The transition to Category I status signifies that the Altaviva implantable tibial neuromodulation device for urge urinary incontinence and the Symplicity Spyral renal denervation system for uncontrolled hypertension have met rigorous standards for clinical efficacy. While these permanent codes do not automatically mandate coverage or dictate specific reimbursement rates, they provide a standardized framework that simplifies the billing process for physicians and informs commercial payer policies.
Lindsay Bockstedt, vice president of health economics at Medtronic, noted that the approvals reflect the company's progress in addressing significant gaps in patient care. The Altaviva device, an ankle-implanted solution for overactive bladder, and the Symplicity Spyral catheter system, designed to reduce blood pressure by calming overactive kidney nerves, now move into a more mature phase of market integration. The move follows years of clinical trials, including the extensive SPYRAL HTN global program, which has tracked renal denervation outcomes across 5,000 patients.

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