Inogen’s SIMEOX 200 Airway Clearance Device for patients with chronic respiratory diseases has received 510(k) clearance from the U.S. Food & Drug Administration (FDA).
In a Dec. 30 new announcement, Goleta, California-based Inogen said the 510(k) clearance will be “expanding the company’s ability to market and meet the various needs of patients with chronic respiratory diseases in the U.S.”
The original Simeox system is currently available internationally. Inogen said the SIMEOX 200 is the “next generation” of that technology, “intended to promote and improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough.”
Among potential SIMEOX 200 users are patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as bronchiectasis, chronic obstructive pulmonary disease, cystic fibrosis or primary ciliary dyskinesia, Inogen said.
Inogen added that the SIMEOX 200 is an alternative to time-consuming traditional airway clearance therapies and “provides an innovative alternative, delivering efficient bronchial drainage, specifically in low lung volumes, that can be administered in health-care centers and institutions, as well as at home.”
“We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,” said Kevin Smith, Inogen president/CEO. “By tapping into our well-established network of health-care providers, B2B partners, and our direct-to-patient team, we aim to bring this next-generation airway clearance device to patients within the next year and significantly expand our reach over time.”
Inogen will “pursue a limited launch of SIMEOX 200 in targeted sites” this year.
