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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Medtronic 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.