AMA Approves Category I CPT Codes for Two Medtronic Device Procedures

Medtronic plc (MDT ) announced on October 1, 2026, that the American Medical Association approved new Category I Current Procedural Terminology (CPT) codes for procedures associated with two of its technologies: the Altaviva implantable tibial neuromodulation device, used to treat urge urinary incontinence, and the Symplicity Spyral renal denervation system, used to treat uncontrolled hypertension. The new codes will replace existing Category III codes and are effective January 2028, the company said. Medtronic characterized the two technologies as important long-term growth opportunities.

AMA Panel Record

The AMA’s own record of the decision, its September 2026 CPT Editorial Summary of Panel Actions, documents the specific code actions. Under Tab 19, Renal Nerve Denervation, the CPT Editorial Panel accepted the addition of codes 37X47 and 37X48 to report transcatheter renal sympathetic denervation, added guidelines in a Renal Nerve Denervation subsection, and deleted Category III codes 0338T and 0339T, effective January 2028. Tabs 33 and 34 were voted as a single panel action. Under Tab 34, Integrated Tibial Neurostimulator Services, the panel accepted codes 64X21, 64X22, 64X23, and 64X24 for reporting open implantation or replacement of an integrated neurostimulation system, and/or revision or removal of such a system; revised guidelines in the Neurostimulators subsection; and deleted codes 0816T, 0817T, 0988T, 0818T, 0819T, and 0989T, also effective January 2028.

The AMA states that codes containing an X are placeholder codes intended, through their first three digits, to indicate a proposed placement in the code set. They are not used for claims reporting, and codes are not assigned, nor exact wording finalized, until just prior to publication of the CPT code set. The AMA prepares a summary document after each CPT Editorial Panel meeting covering actions taken on each code application. Requests for reconsideration of the September 2026 panel actions must be received by AMA staff no later than midnight Central time on October 16, 2026.

According to Medtronic’s announcement, 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, and supported by robust clinical evidence, in addition to other criteria identified in the application process. The company stated that a Category I code establishes a permanent code and can help support physician payment and inform commercial payer coverage decisions, but that 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.”

The Two Systems

The Altaviva device received U.S. Food and Drug Administration approval on September 19, 2025, per an earlier Medtronic announcement. It is indicated for treatment of urge urinary incontinence in patients who failed or could not tolerate more conservative treatments. Bladder control problems affect an estimated 43 million U.S. adults, or one in six, according to the company, and nearly 16 million of them have urge urinary incontinence, a common symptom of overactive bladder. Medtronic has stated that only a quarter of people with general bladder control issues have discussed their symptoms with a doctor.

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 that requires only local anesthesia and no imaging, the company states. It delivers stimulation to the tibial nerve to help restore communication between the bladder and brain, can be activated the same day as the procedure, and is MRI-compatible. Medtronic states the system is designed to provide an expected 15 years of therapy under expected therapy settings, with recharging taking up to 30 minutes at the default speed. The device’s pivotal study was known as TITAN 2, and the company states that with the Altaviva introduction it became the only company offering a full portfolio of neuromodulation therapies for bladder control symptoms.

The Symplicity Spyral renal denervation system delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. After sedation, a physician inserts a single thin tube, known as a catheter, into the artery leading to the kidney and administers energy to calm the excessive nerve activity; the catheter is then removed, leaving no implant behind, according to Medtronic.

On October 28, 2025, the Centers for Medicare and Medicaid Services issued a National Coverage Determination covering FDA-approved renal denervation for uncontrolled hypertension under Coverage with Evidence Development when furnished in accordance with the criteria specified in the determination, according to CMS. CMS lists the Medtronic-sponsored SPYRAL CARE study, ClinicalTrials.gov number NCT07174622 with a CMS approval date of October 30, 2025, as meeting the requirements for coverage under Coverage with Evidence Development. The study evaluates real-world clinical outcomes in Medicare patients with hypertension treated with Symplicity renal denervation plus standard of care versus standard of care alone, using integrated electronic health record and claims data. Medtronic describes its SPYRAL HTN global clinical program as the most comprehensive clinical program studying renal denervation, with more than 5,000 patients studied in the presence and absence of medication and with high baseline cardiovascular risk, backed by experience in over 40,000 patients globally.