CMS grants Transitional Pass-Through Payment for Medtronic Symplicity Spyral renal denervation catheter

The Symplicity blood pressure procedure offers patients a new adjunct approach to lowering blood pressure

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for the Medtronic Symplicity Spyral ™ renal denervation (RDN) catheter, used in the Symplicity ™ blood pressure procedure, under the Medicare Hospital Outpatient Prospective Payment System. TPT payment, which will be effective for up to three years beginning January 1, 2025 aims to support patient access to new and innovative technology, including devices granted Breakthrough Device Designations like the Symplicity Spyral RDN system.

"Receiving TPT approval for our RDN catheter is an important milestone for the Symplicity blood pressure procedure, as it will enable greater patient access to a breakthrough treatment by reducing cost barriers for healthcare systems," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "Very few technologies achieve this qualification, and the core goals of fostering innovation and increasing access mirror Medtronic's desire to continue bringing Symplicity to even more patients suffering from uncontrolled high blood pressure. We look forward to continuing to work with CMS to establish coverage and expand patient access."

Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke, and death, 1 and its prevalence is notably worse in underserved U.S. populations. 2 Despite available medications and lifestyle interventions, control rates remain low. The prevalence of hypertension underscores the importance for availability of adjunctive treatment options that patients may benefit from to better manage their blood pressure.

The purpose of the TPT program is to support access to newly approved innovative technologies where the costs to adopt them may otherwise inhibit patient access. The TPT program reduces barriers for Medicare beneficiaries to access critical healthcare innovations shortly after products receive FDA approval by providing hospitals with additional payments to cover their costs, while allowing CMS to collect necessary cost data to determine future outpatient payments.

Approved by the U.S. Food and Drug Administration (FDA) in November 2023 , the Medtronic Symplicity Spyral RDN System is a minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.

Supporting TPT approval is the Medtronic SPYRAL HTN Global Clinical Program, which is the most comprehensive clinical program studying RDN in the presence and absence of medication, and in patients with both high and lower baseline cardiovascular risk. The Symplicity Spyral RDN System is approved for commercial use in more than 75 countries around the world and is backed by experience in more than 25,000 patients treated globally with the Symplicity blood pressure procedure. The Symplicity Spyral renal denervation system is limited for investigational use in Japan .

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1 Bundy JD, Mills KT, Chen J, et al. Estimating the Association of the 2017 and 2014 Hypertension Guidelines With Cardiovascular Events and Deaths in US Adults: An Analysis of National Data. JAMA Cardiol. 2018 Jul 1 ;3(7):572-581.
2 Aggarwal R, et al. Hypertension. 2021;78(6):1719-1726.

Contacts:

Krystin Hayward Leong

Ryan Weispfenning

Public Relations

Investor Relations

+1-508-261-6512

+1-763-505-4626

(PRNewsfoto/Medtronic plc)

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SOURCE Medtronic plc

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SOURCE ATCO Ltd.

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A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera Mapping and Ablation System and Sphere-9 Catheter

  • First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter
  • Highly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve
  • Now with two pulsed field ablation (PFA) offerings and a portfolio of electrophysiology solutions, Medtronic is shaping the future of arrythmia treatment today

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced United States Food and Drug Administration (FDA) approval of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, an all-in-one, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AFib) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.

Affera™ Mapping and Ablation System

With this approval, Medtronic is now the first and only company with two PFA technologies available for patients with Afib. The PulseSelect™ Pulsed Field Ablation System, which was FDA approved in December 2023 , offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) while the Affera Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath.

"The significance of this innovative technology should be underscored; Affera is a game changer for treatment of Afib and atrial flutter," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. "The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of Afib."

With a trailblazing design, the Sphere-9 catheter offers physicians the option of both PF and RF energy delivery, fully integrated with the Affera Mapping and Ablation System. The Sphere-9 catheter enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.

"The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. By enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy," said Doron Harlev , vice president of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera. "This marks an exciting milestone for the field, with Medtronic's robust innovation pipeline poised to drive continued progress."

The approval was based on excellent results demonstrated in the pivotal SPHERE Per-AF study , an FDA Investigational Device Exemption (IDE) trial, which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the conventional Thermocool SmartTouch® SF radiofrequency ablation catheter with the Carto™*3 System. The Affera Mapping and Ablation System and Sphere-9 catheter also received CE Mark in March 2023 and was approved in Australia in September 2024 . In October 2024 , Medtronic announced the start of an early feasibility study to evaluate the Sphere-9 catheter for treatment of ventricular tachycardia (VT), a cardiac arrhythmia in which the lower chamber of the heart beats abnormally fast.

"At Medtronic, we have a 75-year tradition of bringing disruptive innovation to market, guided by our mission and commitment to address the unmet needs of patients. With the approval of Affera, we are excited to bring a novel mapping and ablation solution to clinicians that is intended to make atrial fibrillation treatment safer, more effective, and more efficient," said Rebecca Seidel , president of the Cardiac Ablation Solutions business, which is part of the Medtronic Cardiovascular Portfolio. "The potential of Affera is limitless. We will continue to fulfill our commitment to innovation, including new indications, to advance cardiovascular care and improve patient outcomes."

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxsymal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on Affera and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic  
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.
*Thermocool SmartTouch and Carto are trademarks of Biosense Webster, Inc.

Contacts:


Leslie Williamson

Ryan Weispfenning

Public Relations

Investor Relations

+1-612-227-5099

+1-763-505-4626

Sphere-9™ Catheter

(PRNewsfoto/Medtronic plc)

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SOURCE Medtronic plc

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