Medtronic has said it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation system using a targeted procedural approach with a reduced number of radio frequency ablations. Set to enrol 50 patients at up to 15 sites in the USA and Europe, the single-arm study is designed to focus on ablating the distal main renal artery and primary branches to lower blood pressure using a simplified procedural approach.

In addition to the SPYRAL DYSTAL study, the Medtronic SPYRAL HTN global clinical programme includes the SPYRAL HTN-OFF MED Pivotal and SPYRAL HTN-ON MED trials, both prospectively powered, randomised, sham-controlled studies evaluating patients with uncontrolled blood pressure in the absence and presence of prescribed anti-hypertensive medications, respectively. The programme also includes the real-world GLOBAL SYMPLICITY registry that has enrolled more than 2,700 patients with the Medtronic Symplicity system, including 600 patients with the Symplicity Spyral catheter.

Andrew Sharp University Hospital of Wales, Cardiff, UK), co-principal investigator of the SPYRAL DYSTAL study, says: “In-depth anatomical study indicates the renal nerves are closer to the renal artery in the distal renal artery and branches. Focusing the procedure on these targeted locations may help us understand if we can achieve meaningful blood pressure reductions more efficiently. Early evidence using this modified approach has been encouraging and we intend to build on that data with the DYSTAL study.”

Furthermore, results from the SPYRAL HTN OFF MED pivotal trial will be presented as a late-breaking clinical trial at the American College of Cardiology (ACC) 69th Annual Scientific Sessions (28–30 March, Chicago, USA). The prospective, international, randomised, sham-controlled study is investigating the blood pressure lowering effect and safety of renal denervation with the Symplicity Spyral system in the absence of medication.

Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, states: “As we strive to build upon the rigorous renal denervation studies within the SPYRAL HTN clinical programme, the DYSTAL study will help inform how we can fine-tune the procedure and continue to address the unmet need in hypertension management. Medtronic is committed to realising the full potential of renal denervation, and we look forward to the highly anticipated results of the SPYRAL HTN-OFF MED pivotal trial to be unveiled at ACC in March.”