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.
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