RADIANCE-HTN SOLO study with Paradise renal denervation system meets primary endpoint in hypertension.- ReCor Medical.

ReCor Medical announced that the RADIANCE-HTN SOLO study with the Paradise renal denervation system 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. Data 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. Data were presented at EuroPCR 2018, with simultaneous publication in The Lancet.

See: Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial.