First Patients Treated in Hypertension Clinical Study Using Renal Denervation System


February 29, 2012

February 29, 2012 — Vessix Vascular Inc. announced initial patient treatments in the international multicenter Reduce-HTN renal denervation clinical study for uncontrolled hypertension.

Reduce-HTN is a nonrandomized, prospective, single cohort, 64-patient clinical study designed to validate the clinical performance of the Vessix V2 Renal Denervation System for medication-resistant hypertensive patients. Renal denervation is a new percutaneous catheter-based procedure that disrupts renal sympathetic nerves whose hyperactivity leads to abnormally high blood pressure. The renal denervation procedures employing the Vessix balloon catheter were performed at Paracelsus Medical University in Salzburg, Austria, by interventional cardiologist Uta Hoppe.

The first patient treated was 39 years old with pre-treatment blood pressure readings of 174/114, despite taking four anti-hypertensive medications. The second patient was 44 years old with a blood pressure of 168/106, despite taking six anti-hypertensive medications.

"We found the catheter easy to use and quite efficient in terms of therapy time. Moreover, the patient required modest amounts of intravenous anxiolytics and narcotics since the therapy was delivered in a matter of seconds," said Hoppe following the procedure.

By design, all patients enrolled in the study have a baseline systolic blood pressure greater than 160 mm Hg despite being treated by at least three anti-hypertensive drugs. The 10-center Reduce-HTN study will enroll patients at medical centers in Austria, Belgium, Germany, Switzerland, France, Netherlands and Australia. The study, which calls for patients to be followed for 24 months, will capture post-treatment office-based and ambulatory blood pressure measurements at various time points in accordance with internationally recognized guidelines. In addition to assessing the patient's clinical condition, the renal arteries of treated patients will be imaged at various time points post-treatment to confirm safety of the procedure.

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