Mercy TAPE moves closer to market

The FDA has approved the 510(k) application for the Mercy TAPE—an anthropometric-based device developed by Dr. Susan Abdel-Rahman at Children’s Mercy Hospital in Kansas City that predicts weight in children 2 months through 16 years of age. The results from the PTN study validating this device appeared in the Annals of Emergency Medicine in 2013.

Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification—also called PMN or 510(k). This step allows the FDA to review the scientific evidence generated related to safety and efficacy and determine whether the device is equivalent to an existing device. Because the Mercy TAPE is the first weight estimation device to be submitted to the FDA, the agency examined it against a standard medical scale and subsequently generated a brand new product code to classify such devices.

The 501(k) approval clears the way for the Mercy TAPE to be marketed and distributed once the commercial partner registers with the FDA. In the meantime, the ongoing Baby TAPE study is collecting the necessary anthropometric data on children under the age of 3 months, with the eventual goal of developing, designing, and validating a similar weight estimation tool for newborns and young infants. Results from this study are expected in 2016.

The PTN Mercy Method tape study locks its database

The PTN’s Mercy Method™ tape study has locked its database containing information from 625 patients. Database lock means that all clinical trial data have been reviewed, queries have been resolved and issues addressed, and the database cannot be altered in any way. The trial concluded enrollment in April of this year.

The Mercy Method™—developed at Children’s Mercy Hospital in Kansas City—estimates weight based on measurements of arm length and upper arm circumference using a novel measuring device designed for simple fabrication and use. The goal of the device is to guide delivery of age-appropriate, weight-based interventions, which remain the most accurate approach to delivering care in children.

The Mercy Method™ tape could also help to ensure that proper drug doses are administered to children under special circumstances, such as emergency medical care situations or in third world countries that lack suitable scales. This study is the first device trial undertaken by the Pediatric Trials Network. The trial team is currently preparing the clinical study report and hopes to submit the final version of the report to the FDA by the end of this year.

The PTN Mercy Method tape study completes enrollment

The PTN’s Mercy Method™ tape study has successfully completed enrollment of 625 evaluable patients. Trial enrollment was concluded in less than two months.

The study team attributes this impressive enrollment rate to the efforts of lead investigator Susan Abdel-Rahman, PharmD, of Children’s Mercy Hospitals and Clinics in Kansas City, Missouri; principal investigators Ian Paul, MD, of Milton Hershey Medical Center in Hershey, Pennsylvania, and Laura James at the University of Arkansas Medical Center in Little Rock, Arkansas; and their respective study personnel.

The Mercy Method™—developed at Children’s Mercy Hospital—estimates weight based on measurements of arm length and upper arm circumference using a novel measuring device designed for simple fabrication and use. The goal of the device is to guide delivery of age-appropriate, weight-based interventions, which remain the most accurate approach to delivering care in children.

The Mercy Method™ tape could also help to ensure that proper drug doses are administered to children under special circumstances, such as emergency medical care situations or in third world countries that lack suitable scales.

This study is the first device trial undertaken by the Pediatric Trials Network.