Medtronic has reported preliminary information 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 system.
The main objective of the Global SYMPLICITY Registry is to confirm procedural safety with the Symplicity system.
There were no major complications or serious adverse events related to delivery of radio frequency (RF) energy to the renal artery other than one procedural dissection (0.09%) and one re-intervention at six months (0.09%) in 1,158 patients analysed in the registry with available follow-up information.
The Symplicity system showed significant and sustained blood-pressure reductions after renal denervation in both in-office and ambulatory blood-pressure measurement at all time points up to one year compared with baseline.
The study data was presented by Global SYMPLICITY Registry co-chair Dr Michael Böhm at the European Society of Cardiology congress.
"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 randomised, controlled clinical trial, Symplicity HTN-2," Dr Böhm said.
The Global SYMPLICITY Registry, reportedly the largest renal denervation registry in the world, will enrol a minimum of 5,000 patients who undergo the renal denervation procedure, from more than 200 sites worldwide with planned follow-up to five years.
"We are pleased that enrollment and analysis of the registry continues to meet our goal of establishing procedural safety and efficacy of the Symplicity system, which we expect will ultimately help reduce the risk of cardiovascular events associated with treatment-resistant hypertension such as stroke and ischemic heart disease," Dr Böhm said.
The registry also will also document the data for other diseases characterised by elevated sympathetic drive, such as diabetes mellitus type 2, heart failure and chronic kidney disease.
The Symplicity renal denervation system consists of a proprietary generator and flexible catheter, which delivers a controlled, low-power radio-frequency (RF) energy through a proprietary algorithm, or pattern, aiming to deactivate the surrounding renal nerves.
The Symplicity system received CE mark approval in 2008 and is currently available for investigational use only in the US.
Medtronic anticipates that its global Symplicity clinical programme will involve more than 8,000 patients including the US, Europe, and Japan, with more than 1,200 of these patients participating in randomised clinical trials.
Image: Symplicity Renal Denervation System. Photo: courtesy of Medtronic Inc.
