The US Food and Drug Administration (FDA) has recently granted 510(k) clearance to the SIMEOX 200 Airway Clearance Device, according to a press release from Goleta, California-based Inogen, Inc. The SIMEOX 200 is an updated version of the existing SIMEOX device, which is available in some international markets.
The SIMEOX 200 assists patients with chronic lung diseases that are characterized by excessive mucus hypersecretion and retention, such as bronchiectasis, COPD, and cystic fibrosis (CF). Using high-frequency vibrations and intermittent pressure to the airways during exhalation, the device helps improve bronchial clearance, according to the company.
Data from a randomized clinical trial published in 2023 suggested the original SIMEOX device may improve safe clearance of the airways in children with clinically stable CF under optimal therapy and could be an option in the chronic treatment of CF.1 The researchers concluded the results suggest that in conjunction with the optimal standard of care, the device may better manage CF in children by decreasing airway obstruction in proximal airways, maintaining lung clearance homogeneity and increasing physical functioning.1
Another 2023 study evaluating the home use of the SIMEOX device in patients with COPD demonstrated high levels of patient adherence and satisfaction.2
The approval of the SIMEOX 200 offers patients a new alternative to traditional airway clearance therapies. The device is approved for both health care settings and patients’ homes. A limited launch of the SIMEOX 200 is planned in select locations in 2025, according to the release.
References
1. Sands D, Walicka-Serzysko K, Milczewska J, et al. Efficacy of the Simeox® airway clearance technology in the homecare treatment of children with clinically stable cystic fibrosis: a randomized controlled trial. Children (Basel). 2023;10(2):204. doi:10.3390/children10020204
2. Hamidfar R, Murris-Espin M, Mahot M, et al. Feasibility of home initiation of an airway clearance device (SIMEOX) by telecare in people with non-cystic fibrosis bronchiectasis: a pilot study. BMJ Open Respir Res. 2023;10(1):e001722. doi:10.1136/bmjresp-2023-001722