FDA Clearance for StaySure Device by Minnesota Medical Technologies
Minnesota Medical Technologies has exciting news—it has received FDA 510(k) clearance for its innovative fecal incontinence device, StaySure. This marks a significant advancement in the management of fecal incontinence and accidental bowel leakage, conditions that affect millions.
What is the StaySure Device?
StaySure is a disposable, user-friendly, self-inserted fecal incontinence insert designed to improve the lives of those suffering from these challenges. This groundbreaking product is made from 100% silicone and contains a unique encased fluid that allows it to adapt to individual body movements throughout the day. With its soft silicone design and flexible structure, StaySure ensures a secure yet comfortable fit.
Expert Insights from Leadership
David A. Jonas, the CEO of Minnesota Medical Technologies, expressed his excitement regarding the FDA's approval, stating, "We are thrilled to have received U.S. regulatory clearance for StaySure, and I want to congratulate our product development and regulatory teams for their excellent work in achieving this important milestone for the company." Jonas emphasizes the significance of StaySure in offering a practical and effective solution for those enduring fecal incontinence.
Impact on Patients Suffering from Fecal Incontinence
Fecal Incontinence (FI) and Accidental Bowel Leakage (ABL) are significant conditions that impact quality of life for many. StaySure is poised to change that narrative. Jonas explains, "StaySure represents the first truly practical and effective solution for many of those living with these challenging conditions. We are excited to bring this product to the people who need it most."
Proven Efficacy in Market Research
This device has been available in Europe since 2021 and has been clinically proven to be effective in managing FI and ABL. A recently completed clinical trial demonstrated the device's safety and efficacy, showing a significant reduction in the frequency of FI and an improvement in the quality of life for patients with frequent episodes. Full results are expected to be published soon.
A User-Centric Approach to Incontinence Solutions
Anthony J. Conway, Chairman and Founder of Minnesota Medical Technologies, emphasized the intention behind StaySure: "We designed StaySure to help people thrive in everyday life. This innovative solution is intended to help manage the symptoms of fecal incontinence and accidental bowel leakage." He explained that while most incontinence products aim to contain or absorb leakage, StaySure is designed to prevent ABL altogether.
Collaboration with Gastroenterology Experts
Developed in collaboration with leading gastroenterologists, the StaySure insert provides a hygienic solution that ensures a complete seal, effectively preventing ABL and associated odors. Its flexibility is a key feature, enabling it to conform comfortably to the body while providing reliable protection.
Company Background and Market Position
About Minnesota Medical Technologies: Headquartered in Stewartville, Minnesota, the company was founded by four industry veterans with over 100 years of combined experience in developing and marketing innovative silicone incontinence devices. Their expertise extends to successfully transitioning medical devices from concept to global market distribution.
Global Reach and Distribution
In Europe, StaySure is exclusively marketed and distributed by Wellspect Healthcare under the brand name Navina Insert, solidifying its reputation in the global market for innovative incontinence management solutions.
Frequently Asked Questions
What is the StaySure device?
StaySure is a disposable, self-inserted fecal incontinence device designed to provide comfortable and effective management of fecal incontinence and accidental bowel leakage.
How does StaySure differ from other incontinence products?
Unlike traditional incontinence products that focus on containment or absorption, StaySure is designed to prevent leakage altogether, offering a more innovative solution.
What materials is StaySure made from?
StaySure is crafted from 100% silicone and contains a specialized encased fluid for adaptability and comfort during use.
Is there clinical evidence for StaySure's effectiveness?
Yes, recent clinical trials have demonstrated StaySure's safety and efficacy in significantly reducing the occurrence of fecal incontinence.
How long has StaySure been available?
StaySure has been available in Europe since 2021 and has recently received FDA clearance for use in the United States.
