Medtronic’s Symplicity Spyral RDN System Receives Health Canada License

March 19, 2024—Medtronic announced it received a license from Health Canada for its Symplicity Spyral multielectrode renal denervation (RDN) system. The device is indicated for the management of essential hypertension in patients for whom blood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated.

According to Medtronic, approximately one in four Canadian adults are affected by hypertension, and it’s estimated that 90% of individuals will develop high blood pressure at some point during their lifetime. The minimally invasive Symplicity blood pressure procedure uses radiofrequency ablation to calm the nerves near the kidneys that can become overactive and contribute to high blood pressure.

“As we look to improve options to help manage patients with hypertension, we’re encouraged by this latest approval of the Symplicity Spyral renal denervation system,” commented Sheldon Tobe, MD, in Medtronic’s press release.

Dr. Tobe, who is a nephrologist and hypertension specialist at Sunnybrook Health Sciences Centre in Toronto, Canada, continued, “There is a big unmet need in Canada for the subset of patients who can’t fully control hypertension with medication and/or lifestyle changes. This innovative procedure will help to fill that gap by potentially helping to improve blood pressure control.”

Medtronic advised that the Health Canada license is based on clinical evidence backing the Symplicity RDN procedure that demonstrated the following:

• Office systolic blood pressure reduced by > 9 mm Hg at 3 to 6 months and > 18 mm Hg at 3 years with sustained blood pressure reductions at 3 years in more than 1,500 patients.
• Significant, safe, and durable blood pressure reductions in uncontrolled hypertension patients, independent of medications.
• Very low rates of adverse events, making for a safe procedure.
• Improved blood pressure control with significantly more time in treatment range after radiofrequency RDN when compared to sham through 3 years.

The company further noted that data have shown that small blood pressure reductions significantly reduce cardiovascular risk—a 5-mm Hg reduction leads to a 5% lower risk of cardiovascular death, 8% lower risk of coronary artery disease, 10% lower risk of major cardiovascular events, 13% lower risk of stroke, and 13% lower risk of heart failure.

Mina Madan, MD, who is an interventional cardiologist at Schulich Heart Program Sunnybrook Health Sciences Centre, stated in the press release, “The Symplicity blood pressure procedure opens the door to manage high blood pressure in the long term through a safe and effective procedure. It’s really exciting to think about how this adjunctive therapy can help manage hypertension for many more people who’ve struggled to get their blood pressure under control in the past.”