California-based Breathe Technologies was recently granted CE Certification for its Non-Invasive Open Ventilation (NIOV) System, a medical technology for patients with respiratory insufficiency diseases and neuromuscular diseases, which will allow the company to market and sell it in the European Union. The system also received the 2014 Product of Outstanding Interest (POINT) Award from the European Respiratory Society, which was awarded at this year’s International Congress, which took place last week in Munich, Germany.
With this recognition, the Breathe NIOV System is now the first and only wearable ventilation device designed for the therapy of patients who experience respiratory insufficiency to be granted a CE Certification. The system works by providing augmented tidal volume, enabling patients to reduce the effort needed to breathe. It can be used for patients with respiratory insufficiency caused by chronic obstructive pulmonary disease (COPD), including Alpha-1 Antitrypsin Deficiency.
“Receiving a CE Mark for our NIOV System is a significant milestone for Breathe Technologies and we appreciate the concurrent recognition from the European Respiratory Society,” said the president and CEO of Breathe Technologies, Larry Mastrovich. “We are now exploring potential commercialization partners for the EU and developing a European advisory board.”
Any medical device must receive CE clearance before being used in Europe, and the device had already been granted the European CE Full Quality Assurance System Directive 93/42/EEC for Medical Devices. It has been reviewed by AMTAC Certification Services Limited, Milton Keynes, UK, being authorized for the use of the CE 0473 mark for its NIOV System. The NIOV System was approved by the U.S. Food and Drug Administration in 2010, becoming by then also the first innovation in the ventilation category since 1998.
“Our experience with the Breathe Non-Invasive Open Ventilation System in the U.S. reaffirms the importance of ventilation with ambulation for people with respiratory insufficiency diseases including COPD,” explained Larry C. Casey, M.D., PhD, Mayo Clinic Health System, Franciscan Healthcare, La Crosse, Wisconsin. “I expect that the improvements in exercise duration and reduction in exacerbations seen among patients using the NIOV will resonate with physicians and patients in the EU.”
In addition, the awarding of the European Respiratory Society 2014 POINT Award recognizes the EU healthcare community’s confidence for NIOV System and, according to the company, is a sign of the uptake and impact the device will have in European markets. The award is granted by the ERS in order to encourage companies to invest in innovation and research on problems regarding modern respiratory healthcare.
The NIOV System has been studied in seven clinical trials, which demonstrated its effectiveness in reducing shortness of breath, increasing oxygenation, enhancing exercise endurance and unloading respiratory muscle activity. The purpose of the system is not only to be an effective therapy, but also a practical one. Therefore, the company sought to design the NIOV to be comfortable and enable patients to talk and exercise, reducing the overall size of the ventilation system and supporting patients’ mobility and independence.