Medtronic Statement on the 2024 European Society of Cardiology Guidelines for Hypertension and Renal Denervation

Medtronic is encouraged by the new the European Society of Cardiology (ESC) 2024 guidelines, which upgraded renal denervation (RDN) as a class IIb recommendation, providing a safe and effective complementary care option for patients with uncontrolled and resistant hypertension. The new guidelines were presented at the European Society of Cardiology (ESC) Congress on August 30, 2024, in London, United Kingdom.

The new ESC guidelines are the second set from Europe, following the ESH guidelines and consensus statements from leading countries, underscoring the role of the Medtronic Symplicity Spyral™ Renal Denervation System (also known as the Symplicity blood pressure procedure) for hypertension care.

Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke and death.¹ Despite available medications and lifestyle interventions, control rates remain low. In fact, hypertension affects about 1.28 billion adults worldwide and about 80% don't have their blood pressure under control.¹ These challenges speak to the possibility that patients may benefit from a complementary care option, to better manage their blood pressure.

"Uncontrolled hypertension has a devastating impact around the world, which makes us further emboldened to provide innovative solutions like the Symplicity blood pressure procedure to patients who could potentially benefit," said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "These updated guidelines are also important for physicians as they reinforce RDN as an additional hypertension care option for those patients who may not respond adequately to lifestyle changes and medication management."

The new ESC guidelines outline patient selection criteria that includes adult patients with uncontrolled and resistant hypertension. Emphasis was placed on those patients with high cardiovascular risk, who remain uncontrolled and who express a preference to undergo RDN in a tailored, shared decision-making process.

The ESC guidelines have been made possible largely by the amount of clinical evidence that has been generated with the Medtronic Symplicity blood pressure procedure. The Medtronic RDN clinical program is backed by experience in over 25,000 patients treated globally. It has also been studied in over 4,000 patients in the presence and absence of medication, and in patients with high baseline cardiovascular risk, or with comorbidities.

Medtronic looks forward to advancing the field of RDN through our continued clinical programs with the SPYRAL AFFIRM and GSR-DEFINE studies, as well as external research programs, and through planned advances in technology.

Currently limited for investigational use in Japan, the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 75 countries around the world.

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¹ WHO. Hypertension fact sheet. September 13, 2019. Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension. Accessed February 15, 2022.