Food And Drug Administration Grants Clearance For ReddyPort's NIV Access Elbow
SALT LAKE CITY, March 15, 2018 /PRNewswire/ -- ReddyPort Inc. announced today that it received United States regulatory clearance from the Food and Drug Administration (FDA) for its ReddyPort NIV Access Elbow (www.ReddyPort.com). The ReddyPort Elbow is the first multiple-use access elbow that attaches to noninvasive ventilation (NIV) masks. The ReddyPort Elbow, when used with ReddyPort NIV products, provides a variety of therapies to be delivered to patients without disrupting therapeutic pressure.
"The ReddyPort Elbow offers a new paradigm in the treatment of patients undergoing NIV therapy," explained Andrew Hansen, CEO of ReddyPort. "The ReddyPort elbow has a large access valve enabling clinicians to use ReddyPort NIV products and provide care, without taking the mask off."
ReddyPort has a platform of unique NIV Products designed to work with the ReddyPort elbow. The ReddyPort Oral Care Kit allows patients to receive routine oral care while maintaining pressure in the mask. The ReddyPort Microphone Kit is a speaker/microphone system that amplifies a patient's voice, allowing patients to communicate with their clinicians and loved ones during NIV. The ReddyPort Nebulizer is a fully enclosed vibrating mesh nebulizer designed to go through the ReddyPort Elbow, bypassing the ventilation circuit. The ReddyPort Capnography Adapter is a gas sampling system that allows for accurate CO2 sampling through the mask during NIV therapy. ReddyPort's NIV Products, for use with the ReddyPort Elbow, are subject to future regulatory review.
"We believe the ReddyPort platform will significantly improve the care and comfort of patients undergoing NIV therapy," said Dr. Chak Reddy, the company's chief medical officer and a co-inventor of the technology. "Standardized oral care will help to further reduce cases of ventilator-associated pneumonia while the other ReddyPort-enabled procedures will improve care decisions and overall wellness of the patient."
"The ReddyPort NIV Access Elbow is currently adapted for the Respironics AF531 and Performax series masks but we are currently developing the elbow for many other NIV masks on the market. We hope to provide this unique care platform on all masks and to all patients undergoing NIV therapy in the future," said Andrew Hansen.
ReddyPort will be showcasing it's ReddyPort NIV Access Elbow and NIV products at the upcoming American Association of Critical-Care Nurses Critical Care Exposition, from May 20-24, 2018 in Boston. For more information, please visit the ReddyPort website, www.reddyport.com.