BlueWind Medical, based in Park City, Utah, has achieved a significant milestone with the FDA's recent approval of its Revi neuromodulation system through a de novo marketing request. This innovative medical device promises new hope for millions of individuals suffering from urinary urgency incontinence (UUI).
Revi is a tibial neuromodulation system designed to address the challenges posed by UUI. This condition, characterized by sudden and uncontrollable urges to urinate, can significantly impact a person's quality of life. BlueWind's Revi offers a novel approach to managing UUI.
The cornerstone of Revi's approval was the successful completion of the OASIS pivotal trial. This study included 151 women and aimed to evaluate the device's safety and efficacy in treating UUI. The results were nothing short of remarkable.
At the six-month mark, participants in the OASIS trial experienced statistically significant improvements in urge incontinence incidents. Impressively, 76.4% of those with Revi implants saw a 50% reduction in episodes. Even more promising, after 12 months, 82% of participants had achieved the same level of symptom improvement.
Perhaps the most compelling statistic is that, at the one-year mark, nearly 50% of participants (69 out of 139) reported being 100% dry for three consecutive days. This is a remarkable achievement, demonstrating the potential for Revi to offer lasting relief to those suffering from UUI.
One of the key advantages of Revi is its minimally invasive implantation procedure, which can be performed on an outpatient basis. The device, a small, battery-free gadget, is placed near the ankle to stimulate the posterior tibial nerve. To activate it, users simply wear a lightweight, wireless ankle wearable, making it a user-friendly and convenient solution.
The innovative battery-free design of Revi, measuring only 3 cm long and 3 mm wide, not only enhances user convenience but also minimizes the risk of battery depletion, lead fracture, and lead migration surgery. This represents a significant step forward in the field of neuromodulation devices.
BlueWind's CEO, Dan Lemaitre, expressed his pride in achieving FDA approval, emphasizing the company's dedication to providing a groundbreaking solution for individuals living with UUI. He noted that this approval marks the beginning of an exciting chapter for BlueWind Medical, reaffirming their commitment to helping patients regain control over their UUI symptoms.
Dr. Cindy L. Amundsen, a distinguished expert in the field of urogynecology, highlighted the impact of UUI on patients' lives and underscored the significance of Revi as a potential new option. She suggested that this outpatient procedure could be considered earlier in a patient's treatment journey, potentially providing relief before more conservative therapies fail.
