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Implantable tibial neuromodulation

Altaviva™ system

<p>The Altaviva™&nbsp;implantable tibial neuromodulation system is approved for urge urinary incontinence (UUI).</p>

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Features

How the Altaviva™ system works

  1. The Altaviva™ device can be placed using the Medtronic Pocket Dissector† above the fascia near the ankle
  2. With no sedation or imaging required1, device is placed with a small, 2 cm incision1 along the Langer lines​
  3. The system automatically delivers therapy stimulation on a schedule to the tibial nerve, helping reduce UUI symptoms.3

† Surgical instrument is recommended for use, but not required. Sold separately.​

In addition to risks related to surgery, complications can include pain at the implant site, infection, reaction to local anesthesia, wound complications, lower leg pain, nerve injury, movement of the implant, adverse change in bowel or urinary function, uncomfortable or unintended stimulation sensations, loss of therapeutic effect, discomfort during recharge, or technical or device problems. Please refer to Important Safety Information for more details.

Why choose the Altaviva™ system?

Designed to deliver a streamlined experience for you and your patients from day one.

Streamlined procedure​

  • Single1, minimally invasive procedure2,​ completed at various sites of service​​
  • No sedation or imaging required1​ for implantation of device​​
  • Optimized healing​ with 2 cm incision1 along Langer line
Altaviva™ system with programmer and pocket dissector

Streamlined patient experience​

  • Same-day therapy activation9​ for fewer follow-ups​
  • Automatic therapy delivery ​with customized settings9
  • MRI ready from the start9 1.5T and 3T ​full-body labeling‡​
  • Long-lasting device​ with expected 15 years of therapy§,9​

Ordering information

Device and kits

Item number Description
P7850N​ Altaviva™ neurostimulator for use with the Altaviva™ patient kit
P7K2P001​ Altaviva™ system patient kit. Accessory kit for programming and recharging the neurostimulator. Includes patient carry case, Altaviva(tm) patient programmer with therapy application software, programmer charging cord and adaptor, wireless recharger communicator, wireless recharger communicator dock, dock charging cord and adaptor, ankle band, ankle band adjusters
P7K2C001 Altaviva™ system clinician kit. Accessory kit for programming and recharging the device. Includes carry case, wireless recharger communicator and dock, dock charging cord and adaptor, ankle band, and ankle band adjusters
CT900F Altaviva™ system clinical programming tablet
P71001 Medtronic pocket dissector (recommended)

 

Related links

† Surgical instrument is recommended for use, but not required. Sold separately.​

‡ Under certain conditions; see approved labeling for details​.

§ Based on clinical and bench testing for expected therapy settings.

In addition to risks related to surgery, complications can include pain at the implant site, infection, reaction to local anesthesia, wound complications, lower leg pain, nerve injury, movement of the implant, adverse change in bowel or urinary function, uncomfortable or unintended stimulation sensations, loss of therapeutic effect, discomfort during recharge, or technical or device problems. Please refer to Indications, Safety, and Warnings for more details.​

  1. M028930C001RevB - Altaviva™ Model P7850N Neurostimulator Implant manual
  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. Appendix B: Clinical Study Summary. M028929C001 RevC - Clinician Therapy and Programming Guide Altaviva™ Model P7850N.
  4. Peters KM, Carrico DJ, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010;183:1438-1443. 
  5. Peters KM, MacDiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. 2009;182(3):1055-1061. 
  6. Kobashi K, Nitti V, Margolis E, et al. A prospective study to evaluate efficacy using the NURO percutaneous tibial neuromodulation system in drug-naïve patients with overactive bladder syndrome. J Urol. 2019;131:77-82. 
  7. Rogers A, Bragg S, Ferrante K, et al. Pivotal study of leadless tibial nerve stimulation with eCoin for urgency urinary incontinence: an open-label, single arm trial. J Urol. 2021;206:399-408. 
  8. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. A prospective study to assess the effectiveness and safety of the BlueWind system in the treatment of patients diagnosed with urgency urinary incontinence. Neurourol Urodyn. 2024;43:1491-1503. 

  1. M028929C001 RevC - Clinician Therapy and Programming Guide Altaviva™ Model P7850N