Ardian, Inc. (Ardian), a provider of minimally invasive treatment of hypertension, is planning to complete the phase I clinical trial entitled “Renal Denervation in Patients With Refractory Hypertension” for Symplicity Catheter System by December 2009. The objective of the study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension. The trial is currently recruiting participants in US.
This is a non-randomized, open label, single group assignment trial with an estimated patient enrollment of 20. The Principal Investigator of the study is Bradley Bart, MD from Hennepin County Medical Center.
Symplicity Catheter System is a tube like device that delivers energy to the nerves surrounding the renal arteries. It is intended to decrease conduction through these nerves in a way that triggers the body’s own regulation mechanisms to lower blood pressure. It is used for the patients whose blood pressure cannot be controlled with medication alone.