Safety and efficacy of extravascular renal denervation using HyperQure™ renal denervation system in short-term swine model of hypertension

Abstract

This study investigated the safety and efficacy of the HyperQure (TM) extravascular renal denervation (RDN) system in a swine model of mild hypertension. Ten female pigs were fed a 3% salt diet to induce hypertension and underwent either extravascular RDN using the HyperQure (TM) RDN system (n = 7) or a sham procedure (n = 3). Blood pressure (BP) was continuously monitored using implanted transmitters, and safety assessments were conducted via computed tomography angiography (CTA) at 28 days post-procedure. The primary endpoint was the change in systolic blood pressure (SBP) at four weeks, while secondary endpoints included changes in diastolic BP (DBP), mean arterial pressure (MAP), and histological evaluation of renal nerve and artery integrity. At four weeks, SBP decreased by 11.8 +/- 5.2 mmHg in the RDN group compared to an increase of 6.4 +/- 4.2 mmHg in controls, resulting in a mean difference of 18.2 mmHg (p < .05). Similar improvements were observed in DBP and MAP, with mean differences of 15.4 and 16.2 mmHg, respectively (both p < .05). CTA revealed no significant renal artery or intraperitoneal organ injury. Histological analysis confirmed effective nerve ablation, as evidenced by reduced tyrosine hydroxylase staining, without intimal damage. No postoperative complications were observed during the 28-day study period. These findings demonstrate the safety and efficacy of the HyperQure (TM) extravascular RDN system in reducing BP, providing a promising alternative for patients with resistant hypertension or those ineligible for intravascular RDN. Further clinical trials are warranted to validate these results.