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Medtronic's Announcement on National Coverage Analysis for Symplicity™ Spyral System

In a landmark development, Medtronic plc (NYSE: MDT), a prominent name in healthcare technology, has announced that the Centers for Medicare & Medicaid Services (CMS) is embarking on a national coverage analysis (NCA) for renal denervation. This comes as good news for patients grappling with hypertension, as the analysis aims to shape a national Medicare coverage policy for renal denervation procedures, which includes Medtronic's Symplicity™ Spyral renal denervation system.

Jason Weidman, Senior Vice President of Medtronic's Coronary and Renal Denervation business, emphasized the urgency of addressing hypertension, labeling it as a global health epidemic. With hypertension affecting a significant section of the population, the need for innovative treatment options is critical. He expressed appreciation for CMS's commitment to accelerating access to such pioneering technologies.

The push for a national coverage analysis has been fueled by Medtronic's ongoing collaboration with CMS, particularly through the Transitional Coverage for Emerging Technologies (TCET) pathway, designed to facilitate coverage for breakthrough devices. The renal denervation system, having gained U.S. FDA approval recently, is anticipated to have its national coverage analysis complete by October 11, 2025. Until then, procedures utilizing the Symplicity blood pressure approach will be reviewed on a case-by-case basis, dependent on the medical necessity for individual Medicare beneficiaries.

Understanding the Symplicity Spyral System

The Symplicity Spyral RDN system is a cutting-edge, minimally invasive procedure that employs radiofrequency energy to address overactive nerves located near the kidneys, which contribute to high blood pressure. Notably, it stands out as the sole commercially available renal denervation device backed by an extensive array of long-term, robust data. The evidence, drawn from the SPYRAL-HTN clinical trials, showcases an average office blood pressure reduction of 18 mmHg over a three-year period across diverse real-world settings.

This clinical program is significant, with over 4,000 patients studied under varying conditions—both with and without medications. Participants showed sustained drops in blood pressure, demonstrating the efficacy of the Symplicity Spyral system and its potential to impact patient health outcomes positively.

Hypertension: A Major Public Health Concern

Hypertension remains a pressing public health issue, affecting over 1 billion adults globally. It is recognized as a leading modifiable risk factor for heart attacks, strokes, and premature death. Alarmingly, nearly 80% of individuals diagnosed with hypertension struggle to keep their blood pressure under control, often becoming non-adherent to medication within the first year of treatment. This underscores the importance of exploring new therapeutic options like the Symplicity renal denervation.

Medtronic's commitment to alleviating health challenges resonates strongly within its corporate mission. As a global leader in healthcare technology, Medtronic aims to tackle some of the most daunting health issues through innovation and transformative solutions. With over 95,000 dedicated employees and operations in more than 150 countries, the company continually strives to enhance patient care through its diverse range of technologies, which address up to 70 different health conditions, including major cardiac and surgical products.

For further details on Medtronic and its initiatives, visit Medtronic's website.

The announcement marks a significant stride in ensuring wider access to life-changing medical technologies for those suffering from hypertension, a step that aligns well with Medtronic's vision of empowering patient-centered care and improved health outcomes across the globe.