The world’s largest medical device company, run out of Fridley, Minn., announced Feb. 4 that it has started enrollment in a pilot study that will use the company’s Symplicity Spyral renal denervation in a targeted procedural approach, with fewer radio frequency (RF) ablations.
The single-arm study will enroll 50 patients at up to 15 sites in the U.S. and Europe. It will focus on ablating the distal main renal artery and primary branches to lower blood pressure utilizing a simplified procedural approach.
“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,” said Dr. Andrew Sharp, an interventional cardiologist at the University Hospital of Wales, in Cardiff, U.K., and co-principal investigator of the Sypyral Dystal study.
“Early evidence using this modified approach has been encouraging, and we intend to build on that data with the Dystal study,” Sharp said in a news release.
Dave Moeller, VP and GM of Medtronic’s Coronary and Renal Denervation business, said the study would help fine-tune the procedure.
Approved for commercial use in more than 50 countries, the Symplicity Spyral system is only an investigational device in the United States, Japan, and Canada.
Once considered the next big thing for the medical device industry, renal denervation’s reputation took a hit in the middle of the 2010s when Medtronic announced a major clinical trial had failed to meet its efficacy endpoint. The company, though, has since sought to clear up some of the confounding factors – namely, issues around differing medication regimens and patient compliance — that may have played a role in the Symplicity HTN-3 study’s failure.