Health Canada has issued a licence for Medtronic’s Symplicity Spyral multi-electrode renal denervation (RDN) system for the management of hypertension.
The system is designed for patients whose blood pressure remains high despite medication and lifestyle changes or when guideline-driven therapy is not tolerated well.
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Said to be a minimally invasive technique, the Symplicity Spyral system targets overactive renal nerves, a key contributor to hypertension, utilising radiofrequency ablation.
The approval from Health Canada is based on clinical data, highlighting the system as one of the most extensively evaluated cardiovascular interventional devices.
Clinical trials have demonstrated that the procedure can significantly reduce office systolic blood pressure by over 9mmHg within three to six months and by more than 18mmHg at three years. These reductions have been sustained in a cohort of over 1,500 patients.
Furthermore, the procedure has been shown to reduce blood pressure independent of medications, with very low rates of adverse events, ensuring patient safety.
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By GlobalDataMedtronic said the procedure has demonstrated safe and durable blood pressure reductions in patients with uncontrolled hypertension.
Medtronic Canada marketing director Maisie Cheung said: “As the pioneer in renal denervation, we are looking forward to making a difference for hypertension patients in Canada.
“This means more choices for patients — and offers physicians an adjunctive option along with lifestyle changes and medications to help manage patients with high blood pressure.”
The Symplicity Spyral system is now approved for use commercially in more than 70 countries.
Last year, Medtronic secured the Food and Drug Administration approval for the Symplicity Spyral RDN system.
