Medtronic Raises Fiscal 2027 Guidance as Revenue Jumps 13.7%

Medtronic announced that the American Medical Association has approved new Category I Current Procedural Terminology codes for two of its technologies, the Altaviva implantable tibial neuromodulation device for urge urinary incontinence and the Symplicity Spyral renal denervation system for uncontrolled hypertension. The new codes, which replace existing Category III codes, take effect in January 2028. Category I codes are permanent codes assigned to procedures the AMA deems well established, widely performed across the United States, and supported by robust clinical evidence, and while they can help support physician payment and inform commercial payer coverage decisions, they do not determine coverage, reimbursement, clinical superiority, or patient access. The Altaviva device was approved by the U.S. Food and Drug Administration in September 2025 for urge urinary incontinence, a condition affecting 16 million adults in the United States, and is placed under the skin near the ankle in a minimally invasive procedure. The Symplicity Spyral system was finalized for Medicare coverage in October 2025, and Medtronic said its SPYRAL HTN global clinical program is the most comprehensive studying renal denervation, with more than 5,000 patients and experience in over 40,000 patients globally.

Orchestra BioMed Holdings has surpassed full enrollment in the BACKBEAT Global Pivotal Trial of AVIM Therapy, with 330 patients randomized as of September 30, 2026, exceeding the previously announced target of 316. The trial is evaluating Atrioventricular Interval Modulation Therapy in pacemaker-indicated patients with uncontrolled hypertension despite medication, and is being conducted with Medtronic, the company's strategic collaborator for the trial and, subject to regulatory approval, for commercialization of AVIM Therapy. Enrollment reached 330 patients at 81 sites across 13 countries, while the FDA-approved protocol specifies 284 evaluable randomized subjects for the primary endpoint analysis, with the 316-patient target accounting for potential loss to follow-up. Orchestra BioMed reiterated prior guidance that primary endpoint data will be submitted for late-breaking presentation consideration at a major cardiovascular conference in the second quarter of 2027, and assuming positive results, Medtronic plans to submit AVIM Therapy marketing applications to the FDA and other global regulatory agencies promptly. The trial's primary efficacy endpoint is the between-group difference in the change in 24-hour ambulatory systolic blood pressure at three-month follow-up from pre-randomization baseline, and the protocol-specified sample size provides greater than 90% statistical power to detect a between-group difference of at least 5 mmHg.