Medtronic receives FDA approval for urinary incontinence device

GALWAY, Ireland - Medtronic plc (NYSE:MDT), a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $122.6 billion, announced today it has received U.S. Food and Drug Administration approval for its Altaviva device, a minimally invasive implantable tibial neuromodulation therapy designed to treat urge urinary incontinence. According to InvestingPro data, the company maintains a robust gross profit margin of 65.4%, reflecting its strong market position in medical technology.

The device, approximately half the length of a stick of chewing gum, is implanted near the ankle during a procedure that requires no sedation or imaging. It sends electrical impulses to the tibial nerve to help restore communication between the bladder and brain for improved bladder control.

According to the company’s press release, bladder control problems affect an estimated 43 million U.S. adults, with nearly 16 million suffering from urge urinary incontinence, a common symptom of overactive bladder characterized by sudden, intense urges to urinate often followed by involuntary leaks.

The Altaviva device features a 15-year battery lifespan under expected therapy settings and delivers treatment automatically without daily patient intervention. It requires recharging for up to 30 minutes when using default settings and is MRI-compatible.

"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.

With this approval, Medtronic becomes the only company offering a complete portfolio of neuromodulation therapies for bladder control conditions, according to the company statement.

Medtronic will host an investor call to discuss the device and its impact on the treatment landscape for urge urinary incontinence on October 9, 2025. The company, currently trading near its 52-week high, maintains a "GOOD" financial health score according to InvestingPro’s analysis. Investors can access detailed financial metrics, 10+ ProTips, and comprehensive research reports through InvestingPro’s premium service.

In other recent news, Medtronic announced that its Hugo robotic-assisted surgery system met primary safety and effectiveness endpoints in a hernia repair study. This study, involving 193 patients, achieved a 100% surgical success rate, surpassing the pre-specified performance goal of 85%. Additionally, TD Cowen reiterated its Buy rating on Medtronic, maintaining a $106 price target, citing potential Medicare coverage for the company’s renal denervation therapy. Meanwhile, Piper Sandler maintained a Neutral rating on Medtronic, highlighting ongoing challenges in the company’s surgical business due to market shifts toward robotic procedures and GLP-1 medications.

Orchestra BioMed Holdings presented long-term data on its atrioventricular interval modulation therapy, showing sustained blood pressure reduction over an average of 3.6 years in patients. The therapy demonstrated an average reduction of 8.9 mmHg in 24-hour ambulatory systolic blood pressure. In other developments, Piper Sandler reiterated its Overweight rating on DexCom with a $100 price target, emphasizing strong growth in the continuous glucose monitoring market, driven primarily by basal insulin users. These updates reflect the latest developments impacting these companies in the medical technology sector.

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