ReCor Medical touts Paradise renal denervation trial data, seeks FDA IDE for pivotal
ReCor Medical today released results from a trial of its Paradise ultrasound-based renal denervation system, touting that the trial met its primary efficacy endpoint and showed a statistically significant reduction in blood pressure in treated hypertensive patients.
Results from the trial were presented at the EuroPCR 2018 annual meeting in Paris and published in The Lancet, the Palo Alto, Calif.-based company said.
“ReCor and the investigator teams are aware of the large potential patient population who may be interested in Paradise as a device-based hypertension therapy. An early indicator of this is the more than 500,000 people who sought information about the Radiance-HTN study,” founder & COO Mano Iyer said in a prepared statement.
Data from the trial indicated that it met its primary efficacy endpoint, demonstrating a difference in ambulatory daytime systolic blood pressure changes of 6.3 mm Hg at two months with no reports of major adverse events.
Results also indicated additional improvements including office, home and 24-hour ambulatory blood pressure levels as well as the percentage of patients with controlled blood pressure at two months.
“We are pleased with the outcomes of the Radiance-HTN Solo trial. We believe that Solo was designed and conducted in a rigorous manner. In patients with mild to moderate hypertension, previously treated with up to two medications and randomized while off medications, the Paradise System reduced blood pressure in comparison to a sham control. In addition, the procedure was performed with an average ablation time of less than one minute and demonstrated a positive safety profile both acutely and at 30-day follow-up,” co-principal investigator Dr. Laura Mauri of Boston’s Brigham & Women’s Hospital said in a press release.
“The Solo investigators are satisfied with the clinical outcomes in the study. At 2-months, more than 66% of subjects treated with renal denervation experienced a 5 mmHg or greater reduction in daytime ambulatory systolic blood pressure, compared with 33% in the sham group. Radiance-HTN Solo also demonstrated a reduction in office blood pressure of 10 mmHg systolic, which if durable over time, has been shown to reduce the risk of cardiovascular diseases, including stroke and heart attack, in patients with hypertension. The Radiance-HTN research program is ongoing, with extended follow-up for the Solo patients and continued enrollment of the Trio cohort patients with resistant hypertension. Our goal is to demonstrate the effectiveness, safety, and durability of renal denervation in both important patient populations,” co-principal investigator Dr. Michel Azizi of Paris’ Hôpital Européen Georges-Pompidou said in a prepared release.
ReCor Medical also announced it submitted an IDE supplement to the FDA seeking a pivotal study of the Paradise system as it pursues indications for treating hypertension..
“We are very pleased with the progress of the Radiance program to assess the Paradise System as a potential treatment for hypertension. Given the positive results from SOLO and the high level of interest from patients in the US and Europe for device-based hypertension therapy, we are encouraged to continue our work. As Prof. Mauri is leaving her clinical position at Brigham & Women’s Hospital in Boston – and thus her role as co-PI – we have invited Prof. Kirtane to fill her role. We thank Prof. Mauri for her leadership and support during the past 3 years, and welcome Prof. Kirtane to join Prof. Azizi as co-PI,” CEO Andrew Weiss said in prepared remarks.
