Respinova Wins FDA OK for Airway Opening System Pulsehaler
That means it can be marketed as a safe and effective medical device to ease breathing in people with airway restrictions, such as chronic obstructive pulmonary disease (COPD).
“We are excited to bring this innovative technology to respiratory patients,” Cliff Ansel, CEO of Respinova, said in a press release.
“This FDA clearance for Pulsehaler is an important milestone for the company,” he added.
A 510(k) clearance is required when a device is marketed for the first time or when significant changes have been made to an already marketed device. Thus, Respinova had submitted a premarket notification to the FDA for the Pulsehaler — which the company said is a new type of device.
Small airways in the lungs lack the structural support given by cartilage that prevents their closure, according to Respinova’s scientists. Thus, these airways are completely dependent on elastic forces in the lungs to keep them open. If these forces decrease, as happens in COPD, the airways may collapse and gas exchange is hindered. Of note, gas exchange refers to the movement of oxygen from the lungs into the body tissues, while carbon dioxide is eliminated.
In the initial stages of COPD, the small airways open when air is drawn into the lungs. However, as the condition worsens, the airways only expand when the patient inhales deeply, and in time may fail to open altogether. When small airways collapse, not only is gas exchange affected, but mucous accumulates and is less efficiently expelled.
Unfortunately, since small airways have little or no smooth muscle, typical bronchodilators are not used as a treatment option.
Therefore, Respinova, a medical technology company based in Israel, developed Pulsehaler, a device that applies pulses of air pressure to expand small airways.
Pulsehaler uses patented dynamic multi-frequency pressure pulse technology. Pressure pulses that circulate quicker in the airways than in the surrounding tissue produce several temporary dilating forces that can successfully widen airways. At the same time, the device generates positive pressure when the patient exhales, which also helps with the opening of the airways.
According to Respinova, the pulses also can promote airway clearance by spreading and thinning the mucous layer in the airways of patients with respiratory diseases.
“Despite the available pharma treatments, patients with COPD, asthma, CF [cystic fibrosis] and other respiratory diseases unfortunately still suffer from poor quality of life,” said Raphael Breuer, MD, former head of the Institute of Pulmonology at the Hadassah University Medical Center, in Israel.
“Pulsehale brings a novel approach that will help patients with these conditions open their airways, which should improve their symptoms significantly,” Breuer said.
No additional information has yet been provided about the marketing for Pulsehaler.