Global healthcare technology company Medtronic has received the US Food and Drug Administration (FDA) approval for its InterStim X, and is commercialising the device.
InterStim X is the new-generation of recharge-free device in the company’s InterStim portfolio.
InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy.
Medtronic claimed that the SNM system is backed by more than 90 clinical studies, 1,000 clinical articles, has treated 350,000 patients for 25 years.
The recharge-free InterStim X device, or its rechargeable version InterStim Micro device are used to treat overactive bladder (OAB), chronic faecal incontinence (FI), and non-obstructive urinary retention.
Urologic Consultants urologist Jannah H Thompson said: “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.
“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.”
The InterStim X device leverages the company’s unique 5th generation battery chemistry that offers more than 10 years of battery life, eliminating the need to recharge.
When used with low energy settings, the device may last up to 15 years, and provides patients with more freedom and less maintenance, said Medtronic.
The InterStim Micro device uses unique overdrive battery technology that offers more than 15 years of battery life with regular recharging once a month
It is the smallest, most powerful rechargeable SNM device available, according to the company.
Both the systems come with a programming device, in the size of a normal smartphone, that enables patients to adjust their choice of therapy using 11 different settings.
Also, the devices leverage SureScan technology to facilitate full body 1.5T and 3T MRI scans under certain conditions, which eliminates the need for impedance checks.
Medtronic pelvic health business president Mira Sahney said: “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.
“As we celebrate 25 years of InterStim this year, we’re bullish about our next chapter in patient-focused therapy innovation.”
