Medtronic has unveiled new data from the Global SYMPLICITY Registry, a multi-centre, prospective, observational registry designed to collect comprehensive data evaluating procedural and long-term safety of the Symplicity renal denervation system at the ESC (European Society of Cardiology) congress.
The analyzed data from 1,158 patients in the registry with follow-up information available showed rare major complications or serious adverse events related delivery of radio frequency energy to the renal artery, including one procedural dissection (0.09%) and one re-intervention at six months (0.09%).
When compared to baseline, renal denervation with the Symplicity system showed significant and sustained blood pressure reductions at all time points up to 12 months in both in-office and ambulatory blood pressure measurement.
University of Saarland, Homburg/Saar, Germany chairman and Global SYMPLICITY Registry co-chairman Dr Michael Bohm noted it is encouraging that preliminary data with this sizeable patient cohort in a real-world setting continue to demonstrate a strong safety profile and significant clinical efficacy for renal denervation with the Symplicity system, similar to what we’ve been seeing in the randomized, controlled clinical trial, Symplicity HTN-2.
"We expect will ultimately help reduce the risk of cardiovascular events associated with treatment-resistant hypertension such as stroke and ischemic heart disease," Dr Bohm added.
The Symplicity system features a flexible catheter and proprietary generator, which are used to perform a renal denervation procedure, a minimally invasive, catheter-based procedure that modulates the output of nerves that line the walls of the arteries leading to the kidneys.