Medtronic, a medical technology company, has announced CE Mark approval in Europe and Therapeutic Goods Administration (TGA) listing in Australia for its Symplicity Spyral catheter and Symplicity G3 radio frequency (RF) generator.
Medtronic has designed the new system to reduce the ablation time and provide ease of deliverability during renal denervation procedures for patients with uncontrolled hypertension.
The highly flexible 4 Fr multi-electrode Symplicity Spyral catheter incorporates the company's proprietary Symplicity treatment algorithm and Symplicity helical ablation pattern responsible for the clinical success and safety profile of the single-electrode Symplicity renal denervation system.
Symplicity Spyral catheter has four electrodes that deliver RF energy simultaneously or selectively into the renal artery wall for disrupting the output of overactive sympathetic nerves. The catheter has a non-occlusive design which ensures the non obstruction of renal blood flow during the procedure.
The catheter is compatible with a 6 Fr guide catheter and is highly conformable to artery shape and size, encompassing vessel diameters of 3-8mm.
Powered by a new RF generator, the Symplicity Spyral catheter is delivered over a 0.014 inch guide wire through a rapid exchange system.
The G3 generator uses the benefits of Medtronic's proprietary Symplicity treatment algorithm with its built-in safety features. It has a new touch screen user interface that is compatible with the single-electrode Symplicity catheter.
Medtronic Renal Denervation general manager and vice president Nina Goodheart noted as the company continues to drive the future of renal denervation as a treatment for uncontrolled hypertension, it is excited to deliver its fast and efficient multi-electrode Symplicity Spyral system, inspired by years of clinical experience and collaboration with top thought leaders in the field.
"We have significantly enhanced our technology with sophisticated features designed to meet specific unmet needs and we believe these improvements, coupled with our strong safety and efficacy profile, will provide unprecedented benefit to both patients and physicians," Goodheart added.
The Symplicity renal denervation system is available for investigational use only in the US.
