The CE mark approval allows commercialisation of ReddyPort Elbow across the European Union (EU) and other CE Mark geographies
ReddyPort, a US-based medical technology company has received Conformité Européene (CE) Mark approval for ReddyPort Elbow, its non-invasive ventilation (NIV) product.
The CE mark approval enables the company to commercialise its ReddyPort Elbow across the European Union (EU) and other CE Mark geographies.
In addition, the regulatory approval confirms that suite of solutions from ReddyPort and allows clinicians to perform procedures through the ventilation mask without interrupting therapeutic pressure and meets the requirements of the European Medical Devices Directive (MDD).
ReddyPort chief executive officer Scott Bostick said: “CE Mark is an important milestone and validation of our vision to make ReddyPort the standard of care for patients on NIV.
“CE Mark approval means we can help patients in Europe who struggle tolerating NIV therapy due to known issues while wearing the mask; dry-mouth, phlegm build-up, and difficulty communicating. ReddyPort Elbow and oral care products help improve tolerance, patient compliance, and comfort, leading to more successful NIV. Supporting a successful NIV is especially important now as clinicians need it most during the Covid-19 pandemic.”
ReddyPort Elbow features an elbow with self-sealing valve that reaches patient’s mouth
ReddyPort said that clinicians use NIV as the first line of therapy in respiratory insufficiency or failure commonly associated with COPD, CHF, asthma, pneumonia or ARDS. NIV intolerance may result in failure and escalation of care with mechanical ventilation.
The company claimed that its products will promote NIV success, by empowering clinicians and patients with simplified oral access without interrupting patient therapy.
The new NIV product ReddyPort Elbow comes with a unique elbow with self-sealing valve that provides access to the patient’s mouth.
When used in combination with ReddyPort NIV Maintenance Kit, the device enables cleaning and moisturising the patient’s mouth without needing to remove the mask.