Paradise™Ultrasound-Based Renal Denervation System Shows 6 Month 33mmHg BP Reduction In Resistant Hypertension Patients

In short

Renal Denervation is one of the hottest topics in medical devices at the moment and German outfit ReCor Medical has been in the fray with its announcement of CE marking for its Paradise™ system earlier this year (details here). Now the company has reported six-month follow-up data on eight patients who have been treated via renal denervation for their resistant hypertension with the company’s unique ultrasound-based system.

Background

ReCor Medical claims its Paradise ultrasound catheter was designed with the aim to allow complete circumferential denervation more consistently and efficiently than the standard of care radiofrequency ablation catheter. The procedure with the Paradise system only requires 30 seconds of energy delivery per treatment location, thereby dramatically reducing the overall procedure time.

The scientific literature demonstrates that a 5 mmHg reduction in blood pressure results in a 14% decrease in stroke, a 9% decrease in heart disease, and a 7% decrease in mortality. In the 8 patient ReCor study, at six months follow-up, the Paradise data showed that office systolic blood pressure was reduced by an average of 33 mmHg in 8 patients. There were also significant and sustained blood pressure reductions in home and ambulatory measurements at six months.

Company comments

“These clinical results strongly suggest a significant competitive advantage for ReCor’s ultrasound-based PARADISE system compared to radiofrequency-based standard of care for treating resistant hypertension patients,” said Mano Iyer, CEO, ReCor Medical.

We say

We’re not sure how ReCor’s CEO can claim comparative superiority against radiofrequency based systems, unless he has data he’s not sharing in this news release, but regardless of that these are impressive findings with real clinical significance if it translates into the real world.

Regulatory status

Paradise is approved for sale in Europe. It is not approved for sale or investigational use in the United States.

Source: ReCor Medical, Inc., Business Wire