By viewing this page you recognize that this product is approved for non-US residents only.

Therapeutic Use

Given the potential efficacy of the Lung Flute^® with respect to mobilizing deep lung secretions based on diagnostic data, we are commencing a therapeutic clinical trial at the Buffalo N.Y. VA hospital in the Autumn of 2007. Depending on the results of this clinical trial, the Company hopes to submit a FDA 510(k) application for therapeutic use in 2008. If successful, this clinical trial will support the use of the Lung Flute^® as an effective modality for improved treatment of pulmonary congestion.

Subject Protocol

40 COPD subjects divided into 2 groups:
- Predicate device therapy group
- Lung Flute^® therapy group
Subjects will be assessed at regular intervals
2 months in duration

Assessment Tools

At regular intervals the following will be assessed:
- Pulmonary function test
- Resting oximetry
- Six minute walk
Subjects will complete a Visual Analogue Dyspnea Scale at regular intervals