Respiratory Technology Corporation (dba Restech) announced today that its revolutionary Dx-pH Measurement System™ has received CE Mark approval, allowing introduction to the European Union and all countries recognizing the CE Mark. This approval from the European Union certifies Restech has met EU health, safety and environmental requirements that ensure consumer safety.
Restech’s Dx-System provides valuable information about patients’ pharyngeal acid exposure and its role in various comorbidities, helping physicians diagnose the cause of the patient’s symptoms more accurately, and treat the patient more effectively.
Now, with the CE Mark approval, the Dx-pH Measurement System is available to physicians throughout Europe who have recognized a need for this technology for several years especially after an alarming increase in the incidence of gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux disease (LPRD) over the last two decades.
“The CE Mark approval is a result of our efforts and desire to bring this much needed technology to physicians worldwide,” said Leo R. Roucher, CEO, Restech. “In response to requests from the international community, we can now provide the technology to help diagnose and treat patients more quickly, comfortably and effectively.”
Ruling out acidic or alkaline reflux when determining etiology of chronic cough, recurrent laryngitis, sinusitis, and respiratory conditions is very important. Instead of empirically prescribing medications to inhibit reflux, based on symptoms with no real evidence-based diagnosis, doctors can now easily determine whether reflux is or isn't a factor.
The Restech Dx–pH Measurement System is a revolutionary system that comfortably measures pH in the airway. Gastric reflux in the upper airway, or laryngopharyngeal reflux, commonly takes a gaseous form that cannot be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx–pH Probe is unique in its ability to measure pH in a non-liquid environment, such as the pharynx. By monitoring the pH levels in the pharynx, the Dx–System enables physicians to confirm or deny the presence of laryngopharyngeal reflux, and evaluate it as a possible contributor to their patients’ symptoms.
The Dx–pH Probe’s miniaturized, patented sensor is housed in the tear-drop shaped tip at the distal end of a thin trans-nasal catheter. An LED blinks during placement, allowing the medical personnel to confirm the proper placement in the oropharynx. The small size and minimally invasive position of the Restech Dx–pH Probe allows patients to carry on normal, everyday activities including eating, talking and sleeping with more comfort than conventional esophageal pH probes.
The measurements taken by the pH sensor are sent wirelessly to a recording device which the patient carries throughout the study period. Upon completion of the study (usually 24 hours), the patient returns to the physician’s office where the data is downloaded and presented graphically for analysis using Restech’s custom Dx–pH DataView software.
Restech is a leader in engineering world class medical technologies that provide comfortable, reliable solutions to assist physicians in the diagnosis of reflux related health problems quickly and reliably. The innovative engineering team at Restech is led by professionals with over two decades experience each in medical device development. Together, the Restech staff hold over 30 patents in the areas of sensor technology, data recording & monitoring systems, and other medical devices.
For more information on the Dx-pH Measurement System, please contact Ms. Debra Krahel of Restech (+1-858-673-3700 or firstname.lastname@example.org), or visit http://www.restech.com.