Recor Medical has followed up its US Food and Drug Administration (FDA) approval of its Paradise ultrasound renal denervation system earlier this year with positive results from a six-month follow-up of its RADIANCE trials.
The pooled analysis, which is from three studies in the RADIANCE programme, covered 506 patients. Patients in the RADIANCE-HTN TRIO had resistant hypertension, and patients in the RADIANCE-HTN SOLO and RADIANCE II trials had mild to moderate forms of the disease.
The results were presented at a late-breaking session at the Transcatheter Cardiovascular Therapeutics (TCT) conference held in San Francisco from 23-26 October 2023.
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Recor Medical stated that after the two-month primary endpoints in the trials, patients were given antihypertensive treatments if their home blood pressure went too high. The analysis demonstrated that fewer of these treatments were administered at six months in the groups that underwent renal denervation compared to the sham groups.
The ultrasound renal denervation groups had 3mmHg lower daytime ambulatory systolic blood pressure when adjusted for medication differences. Office and home systolic blood pressure were also 5.4mmHg and 5.2mmHg lower over the six months.
RADIANCE co-principal investigator Dr Ajay Kirtane said: “One of the key questions often asked about renal denervation is whether it is durable, especially in comparison to (or in combination with) antihypertensive medications.”
