Trade Resources Industry Views Preliminary Data From Global Symplicity Registry Is Unveiled by Medtronic

Preliminary Data From Global Symplicity Registry Is Unveiled by Medtronic

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.

 

Source: http://www.medicaldevices-business-review.com/news/medtronic-unveils-preliminary-data-from-global-symplicity-registry-030913
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Medtronic Unveils Preliminary Data From Global Symplicity Registry