Target BP

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension

The first line of treatment for high blood pressure (hypertension) is lifestyle changes, including eating  a  healthier  diet,  quitting  smoking,  getting  more  exercise,  and  losing  weight  when overweight  or  obese. If  such  lifestyle  modifications  do  not  control  the  high  blood  pressure, several  types  of  medications,  collectively  referred  to  as antihypertensive  medications,  are available for   treating hypertension,   which   may   be   used   alone   or   in   combination.   The effectiveness of antihypertensive  medications to  lower  blood pressure  is  well  established,  and control  of  blood  pressure  can be  achieved  in  most patients by  careful  selection  of  appropriate drugs  and  doses.  However,  adverse  effects  of  antihypertensive  drugs  are  common,  and  may lead  to   persons   not   taking   their   medication   correctly   or   stopping all  together.  

Ablative Solutions, Inc., has manufactured a new drug/device combination product called the Peregrine System™ Kit (also referred to as the Peregrine Kit). The Peregrine Kit contains a device, the Peregrine System™ Infusion Catheter (also referred  to  as  the  Peregrine  Catheter),  and  a  drug dehydrated alcohol for injection (also referred to as alcohol).  The Peregrine Kit is designed to deliver small amounts of nerve-destroying medicine (alcohol) through the study catheter to the space around the kidney blood vessels (renal arteries). Destroying nerve fibers that run along the kidney blood vessels interrupts nerve signals that may cause high blood pressure. This is called renal denervation. Subjects whose high blood pressure cannot be improved by medicine and lifestyle changes may be able to use renal denervation to reduce their high blood pressure, when used along with their current blood pressure medication. It is important to understand that this procedure is not to replace your blood pressure medications, but to be done only when taking them.  

Please contact our Clinical Trials Office for information: (352) 273-8933 ufcardiovascularct@medicine.ufl.edu