February 4, 2020
Medtronic Begins SPYRAL DYSTAL Pilot Study of Renal Denervation in Hypertensive Patients
February 4, 2020—Medtronic announced it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation (RDN) system using a targeted procedural approach with a reduced number of radiofrequency (RF) ablations. The Symplicity Spyral system is limited to investigational use in the United States, Japan, and Canada. The device is approved for commercial use in more than 50 countries.
According to the company, the single-arm study will enroll 50 patients at up to 15 sites in the United States and Europe. It will focus on ablating the distal main renal artery and primary branches to lower blood pressure using a simplified procedural approach.
Andrew Sharp, MD, Coprincipal Investigator of the SPYRAL DYSTAL study, commented in the company's press release, “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.” Dr. Sharp is an interventional cardiologist at the University Hospital of Wales, in Cardiff, United Kingdom.
Medtronic advised that results from the SPYRAL HTN-OFF MED Pivotal Trial will be presented as a Late-Breaking Clinical Trial at the American College of Cardiology 69th Annual Scientific Sessions on March 29, 2020, in Chicago, Illinois. The prospective, international, randomized, 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.
In addition to the SPYRAL DYSTAL study, the Medtronic SPYRAL HTN Global Clinical Program includes the SPYRAL HTN-OFF MED Pivotal and SPYRAL HTN-ON MED trials, both prospectively powered, randomized, sham-controlled studies evaluating patients with uncontrolled blood pressure in the absence and presence of prescribed antihypertensive medications, respectively. The program also includes the real-world Global SYMPLICITY Registry that has enrolled > 2,700 patients with the Medtronic Symplicity RDN system, including 600 patients with the Symplicity Spyral catheter.