Regulatory Bluewind Medical Gets FDA De Novo Clearance For Neuromod...

Bluewind Medical Gets FDA De Novo Clearance For Neuromod System

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After learning about a novel method for treating overactive bladder, the FDA has given it de novo clearance in the U.S. This comes a few years after the treatment received CE mark clearance in Europe.

BlueWind Medical, the company that created the neurostimulation technology, announced the regulatory victory. Unlike traditional neuromodulation methods, which target the sacral nerve in the lower back, BlueWind’s technique combines an implanted microdevice with an outwardly worn ankle band that stimulates the tibial nerve, which is responsible for controlling bladder function.

This system, formerly known as the Renova iStim, now goes by the name ‘Revi’. The FDA approved it to treat adults with urge urinary incontinence (UUI), a condition characterized by an urgent and uncontrollable need to urinate.       

According to BlueWind Medical CEO Dan Lemaitre, the de novo clearance is a major achievement that demonstrates the company’s dedication to creating a novel solution for the millions of people who suffer from this condition.

He added, “As we embark on this exciting new chapter, we remain dedicated to our mission of improving the lives of the patients we serve by helping them regain control of their UUI symptoms.”

The three-centimeter large, battery-free Revi implant is inserted just under the skin, close to the ankle, during a minimally invasive procedure that requires solely local anesthesia. Users engage the gadget through 30-minute sessions once or twice daily by strapping a wireless wearable device, which contains the system’s power source, over their ankle.

The device stimulates the posterior tibial nerve during treatment sessions in an effort to prevent incontinence-related neural impulses from reaching the brain. Meanwhile, the Revi Hub’s wireless connectivity allows it to gather data on each therapy setting and send it on to the Clinician Programmer application, where clinicians can view and make adjustments to their patients’ programs.

The myRevi app is available to patients independently and provides them with information on UUI, a symptom tracker to record their progress throughout neurostim treatment, and access to technical help for the Revi system.

BlueWind claims that the approval came after the FDA reviewed data from the Oasis study, which implanted the technology in 151 women with UUI. After six months, over three quarters of all implanted individuals saw a reduction in urge incontinence incidents of at least 50%. For the 139 women who finished the year-long study, this percentage rose to 82.

Participants who stayed in the trial for a whole year used the Revi system on a consistent basis, with adherence to the once-daily treatment schedule being nearly 92% of the time.

According to BlueWind, no major negative occurrences were reported, and all procedure- or device-related adverse effects were graded as mild or moderate.

To speed up the commercialization of the neuromod system in the U.S. after receiving FDA approval, BlueWind completed a $64 million fundraising round in May 2022. ConvaTec, a competitor in the incontinence device market, spearheaded the series B funding round.

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