The National Evaluation System for health Technology Coordinating Center (NESTcc) Announces New Real-World Evidence Test-Cases Solicited from Across the Medical Device Community | Business Wire

The National Evaluation System for health Technology Coordinating Center (NESTcc) Announces New Real-World Evidence Test-Cases Solicited from Across the Medical Device Community | Business Wire

Yesterday the National Evaluation System for health Technology Coordinating Center(NESTcc) announced selection of FDA’s submitted proposal (test case) to study the benefits of using real-world data to better understand the safety profile of mesh used to treat Stress Urinary Incontinence. Stress urinary incontinence is a common condition among women, and negatively impacts patient quality of life, with an estimated 50% of patients experiencing some symptoms during their lifetime. When conservative treatments are inadequate, implantation of a mesh mid-urethral sling is a recognized minimally invasive surgical treatment.  However, there is uncertainty about adverse event rates for this procedure and indication.  Over the next year, the test case will explore if long-term real-world data from electronic health records can provide information to further the FDA’s understanding of adverse events associated with use of this device.

NESTcc Press Release Questions? If you have questions about this announcement, contact the Division of Industry and Consumer Education.