Park City, UT—BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI), is excited to announce that Revi is now available in Shreveport, Louisiana at Christus Surgery Center with world-renowned urologist Dr. Gerard Henry.
“As a physician, I am always looking for new therapies that address the unmet needs of my patients. Urge incontinence is a condition that affects millions of people in the U.S. with debilitating effects, and yet most struggle to find a satisfactory solution," noted Dr. Gerard Henry. “Revi is a unique device that allows patients to control their own therapy and adjust it to their individual needs. It is also a minimally invasive outpatient procedure that does not require general anesthesia, which makes it more convenient and comfortable for many patients. I am delighted to share that I am now offering this groundbreaking treatment to patients who suffer from urge incontinence."
Revi is the only battery-free iTNM implant on the market and features a miniature implant along with innovative wearable technology to power the device. Revi is implanted near the ankle during a single outpatient procedure performed under local anesthesia, and without the potential adverse events seen with other surgical UUI therapies. When activated, the Revi implant stimulates the posterior tibial nerve to provide relief from UUI. For activation, a lightweight wireless wearable is placed around the ankle once or twice daily to provide stimulation at the patient’s convenience.
BlueWind has achieved several milestones with Revi recently that demonstrate its commitment to innovation in patient care. The US Food and Drug Administration (FDA) granted a De Novo marketing request on August 16, 2023, for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. In October, the American Medical Association (AMA) CPT Editorial Panel announced the final Current Procedural Terminology (CPT) code to describe the subfascial tibial neuromodulation implant procedure, 0817T. In November, the Centers for Medicare & Medicare Services (CMS) finalized the facility payment (unadjusted national average of USD $20,854 related to hospital outpatient services) for subfascial procedures for tibial neuromodulation that pertain to the Revi device.
“We are delighted that this novel technology is now available in Shreveport with Dr. Henry. Revi has the potential to revolutionize the treatment landscape for UUI by giving patients more control, comfort, and convenience. We are honored to bring this life-changing technology to the millions of people who suffer from UUI and help them regain their confidence and dignity," said Dan Lemaitre, Chief Executive Officer of BlueWind Medical.
About BlueWind Medical Ltd.
BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall wellbeing of patients with an initial focus on those living with urgency urinary incontinence (UUI). BlueWind’s Revi System is the first and only battery-free implantable tibial neuromodulation device to receive FDA marketing authorization for patients with UUI.For additional information about BlueWind Medical, please visit www.bluewindmedical.com
SOURCE BlueWind Medical