First Patient in the RESTORE Clinical Study of Revi™ System for Urge Urinary Incontinence Treated in Tampa, Florida
28 Feb 2024
Drug Approval
Participants now being recruited for RESTORE study to expand the evidence base for Revi, a minimally invasive, FDA-authorized, patient-centric tibial neuromodulation therapy
PARK CITY, Utah, Feb. 28, 2024 /PRNewswire/ -- BlueWind Medical, Ltd. today announced that Dr. Osvaldo Padron of Florida Urology Partners in Tampa, Florida, has treated the first patient in the RESTORE study, a prospective, multi-center, open label, post market, randomized controlled trial. The RESTORE study will recruit 150 patients at up to 20 centers in the United States.
Revi is an innovative implantable Tibial NeuroModulation (iTNM) device that offers safe and effective treatment for UUI, as demonstrated in the OASIS pivotal study. Revi is placed near the ankle in a single predictable procedure under local anesthesia and is powered by a lightweight external wearable that is used at the patient's convenience once or twice daily to provide therapy. When activated, the Revi Implant stimulates the posterior tibial nerve to provide relief from UUI. Revi received FDA marketing authorization in August 2023, with no conditions of approval or post market study requirements. Revi is the only neuromodulation therapy on the market that allows physicians
to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating "step-therapy."
"Urge urinary incontinence is disruptive, embarrassing, and causes undue stress in people's lives. Current treatments work for some people, but not most. There has been a real need for a more patient-centric and minimally invasive treatment option for people," said Dr. Padron. "I am pleased to have treated the first patient with the Revi System as part of the RESTORE study, an important clinical study that will help advance treatment options for people who suffer from urge urinary incontinence. Our site is recruiting additional qualifying study participants, and I encourage people to apply."
"This is a great day in our collective journey to bring more convenient, comfortable, and patient-centric treatment options to people suffering from the debilitating symptoms of urge urinary incontinence," said Dan Lemaitre, Chief Executive Officer of BlueWind Medical. "We are so grateful to Dr. Padron for treating the first patient in this critical research effort to help transform the treatment paradigm for UUI."
About the RESTORE study:
RESTORE is a post market randomized control trial to compare the efficacy of the Revi™ System Therapy On versus Off in Reducing Urinary Urge Incontinence Episodes. BlueWind Medical elected to initiate this trial to build on the body of evidence supporting the efficacy of the Revi System in reducing urge urinary incontinence (UUI) symptoms. The study is currently recruiting participants. To determine if you may qualify, please visit BlueWind Medical's study webpage. You can also find more details about the RESTORE study (NCT06217328) on clinicaltrials.gov.
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 implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA marketing authorization for patients with UUI.
For additional information about BlueWind Medical, please visit www.bluewindmedical.com.
SOURCE BlueWind Medical
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