Despite Concerns About Effect Durability Panel Supports ReCor’s Hypertension Device

An FDA advisory panel has endorsed ReCor Medical’s novel ultrasound renal denervation system, agreeing unanimously that it’s safe for use in adults with uncontrolled or inadequately controlled hypertension, although the 12 voting members disagreed about how effective the ReCor Paradise system will be in the long run.

Three members of the Circulatory System Devices Panel said that none of the company’s three sham-controlled studies showed that the Paradise system exerts any long-lasting benefit on hypertension.

Although the product did reduce systolic blood pressure by about 5 mmHg in the first two months — a significant difference relative to the sham treatment — that difference wasn’t maintained at six months. And six months after the procedure, everyone in both the active and sham groups was taking just one less blood pressure medication than at the start of the study.

Panel Chair Richard Lange of Texas Tech University Health Sciences Center, El Paso, summed up his colleagues’ feelings on how well the Paradise device works by saying “It’s not superior to medication. ... There’s an acute decrease in blood pressure but it’s not clear if the device offers any long-term benefit in terms of BP reduction.”

The panel agreed that the benefit of Paradise was quite modest, on the order of what one might expect with the addition of one extra antihypertensive medication.

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