The licensing covers the management of essential hypertension in patients for whomblood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated.
Approval in Canada comes about four months after the company’s landmark FDA approval for Symplicity Spyral in November 2023.
Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure. These nerves can become overactive and contribute to high blood pressure.
After sedation, a doctor inserts a catheter that can treat a range of vessel sizes into the artery leading to the kidney. The doctor then administers energy to calm the excessive activity of the nerves connected to the kidney. Then, the doctor removes the catheter, leaving no implant behind.
Symplicity Spyral holds approval for commercial use in more than 70 countries around the world
“As the pioneer in renal denervation, we are looking forward to making a difference for hypertension patients in Canada,” said Maisie Cheung, director of marketing, Medtronic 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.”
Read more about Medtronic’s pursuit of approval for its RDN system at Medical Design & Outsourcing.
