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The FDA's Circulatory Systems Devices Panel of the Medical Devices Advisory Committee backed Recor Medical Inc and its parent company, Otsuka Medical Devices Co Ltd's (OTC:OTSKF) (OTC:OTSKY) hypertension (high blood pressure) treatment.
During the committee's session, a favorable sentiment emerged, indicating that the available data sufficiently supported using the Paradise Ultrasound RDN system in individuals with uncontrolled hypertension.
The Paradise Renal Denervation System is a minimally invasive procedure to treat overactive nerves leading to the kidney.
A small incision is made in the groin. A small flexible catheter is inserted and placed in the artery supplying the kidney.
Ultrasound energy (sound waves) is delivered to the tissue surrounding the artery for several seconds. The ultrasound energy generates heat to decrease the over-activity of the nerves leading to the kidney.
The panel's unanimous vote of 12 to 0 was cast in favor of the device's safety, while a majority vote of 8 to 3 favored its efficacy. An additional favorable outcome emerged from the committee's vote of 10 to 2, indicating that the benefits of the Paradise system outweighed the associated risks.
Should the FDA grant approval, the Paradise Ultrasound RDN system would potentially become the first FDA-approved renal denervation device in the U.S. intended to reduce blood pressure in patients with uncontrolled hypertension.
Panel members recommended that the device be used as a possible add-on therapy to reduce blood pressure, not as a medication replacement.
The Paradise Ultrasound RDN system is available in Europe for hypertension treatment and holds investigational device status in the United States and Japan.
