- Studies show the ExSpiron's quantitative measurements of respiration demonstrate value in a number of clinical settings
- Company receives additional FDA Clearance
Data supporting the accuracy and utility of the new ExSpiron 1Xi monitoring system continues to mount with presentations at major medical conferences. At the International Anesthesia Research Society Meeting held May 4-7 in San Diego, CA, four separate presentations demonstrated the ExSpiron system's utility in a variety of intra-operative and post-operative settings. Respiratory Motion conducted studies with physicians from Massachusetts General Hospital and Tufts Medical Center in Boston, MA, and Vidant Medical Center in Greenville, NC. Clinicians presented data that showed the ExSpiron is able to report dangerous decreases in respiration—and apneic episodes—following narcotic administration in both cardiac and orthopedic surgery patients.
Additionally, compelling new data from studies conducted at Massachusetts General Hospital, Tufts Medical Center and The University of Vermont has been accepted for presentation at the prestigious American Society of Anesthesiologists conference to be held in San Francisco October 12th-15th, 2013.
"We have never before been able to quantify the influence of pain agents on the respiratory system with such fidelity," reported Gary Mullen, M.D., a practicing anesthesiologist at Vidant Medical Center and a study author. "This new information will enable us to alter care and potentially avoid respiratory distress well before current technologies would signal a problem."
Monitoring the respiratory status of patients after opioid administration is challenging, in particular with obese and elderly patient populations. This novel method of providing minute ventilation data, previously only available on ventilated patients, is consistently proving to be valuable by helping clinicians quantify respiration in a variety of clinical settings.
Respiratory Motion, Inc. also reported its recent 510(k) clearance from the US Food and Drug Administration (FDA) for its follow-on ExSpiron 1Xi respiratory monitoring system. This clearance covers the latest generation of the device and its proprietary PadSet.
To accommodate its recent product launch, Respiratory Motion has relocated and completed its planned expansion of the manufacturing facility in Waltham, Massachusetts.
Jenny Freeman, M.D., CEO and founder, stated, "The convergence of the clinical evidence with our FDA clearance has positioned us well to accelerate our product launch. Both the acceptance of our data by prestigious medical societies and the positive response from the clinical community support our fundamental belief that our technology fills a clear unmet need and will improve patient safety."
The ExSpiron is available now for clinicians in the initial hospital settings of anesthesia/OR, post-op recovery, procedural sedation and intensive care units.