Medtronic (NYSE: MDT) announced today that it received FDA approval for its Altaviva neuromodulation device.
Altaviva, a minimally invasive implantable tibial neuromodulation (ITNM) device, is inserted near the ankle and designed to treat urge urinary incontinence (UUI).
Patients who receive an Altaviva device return home with therapy activated. Medtronic says this marks a first among implantable tibial devices for treating UUI. The insertion process takes place in a minimally invasive procedure requiring no sedation or imaging, according to Medtronic — one of the largest medtech companies in the world.
(MDO’s Medtech Big 100 Special Report takes a deep look at the world’s 100 largest medical device companies, including Medtronic. Visit here for a free download.)
Altaviva comes in at approximately half the length of a stick of chewing gum, according to a news release. It sits slightly below the skin and above the fascia to send electrical impulses to the tibial nerve. This process helps restore communication between the bladder and the brain to regulate bladder control.
The device has a 15-year battery lifespan under expected therapy settings and delivers therapy automatically. It requires no daily intervention or manual adjustments from the patient. Recharging takes up to 30 minutes when using the default speed, eliminating the need for daily at-home charging equipment.
“The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” said Dr. Kevin Benson, urogynecologist at Sanford Health and investigator for the Altaviva device pivotal study (TITAN 2). “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
Commentary from Medtronic officials
Emily Elswick, president of the Pelvic Health business at Medtronic, said:
“It’s an honor to bring the Altaviva device to market. For too long, society has told people it is normal to eventually lose bladder control. We say, ‘Enough.’ What is common does not mean it is normal. The Altaviva device is designed to provide a simple and effective experience to treat urge urinary incontinence, empowering patients with a technology that supports them in their daily lives and opens the door to renewed hope and improved quality of life.”
Brett Wall, EVP and president of the Medtronic Neuroscience portfolio, added:
“Too many people silently struggle with the challenges of urgency and loss of bladder control, often believing that relying on diapers or pads is their only option. The Altaviva device represents a transformative milestone and ushers in a new bladder control therapy with advanced features. Medtronic has earned its position as the global leader in neuromodulation by consistently pushing the boundaries of innovation, and this FDA approval underscores our unwavering commitment to delivering therapies that truly change lives.”
