4 results
The purpose of this clinical investigation is to verify the efficacy and safety of the CVRx Neo System in subjects who qualify for the implantation for a Baroreflex Activation Therapy System compared with subjects who do not receive this device.
The primary objective of this study is to compare Arm 1 with Arm 2 with regard to incidence of new onset diabetes Mellitus as per the American Diabetic Association criteria at any point up to 24 weeks after kidney transplantation.The secondary…
Primary objective: to compare the effect two immunosupressive therapy regimens on GFR estimated by iohexol clearance at week 52 post kidney transplantationSecundary objective: to compare the safety and efficacy profiles of the two immunosupressive…
Safety and performance will be based on a comparison of overall success rates of the Barricaid ARDand either a concurrent group (nonrandomized) of control patients treated by conventional surgicalmethods (e.g., noninstrumented discectomy) at select…