The REDUCE-HTN Post-Market Study (PMS), including the First in Man (FIM) cohort, is a prospective, non-randomized, single arm, multicenter study evaluating the Vessix™ Renal Denervation System in patients with resistant hypertension. Enrolled patients had office-based systolic blood pressure (SBP) ≥ 160 mm Hg while on ≥ 3 antihypertensive medications (including a diuretic unless the patient had a documented intolerance to diuretics) at maximally tolerated doses.
A total of 146 patients were enrolled and treated at 23 centers in Europe, Australia, and New Zealand.
No patients experienced prespecified acute safety events
Procedure-related serious adverse events* of 5.5% among the 146 patients to date Hematoma, bilateral flank pain, vomiting, pseudoaneurysm at access site, thrombus at access site, access site infection (2), renal artery stenosis requiring treatment†
6-month patency§ 99.2% (252/254 arteries**) by core lab duplex ultrasound analysis.