FDA Grants 510(k) Clearance to Pulsehaler for Respiratory Disease Relief

The US Food and Drug Administration (FDA) has given 510(k) clearance to Pulsehaler™, a device developed by Respinova Ltd. to help facilitate the opening of airways and provide clearance of secretions for patients with respiratory diseases.

The device is the first to use patented Dynamic Multi-frequency Pressure Pulse™ technology, which utilizes an internal turbine and multi-frequency disc to send air pressure pulsations directly into the lung. As such, this provides benefit for those with airway restrictions.

"Despite the available pharma treatments, patients with COPD, asthma, CF and other respiratory diseases unfortunately still suffer from poor quality of life," noted Professor Raphael Breuer, MD, former Head of the Institute of Pulmonology at Hadassah University Medical Center, in a statement.

"Pulsehaler™ brings a novel approach that will help patients with these conditions open their airways, which should improve their symptoms significantly,” Breuer said.

A cross-over controlled, double-blind study showed that the non-invasive device significantly improved 6-minute walk distance, as well as FVC and IC lung function, in patients with COPD. These results were superior when compared with placebo (P<.001).

Further, patients experienced a significant improvement in Dyspnea and Mastery quality of life questionnaire scores.

According to Cliff Ansel, CEO of Respinova Ltd., this FDA clearance represents a major milestone for the medical technology company. Prior to approval, the device had not been cleared or approved for sale and marketing by any regulatory agency.