FDA approves Medtronic’s next-generation InterStim X system
Medtronic (NYSE: MDT) today announced that the FDA has approved its next-generation InterStim X refill-free device.
The medical technology giant has made the latest sacral neuromodulation (SNM) therapeutic product from the InterStim portfolio immediately available. Both the InterStim X No Refill and the InterStim Micro Refill are used to treat overactive bladder (OAB), chronic faecal incontinence (FI), and non-obstructive urinary retention.
InterStim X features proprietary fifth-generation battery chemistry designed to deliver over 10 years of battery life without the need to recharge, increasing freedom and reducing maintenance for the patient. Medtronic said in a press release that with low power consumption settings, the device can last up to 15 years.
Medtronic added that InterStim X, together with InterStim Micro, includes the first and only Smart Programmer, a programming device that resembles a common smartphone and allows patients to discreetly and independently adjust their choice of 11 therapy parameters at the home or on the go.
Additionally, the platforms include SureScan technology which enables 1.5T and 3T full body MRI scans under certain conditions without the need for impedance checks.
“We are on a mission to expand access to proven nerve stimulation therapies through technology advancements such as InterStim X, InterStim Micro, SureScan MRI technology and the Smart Programmer, providing patients with personalized therapy options and by reaching them through direct-to-consumer marketing.”, President of Medtronic for Pelvic Health Mira Sahney said in the statement. “As we celebrate 25 years of InterStim this year, we are optimistic about our next chapter in patient-centered therapy innovation.”