SOURCE: Restech

August 28, 2006 08:00 ET

Restech's Airway Reflux Detection System Passes Childproof Test in Pediatric Study

VENTURA, CA -- (MARKET WIRE) -- August 28, 2006 -- An innovative device for detecting gastric reflux in the airway was put to the test as Chris Landon, M.D., Chief of Pediatrics at Ventura County Medical Center, conducted a clinical study to test the efficacy of Restech’s Dx–pH Measurement System™ on infants and children.

The study features six patients, five of whom range in age from three months to nine years old, and the sixth, a 20-year-old with severe muscular dystrophy. Each patient was experiencing pulmonary manifestations of gastroesophageal reflux disease (GERD) including: Sleep apnea, asthma, hoarseness of the throat, pulmonary fibrosis and chronic cough, among others.

GER occurs when acid from the stomach flows up through the lower esophageal sphincter (LES) and into the esophagus. Reflux that escapes the upper esophageal sphincter (UES) into the oropharynx is deemed laryngopharyngeal reflux (LPR).

In the pediatric population, LPR has been implicated in the development of asthma, sinusitis, otitis media and sudden infant death syndrome. The absence of a device that can accurately detect reflux in the airway inspired Restech to develop the Dx–pH Measurement System.

“What’s exciting about this [Dx–pH Measurement System] device is that it is the first to measure and record pH in the oropharynx, and its positioning is ideal for detecting LPR in real-time,” asserts Dr. Landon.

Each patient was objectively assessed; depending upon symptoms and conditions, they were administered either a 24 or 48 hour test. The miniature 1.5mm diameter Dx–pH Probe™ was visually guided by a light emitting diode (LED) to a comfortable location in the airway posterior to the uvula. Thanks to a streamlined placement process, the children tolerated the test with minimal discomfort, a crucial refinement from conventional pH measurement catheters.

The youngest patient in the study, at three months, unknowingly became Restech’s poster child by displaying the most definitive results and proving an explicit need for the test. The child was admitted with cystic fibrosis, cough symptoms and posed a failure to thrive in his current state. An upper gastrointestinal (UGI) evaluation revealed no signs of GERD or anatomic obstruction, at which time Dr. Landon administered the Dx–System test for 24 hours.

While the infant tolerated the test exceptionally well, the results showed dramatic reflux events with dangerously low (acidic) pH levels. Dr. Landon recommended fundoplication surgery, the standard procedure for treating patients with severe GERD. After a post-surgery Dx–System test, the infant’s pH levels appeared healthy and consistent. The results revealed that the Dx–System test led to differential diagnosis of symptoms missed by the initial UGI.

Dr. Landon concluded, “The Restech Dx–pH Measurement System is an advanced ambulatory monitoring tool that fills a distinct void in the diagnosis of acid reflux.”

Restech is a privately held corporation specializing in the development of innovative respiratory medical devices. For more information on the Dx-pH Measurement System, call Debra Krahel or Wal Flicker at (800) 352-1512 or visit http://www.restech-corp.com.

Contact Information

  • For more information, call:
    Debra Krahel or Wal Flicker
    (800) 352-1512