Medtronic Scores FDA Nod for Next-Gen InterStim

Medtronic continues to up its game in sacral neuromodulation.

FDA approved InterStim X, the next generation of the company's InterStim portfolio's recharge-free device. Medtronic said implants have begun and are underway with the first implant in the nation performed by Ryan Krlin, MD, associate professor of urology at Louisiana State University Health Sciences Center New Orleans.

Both the new recharge-free InterStim X device, or the rechargeable InterStim Micro device are used in the treatment of overactive bladder, chronic fecal incontinence, and non-obstructive urinary retention.

"Countless people suffer from symptoms of bladder and bowel control conditions and thanks to significant recent technology advancements, SNM therapy is becoming a more popular option for patients," said Jannah H. Thompson, MD, president of the Society of Women in Urology, and a urologist at Urologic Consultants in Grand Rapids, Michigan. "This is not your grandmother's therapy. It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief."

Medtronic said the InterStim X device is designed with proprietary fifth-generation battery chemistry that offers more than 10 years of battery life without the need to recharge, providing patients with more freedom and less maintenance. With low energy settings, the device may last up to 15 years. The InterStim Micro features proprietary Overdrive battery technology that offers more than 15 years of battery life with regular recharging once a month, and the smallest rechargeable SNM device on the market. Both systems feature a programming device that allows patients to independently adjust their choice of 11 settings at home or on-the-go, and SureScan technology that allows patients to undergo full body 1.5T and 3T MRI scans.

"We're on a mission to expand access to proven nerve stimulation therapies through technology advancements like InterStim X, InterStim Micro, SureScan MRI technology and the smart programmer, by offering patients personalized therapy options and by reaching them through direct-to-consumer marketing," said Mira Sahney, president of the pelvic health business at Medtronic."As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation."