PALO ALTO, California, May 23, 2018 /PRNewswire/ -- ReCor Medical announced today that the RADIANCE-HTN SOLO study met its primary efficacy endpoint and demonstrated a statistically significant reduction in blood pressure in hypertensive patients. In addition, the company announced submission of an IDE supplement to the US FDA for a pivotal study of its Paradise System for the treatment of hypertension, and that Prof. Ajay Kirtane of New York-Presbyterian Hospital/Columbia University has taken the role of Co-Principal Investigator for RADIANCE-HTN.
Data presented at EuroPCR 2018, with simultaneous publication in The Lancet, showed that RADIANCE-HTN SOLO met its primary efficacy endpoint. SOLO demonstrated a difference in ambulatory daytime systolic blood pressure changes between treatment and sham at 2 months of -6.3 mm Hg (p-value of 0.0001) with no major adverse events. Additional endpoints including office, home, and 24-hour ambulatory blood pressure levels, and the percentage of patients with controlled blood pressure at 2 months were also improved in the Paradise group relative to sham.
"We are pleased with the outcomes of the RADIANCE-HTN SOLO trial," commented co-Principal Investigator Prof. Laura Mauri, Brigham & Women's Hospital, Boston, USA. "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."
Prof. Michel Azizi, Hôpital Européen Georges-Pompidou, Paris, France, Co-PI, commented, "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."
"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," commented Founder & COO, Mano Iyer.
ReCor also announced today that the company submitted a new protocol to the US FDA for a pivotal study: an independently-powered, sham-controlled, efficacy study of the Paradise System in patients with 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," commented CEO Andrew M. Weiss. "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."
About ReCor Medical, Inc.
ReCor Medical is a private, development-stage, medical device company with the Paradise® System, a proprietary, ultrasound-based system for endovascular denervation of the renal nerves (RDN). RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions. The Paradise System bears a CE mark but is not approved for sale in the United States. ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe. The RADIANCE-HTN SOLO trial is a randomized, sham-controlled, and blinded study of 146 hypertensive patients temporarily withdrawn from their hypertension medications, comparing the ReCor Paradise ultrasound-based Renal Denervation System to a sham procedure.
SOURCE ReCor Medical