Medtronic Receives FDA Approval for Altaviva, the First Implantable Tibial Neuromodulation Device for Urgency Urinary Incontinence

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• Implantation Method: Performed through a small incision at the ankle, the entire process is minimally invasive surgery, without the need for sedation or image guidance, and the operation is relatively simple.
  
• Device Size: Only about the length of half a stick of gum, it is implanted above the subcutaneous fascia and does not affect daily life.
  
• Mechanism of Action: By delivering electrical pulses to stimulate the tibial nerve, it helps restore neural signal transmission between the bladder and the brain, thereby improving bladder control.
• Usage Experience：

• Post-implantation therapy activates immediately, allowing patients to receive continuous treatment at home.
• The system operates automatically, without the need for daily patient intervention;
• Battery life can reach approximately15 Years；
• The charging process is simple, and it only requiresApprox. 30 minutesCan be completed.

• A total of 188 UUI patients were enrolled, serving as the core basis for FDA approval.
• Primary Endpoint: The number of acute urinary incontinence episodes decreased 6 months after implantation. ≥50%The proportion of patients (responder rate）。
• Secondary Endpoint: Improvement in daily urinary frequency, relief of urgency, and increase in OAB-qHRQL quality of life questionnaire scores.
• Safety: Reported 5 cases of device- or surgery-related adverse events, one of which was a severe wound infection requiring device removal 6 weeks after implantation.

• Enroll approximately 20 patients to validate the surgical procedure and preliminary efficacy.
• Immediate postoperative and follow-up visits both showed stimulation responses.14 DaysMost patients still maintained an effective response at the time.

The global urinary incontinence treatment devices market was approximately$31–38 billion, and is expected to reach 60–65 billion US dollars by 2032, with a compound annual growth rate of8%–11%Between. Among them, Sacral Nerve Stimulation (SNS), as the mainstream neuromodulation technology, had a global market size of approximately$1.6 billion, with a CAGR expected to exceed 11% before 2030, and even higher growth in the Asia-Pacific region (approximately 13%).

• Promise MedicalApproved for multiple implantable sacral nerve stimulation systems (stimulators, leads, electrodes, etc.) with independent intellectual property rights.
• ItsWearable Transcutaneous Tibial Nerve Stimulator (TTNS)Has also obtained the registration certificate for innovative medical devices, and is a representative product in the field of tibial nerve stimulation in China.
• Clinical cases in China show that the Department of Urology at Beijing Chaoyang Hospital has treated refractory urinary frequency, urgency, and incontinence using sacral nerve stimulation. Patients experienced a reduction in nighttime urination frequency, a decrease in daytime urination frequency, and an increase in urine volume, confirming the treatment's efficacy.