#United States #FDA Approval #StaySure #Fecal Incontinence #Stewartville

StaySure™ Receives FDA Approval

Minnesota Medical Technologies recently celebrated an important milestone when its fecal incontinence device, StaySure™, received FDA 510(k) clearance. This device aims to improve the quality of life for millions who struggle with fecal incontinence (FI) and accidental bowel leakage (ABL).

The StaySure™ device is designed to be disposable, easy to use, and self-inserted, setting it apart from traditional incontinence solutions. Comprised of 100% silicone, the appliance features an encased fluid that allows it to adapt to the body seamlessly. Its soft shaft ensures a flexible structure capable of conforming to individual movements, and the external retainer provides a secure yet comfortable fit for users throughout their day.

David A. Jonas, the CEO of Minnesota Medical Technologies, expressed his excitement about this regulatory achievement, 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."

With over 20 million Americans suffering from FI, the introduction of StaySure™ is particularly timely. Jonas emphasized that StaySure™ represents not just another product, but a significant advancement in addressing the challenges associated with FI and ABL. In his words, "StaySure™ is a true breakthrough in the management of FI and ABL—and represents the first truly practical and effective solution for many of those living with these challenging conditions."

The device had previously been available in Europe since 2021, where it was clinically proven to be effective and safe. A recent clinical trial demonstrated its efficacy in significantly reducing the frequency of FI episodes and improving the overall quality of life for patients who experience frequent FI. The full results of this study are expected to be published later this year, further validating the device's effectiveness.

Anthony J. Conway, Chairman and Founder of Minnesota Medical Technologies, shared insights into the design philosophy behind StaySure™: "We designed StaySure™ to help people thrive in everyday life... While most incontinence products attempt to contain or absorb leakage, StaySure™ is different; it is designed to prevent ABL altogether." This innovative approach makes StaySure™ not only a practical solution but also a pioneering method for managing symptoms associated with FI.

The development of StaySure™ was a collaborative effort involving some of the leading gastroenterologists worldwide, ensuring that the product meets high medical standards. The device’s flexibility enhances its ability to create a complete seal, preventing ABL from the rectum and effectively eliminating any associated odors.

Founded in Stewartville, Minnesota, Minnesota Medical Technologies came together thanks to a team of four industry veterans, all of whom bring extensive experience in developing, manufacturing, and marketing innovative silicone incontinence devices. Their combined expertise positions the company strongly in the field of medical device development, particularly for incontinence management products.

"For more information on Minnesota Medical Technologies and its products, please visit www.mnmedicaltechnologies.com," concluded David A. Jonas, highlighting the company's commitment to enhancing the lives of those suffering from incontinence.

As this innovative device makes its way into the market, it will undoubtedly provide much-needed support and relief for those affected by fecal incontinence, helping them reclaim their confidence in daily life.