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.
Boston Scientific collaborates with researchers, physicians and hospital systems worldwide to advance the science of cardiovascular medicine. A key component of that commitment is the Vessix Global Clinical Program, which includes both the REDUCE-HTN and RELIEVE Clinical Series. The REDUCE-HTN Clinical Series plans to enroll more than 1,200 resistant hypertension patients worldwide and already includes the largest cohort of patients studied following treatment with a multi-electrode renal denervation system. The RELIEVE Clinical Series includes pre-clinical, clinical and investigator initiated research evaluating the Vessix System technology in additional disease states including end-stage renal disease, heart failure, atrial fibrillation and diabetes.
REDUCE – HTN Interim 6 Month Data
Presenter: Horst Sievert MD
WebcastCurrent Learnings with Felix Mahfoud
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Caution: Investigational device limited under U.S. law for investigational use only. Not for sale in the U.S.
* Serious adverse events (SAEs) defined according to International Organization for Standardization ISO14155.
† Baseline stenosis was 17% based on core lab assessment of angiogram; stenosis of 60% noted by angiography at 6 month follow-up; patient received percutaneous transluminal angioplasty/stent and continues to be monitored.
§ Patency defined as stenosis < 60%.
** Treated renal arteries with 6 month post-treatment diagnostic DUS.
Schofer J, MD. REDUCE-HTN Clinical Study interim 12- and 18-month Data. Presented at EuroPCR; May 2014.