POM Medical Appoints bioaccess™ as Market Access and Regulatory Consultants in Colombia for its Panoramic Oxygen Mask – the Best Choice to Reduce Hypoxic Events
[ORLANDO, FL, MAY 11, 2018] - POM Medical, LLC ("POM") has appointed bioaccess.™ as its market access, regulatory consultant and legal representative in Colombia. bioaccess.™ will help POM conduct market research, build a distribution network, and obtain marketing authorization for its novel Panoramic Oxygen Mask at Colombia's medical device regulatory agency, INVIMA.
The Panoramic Oxygen Mask is a single patient, and disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.
The Panoramic Oxygen Mask is a multi-port mask that serves several functions: a) standard oxygen mask for when a patient requires supplemental oxygen; b) sampling of exhaled gases for monitoring, typically end-tidal CO2 for use in capnography; c) it has additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and the sampling of exhaled gases. The design of the Panoramic Oxygen Mask's oral or nasal membranes allow access of a scope and are soft and pliable to help maintain the oxygen concentration to the patient while having scopes, etc. inserted through the membranes.
Hypoxia is the condition in which the human body is lacking adequate oxygenation where the body tissues are depleted of oxygen. Hypoxia is an oxygen deficiency in the body. In the most severe Hypoxia cases, all oxygen is totally removed from the body which is a condition known as anoxia. Hypoxia directly affects the functions of the body, and some organs are more susceptive to the consequences of hypoxia than others.
Patients are subject to increased risk of hypoxia during gastrointestinal endoscopic procedures. Nearly 60% of upper endoscopy complications are related to hypoxia, respiratory distress, and cardiopulmonary adverse events. This continues to be a significant risk in the post-operative setting. Despite comprehensive monitoring, as many as 20% of patients can suffer hypoxia in the post-anesthesia care unit (PACU).
A recent study revealed that the Panoramic Oxygen Mask supplied an average oxygen concentration of 85% during procedural sedation as compared to a nasal cannula at 31% FiO2. This suggests that the Panoramic Oxygen Mask greatly reduces the risk of hypoxia.
The Panoramic Oxygen Mask is a versatile multi-port capnography mask that allows the insertion of most type of scopes, probes, and tubes through the mask and into either the mouth or nose. All this while maintaining a high percentage of oxygen delivered to the patient. The Panoramic Oxygen Mask maximizes oxygen delivery while providing sensitive and dependable end-tidal capnography detection for maximum patient safety. The Panoramic Oxygen Mask is ideal for procedures involving upper endoscopies (EGD, ERCP, EGD, EUBUS,), conscious sedation, nasal bronchoscopy, TEE, PEG, and fiber optic intubation (oral, nasal).
For more information on POM Medical and the Panoramic Oxygen Mask, please visit proceduraloxygenmask.com. On April 19, 2018, POM obtained the Food and Drug Administration (FDA) 510(k) clearance to market the innovative Procedural Oxygen Mask® (aka Panoramic Oxygen Mask) in the US.
About POM Medical
POM Medical, LLC is based in Simi Valley, California, USA and is the manufacturer of the innovative Panoramic Oxygen Mask.
Julio G. Martinez-Clark, CEO