Press Release: On April 1, 2015, Medtronic announced the initiation of the SPYRAL HTN Global Clinical Trial Program, a unique, phased clinical program studying renal denervation in uncontrolled hypertension. 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.
Over the past year, Medtronic has analyzed the renal denervation clinical trials, conducted new pre-clinical research, and consulted with thought-leaders, regulatory and reimbursement bodies. The result of this effort is an evidence strategy that aims to achieve worldwide approval and acceptance of renal denervation for uncontrolled hypertension.
The unique, phased SPYRAL HTN Global Clinical Trial Program will include two new global, prospective, randomized, sham controlled trials with patients both off- and on-antihypertensive medication regimens with Medtronic’s next-generation Symplicity Spyral™ catheter and Symplicity G3™ generator. Note, the Symplicity Spyral catheter and Symplicity G3 generator are not approved for marketing in the U.S. or Japan.
The SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies will each examine approximately 100 patients at 20 centers globally with moderate-to high-risk hypertension, as opposed to the severe, treatment resistant population studied in the SYMPLICITY HTN-3 trial.
This approach, designed to address the confounding factors encountered in the SYMPLICITY HTN-3 trial, will help to simultaneously demonstrate the impact of renal denervation on blood pressure both in the absence and presence of antihypertensive medication. Medtronic’s goal is to demonstrate a clear efficacy signal and understand the impact of drugs on the renal denervation effect. Based on the outcomes of these two initial studies of the SPYRAL HTN Global Clinical Trial Program, Medtronic will evaluate next steps for a pivotal study to support a pre-market application (PMA) submission to the FDA and Shonin submission in Japan.