Medtronic Receives Category I CPT® Code Approvals for Altaviva and Symplicity Spyral Systems

Coding approvals reflect growing clinical evidence and physician adoption of Medtronic solutions addressing urge urinary incontinence and hypertension 

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the American Medical Association (AMA) approved new Category I Current Procedural Terminology (CPT®) codes for two of its technologies, which represent important long-term growth opportunities for Medtronic: Altaviva™ implantable tibial neuromodulation device for the treatment of urge urinary incontinence and Symplicity Spyral™ renal denervation (RDN) system for the treatment of uncontrolled hypertension. The new codes, which will replace existing Category III codes, are effective January 2028.

Category I CPT® codes are permanent codes assigned to procedures the AMA has determined are well established, widely performed by physicians across the United States (U.S.), and supported by robust clinical evidence, in addition to other criteria identified in the application process. While a Category I CPT® code establishes a permanent code and can help support physician payment and inform commercial payer coverage decisions, it does not determine coverage, reimbursement, clinical superiority, or patient access.

"These Category I approvals reflect the robust clinical evidence and physician adoption for innovative solutions addressing critical gaps in care and unmet patient needs," said Lindsay Bockstedt, vice president of health economics, policy, and reimbursement at Medtronic. "The decision by AMA represents meaningful progress in the reimbursement pathway for these technologies, as Medtronic remains committed to reducing barriers to broader adoption and patient access. We're grateful to the stakeholders and clinical community whose work made this possible."

The AMA approved new Category I CPT® codes applicable to procedures associated with the following Medtronic technologies:

Altaviva™ Implantable Tibial Neuromodulation Device
The Altaviva™ device was approved by the U.S. Food and Drug Administration (FDA) in September 2025, for the treatment of urge urinary incontinence (UUI) – a condition that impacts 16 million adults in the U.S. ¹ The Altaviva™ device is indicated for treatment of UUI in patients who failed or could not tolerate more conservative treatments. The device is approximately half the length of a stick of chewing gum and is placed under the skin near the ankle in a minimally invasive procedure.² The device delivers stimulation to the tibial nerve to help restore communication between the bladder and brain to improve bladder leakage symptoms. ^3-4 Unlike some other treatment options, the Altaviva™ device does not require imaging for implantation and only needs local anesthesia, and it can be activated the same day as the procedure. The system is designed to provide patients with a simple, long-lasting treatment experience, including an expected 15 years of therapy under expected therapy settings. The Altaviva™ device is also MRI-compatible from the start⁵, offering patients peace of mind for future medical imaging needs.

Symplicity Spyral™ Renal Denervation System
The Symplicity Spyral renal denervation (RDN) system, finalized for Medicare coverage in October 2025, is an innovative, 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. The Medtronic SPYRAL HTN global clinical program is the most comprehensive clinical program studying RDN in more than 5,000 patients in the presence and absence of medication, and with high baseline cardiovascular risk, and is backed by experience in over 40,000 patients globally.^6-13 

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.

CPT® codes, descriptions and other data only are copyright 2025 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

1. Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014
2. Cameron AP, Chung DE, Dielubanza EJ et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder (2024). J Urol. 2024;212:11-20.  
3. Li X, Li X, Liao L. Mechanism of action of tibial nerve stimulation in the treatment of lower urinary tract dysfunction. Neuromod. 2023;27:256-266.
4. Bhide AA, Tailor V, Fernando R, Vik K, Digesu GA. Posterior tibial nerve stimulation for overactive bladder - techniques and efficacy. Int Urogynecol J. 2020;31:865–70.
5. M028929C001 RevC - Clinician Therapy and Programming Guide Altaviva™ Model P7850N
6. Medtronic data on file, RDN Catheter Historical Data, Feb 2025. Data includes both Symplicity Flex and Symplicity Spyral.
7. Kandzari DE, Townsend RR, Kario K, et al. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823.
8. Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. 
9. Kario K, Ogawa H, Okumura K, et al. SYMPLICITY HTN-Japan - first randomized controlled trial of catheter-based renal denervation in asian patients -. Circ J. 2015;79(6):1222–1229.
10. Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial renal denervation for resistant hypertension. N Engl J Med. April 10, 2014;370(15):1393–1401.
11. Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFFMED): a randomised, sham-controlled, proof-of-concept trial. Lancet. November 11, 2017;390(10108):2160–2170.
12. Krum H, Schlaich MP, Sobotka PA, et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. 2014;383(9917):622–629.
13. Medtronic data on file, RDN Catheter Historical Data, September 2026. Data includes both Symplicity Flex and Symplicity Spyral.

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