[2023. 11. 18.][NYSE:MDT]Medtronic announces FDA approval of minimally invasive device to treat hypertension

[2023. 11. 18.][NYSE:MDT]Medtronic announces FDA approval of minimally invasive device to treat hypertension

Medtronic plc (NYSE: MDT), a global healthcare technology leader, has just received FDA approval for its groundbreaking Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure. This marks a significant milestone in the world of hypertension treatment. With the green light from the FDA, Medtronic is gearing up for immediate commercialization.

Hypertension, commonly referred to as high blood pressure, is a pervasive health issue that can lead to heart attacks, strokes, and even death. It particularly affects underserved populations in the United States. Despite the availability of medications and lifestyle interventions, many struggle to control their blood pressure effectively. This approval is a promising development as it offers patients a new approach to managing hypertension.

Medtronic's Symplicity blood pressure procedure is an innovative, minimally invasive technique that employs radiofrequency energy to target nerves near the kidneys that can become overactive and contribute to high blood pressure. The procedure involves the insertion of a thin tube (catheter) into the artery leading to the kidney under sedation. Once in place, the medical team administers energy to calm the overactive nerves. The tube is then removed, leaving no implant behind.

"The Symplicity blood pressure procedure is a safe and effective method that significantly reduces blood pressure levels for patients," noted Dr. David Kandzari, Chief of the Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. "This milestone approval comes after extensive scientific research and clinical trials, including long-term studies with and without medication, and the largest real-world study."

Patient preference and shared decision-making are key elements in developing a comprehensive hypertension care plan that includes the Symplicity blood pressure procedure. A patient preference study conducted by Medtronic showed that when presented with an interventional treatment option with similar blood pressure reduction potential and associated risks as the Symplicity blood pressure procedure, approximately one third of patients were inclined to choose the interventional treatment.

Dr. Raymond Townsend, from the Hypertension Section at the University of Pennsylvania School of Medicine and co-principal investigator of the SPYRAL clinical program, emphasized, "This approval opens the door to a transformation in hypertension treatment, offering a complementary solution to medication and lifestyle changes. The Symplicity blood pressure procedure holds promise for both clinicians and patients, addressing an unmet need in hypertension care, especially for those seeking additional approaches to lower their blood pressure."

Medtronic's SPYRAL HTN Global Clinical Program is the most extensive clinical program dedicated to studying RDN, with over 25,000 patients treated globally. It encompasses studies conducted with and without medication, involving patients with high cardiovascular risk. While currently limited for investigational use in Japan, China, and Canada, the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries worldwide.

This approval represents a significant advancement in the field of hypertension treatment, providing patients with a promising adjunctive therapy option to better manage their blood pressure and reduce the risk of serious cardiovascular complications.

About Medtronic

Medtronic plc, headquartered in Dublin, Ireland, is a global healthcare technology company at the forefront of addressing some of the most challenging health issues worldwide. With a mission to alleviate pain, restore health, and extend life, Medtronic's diverse team of over 95,000 professionals across 150 countries develops innovative technologies and therapies that treat 70 different health conditions. Their portfolio includes cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more, all designed to make a positive impact on people's lives. Expect more from Medtronic as they continue to empower insight-driven care, prioritize patient experiences, and drive better outcomes for the world. For further information on Medtronic (NYSE:MDT), please visit www.Medtronic.com, and follow @Medtronic on Twitter and LinkedIn.