Medtronic has welcomed the publication of the consensus statement on renal denervation issued by the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).
The statement, published in the European Heart Journal and EuroIntervention last week, concludes that renal denervation represents another treatment option in patients with uncontrolled resistant hypertension and may be used in selected patients deemed intolerant to antihypertensive drugs.
In its statement, Medtronic notes that this is the latest in a series of position papers and consensus statements from key societies, including the European Society of Hypertension (ESH), the Society for Cardiovascular Angiography and Interventions (SCAI), and the National Kidney Foundation, in support of renal denervation as a safe and effective adjunctive treatment option in reducing blood pressure for uncontrolled hypertensive patients.
In reviewing evidence to produce the statement, the writing committee drew on long-term data from multiple studies, including data from the Medtronic SPYRAL HTN clinical programme, which studied the company’s Symplicity Spyral multi-electrode radiofrequency renal denervation device.
“In summary, this latest consensus statement not only supports the safety and effectiveness of renal denervation as a third pillar for uncontrolled (resistant) hypertension—along with lifestyle changes and medication—but it also suggests how physicians can implement and utilise this treatment option in their clinical practice where renal denervation products are commercially approved,” Medtronic’s statement reads. “This is a positive step forward and reflects the importance of new treatment options within the clinical community to help improve hypertension control rates.”
Medtronic recently announced it has submitted the Symplicity Spyral premarket approval (PMA) package to the US Food and Drug Administration (FDA) for review. Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral renal denervation system is currently limited to investigational use in the USA, Japan and Canada.
