Medtronic to commence new programme for renal denervation in uncontrolled hypertension with Symplicity Spyral HTN device.

Medtronic has announced the initiation of the Spyral HTN Global Clinical Trial Program, a unique, phased clinical program studying renal denervation in uncontrolled hypertension. This announcement follows investigational device exemption (IDE) approval by the FDA.The program will begin with two global studies designed to address the confounding factors encountered in the SYMPLICITY HTN-3 clinical trial, including medication, patient population and procedural variability, to ensure the clinical potential of the therapy is evaluated.

Physicians in both studies will perform renal denervation with Medtronic's next-generation renal denervation technology, composed of the highly flexible 6 Fr compatible, multi-electrode Symplicity Spyral catheter and Symplicity G3 radiofrequency (RF) generator. The Symplicity Spyral catheter and G3 generator are investigational in the United States and Japan. The Spyral HTN Global Clinical Trial Program includes two global, prospective, randomized, sham-controlled trials conducted simultaneously by experienced proceduralists to investigate the impact of renal denervation both in the absence of and in the presence of antihypertensive medications. The SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies will each include approximately 100 patients with moderate- to high-risk hypertension, as opposed to the severe, treatment resistant population studied in the SYMPLICITY HTN-3 trial.

Comment: Renal denervation is essentially severance of nerves near the kidney to reduce uncontrolled or resistant hypertension.The development of such devices by Medtronic, St Jude and Boston Scientific received a set back when the Symplicity device failed to reduce hypertension in the SYMPLICITY HTN-3 trial.The launch by Medtronic of two major trials reflects continued faith in renal denervation as a way to reduce blood pressure without the side effects of medication or the pill burden that affects compliance. Boston Scientific also plans a new trial for its Vessix system for completion in 2016.