Your browser is out of date
With an updated browser, you will have a better Medtronic website experience. Update my browser now.
The Symplicity Spyral™ renal denervation system is indicated to reduce blood pressure as an adjunctive treatment in patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
The Symplicity Spyral system is contraindicated in patients with any of the following conditions:
A thorough understanding of the technical principles, clinical applications, and risks associated with vascular access techniques and percutaneous transluminal catheterization in renal arteries is necessary before using this device.
The safety and efficacy of the Symplicity Spyral system has not been established in patients with isolated systolic hypertension or in patients with prior renal artery interventions including renal stents, renal angioplasty, or prior renal denervation. The Symplicity Spyral system has not yet been studied in patients who are breastfeeding, under the age of 18, or with secondary hypertension.
Potential adverse events associated with use of the renal denervation device or the interventional procedures include, but are not limited to, the following conditions:
Please reference appropriate product Instructions for Use and User Manual for more information regarding indications, contraindications, warnings, precautions, and potential adverse events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
For further information, please call and/or consult Medtronic at 800-633-8766 or the Medtronic website at medtronic.com.
Tell us what you’re interested in so we can send relevant information, education, and resources directly to your inbox.