Respiratory Motion said today it won CE Mark approval in the European Union for its ExSpiron non-invasive patient minute ventilation monitor.
The ExSpiron patient monitor is designed to improve titration of opioids in postanesthesia care units and in general wards, and to alert attendants to respiratory depression in patientsadministered anesthetics during sedation cases, theWaltham, Mass.-based company said.
“Clinicians around the world rely on minute ventilation to make decisions on the respiratory status of patients on mechanical ventilators. ExSpiron is the only medical device able to provide this measurement in a patient monitor, offering immediate insight into a patients’ respiratory status than what is available in the market today. We are excited to bring minute ventilation monitoring to CE countries with the goal of helping clinicians more rapidly detect the onset of respiratory compromise,” CEO Dr. Jenny Freeman said in a press release.
The company said approval was based off data from 5 studies of the device. The ExSpiron was introduced in April at The Deutscher Anesthesia Congress.
“By showing each breath that is taken on a minute ventilation monitor, clinicians can immediately assess a patient’s work of breathing, and identify at-risk patients and provide early detection of low minute ventilation. This can enable my staff to adjust opioid dosing and ensure optimal pain management.”Dr. H.A. Tillmann Hein said in prepared remarks.
