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Study Design

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.

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Office Blood Pressure Reduction Office Blood Pressure Reduction

    

24-hours Ambulatory Blood Pressure Reduction 24-hours Ambulatory Blood Pressure Reduction

 

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.