Medtronic PLC (NYSE:MDT) has announced its plans to initiate the SPYRAL HTN Global Clinical Trial Program; the program will study the renal denervation in uncontrolled hypertension. The comment comes following investigational device exemption (IDE) by the USFDA. The study will be started, with two global studies on clinical potential of the therapy and confounding effects in the SYMPLICITY HTN-3.
Jason Weidman, VP and General Manager of Medtronic Coronary and Renal Denervation state that there is an unmet need for better medication for people, with uncontrolled hypertension. The research department wants to explore the clinical potential of renal denervation, he added.
Weidman stated that they had done extensive analysis and additional clinical trials following the SYMPLICITY HTN-3 trial. He also added that consultation from FDA has been sought, and Medtronic is in partnership, with various other research organizations to develop a breakthrough clinical trial protocol.
The SPYRAL HTN Global Clinical Trial Program will collect randomized trials overseen by experts to investigate the impact of renal denervation, both in the presence and absence of anti hypersensitive medications.
The study will have approximately 100 patients with low-high risk of hypertension. The trials will be of SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED, a third SYMPLIYCITY HTN-e trial will be done on sever and treatment-resistant patients.
The SPYRAL- OFF MED study discerns the effects of renal denervation on blood pressure reduction. This has been recommended both the USFDA and the global clinical community
The SPYRAL-ON MED study is to study the effects of renal denervation on blood pressure in the presence of antihypertensive medication.
SYMPLICITY HTN-3 trial is to figure out the effects on the most severe patients with high blood pressure.
According to Dr. Townsend, studying both on and off medication patients will help bring clarity to the true nature of the therapy.