough device designation following positive results in a study.
The Palo Alto, Calif.-based company’s Paradise system is an investigational device that is designed to treat hypertensive patients who may not be sufficiently responsive to or are tolerant of anti-hypertensive medical therapy. It is a catheter-based system that denervates the renal nerves with ultrasound energy to reduce blood pressure in hypertensive patients.