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In data from a global registry presented at the European Society of Cardiology (ESC) congress on Monday, Medtronic said its Symplicity renal denervation system continues to exhibit positive results in a real-world patient population. Michael Böhm, co-chair of the Global Symplicity Registry, remarked that "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 Symplicity HTN-2 trial.
Medtronic said the main goal of the registry is to confirm procedural safety of the Symplicity system, but it is also designed to collect efficacy data for in-office and ambulatory blood pressure measurement, as well as long-term cardiovascular outcomes from hypertension such as stroke, myocardial infarction, heart failure and cardiovascular death.
The device maker said that of the 1158 patients analysed in the registry, major complications or serious adverse events associated with the delivery of radio frequency energy to the renal artery were rare. Further, data showed that renal denervation with the Symplicity system resulted in significant and sustained blood pressure reductions at all time points up to 12 months in both in-office and ambulatory blood pressure measurement. Specifically, patients starting with systolic blood pressure of at least 180 mm Hg had an average in-office blood pressure reduction of -29 mm Hg to -17 mm Hg from baseline at six months, and -37 mm Hg to -23 mm Hg from baseline at 12 months.
Medtronic said the registry, which it described as the largest renal denervation registry in the world to date, will enroll more than 5000 patients with planned follow-up to five years. The registry will also gather data for other diseases characterised by elevated sympathetic drive, including type 2 diabetes, heart failure and chronic kidney disease.
The Symplicity system obtained the CE mark in 2008, but is only available for investigational use in the US. In March, Medtronic announced that the Symplicity system was included as part of a parallel review programme conducted jointly by the FDA and the US Centers for Medicare & Medicaid Services (CMS), which will allow the CMS to consider the system for national coverage while the FDA reviews the product's safety and efficacy.
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