Broncus

Current emphysema treatments are generally limited to palliative measures that include supplemental oxygen, bronchodilators, anti-inflammatory drugs, and pulmonary rehabilitation. A small subset of patients with emphysema may undergo lung volume reduction or lung transplantation surgery, but these procedures are highly invasive and complex. Given the limited treatment options for emphysema patients, a minimally-invasive approach with the potential to reduce dyspnea could provide a meaningful clinical benefit.

The Airway Bypass procedure is performed under general anesthesia or deep sedation using bronchoscopy and the Exhale® devices that are inserted through the working channel of the bronchoscope.

First the Exhale Doppler System identifies the presence or absence of blood vessels at or near the site where the passage and stent are to be placed.

Once an area for passage creation is identified, the Exhale Transbronchial Dilation Needle catheter is advanced through the bronchoscope and the needle is extended to make a new opening in the airway wall. A second scan of this area with the Doppler Probe checks that there are no blood vessels nearby before the stent is placed.

The Exhale Drug-Eluting Stent is pre-loaded on a balloon delivery catheter, which expands to place the stent in the newly-made passage. The stent (3.3 mm inner diameter, 5.3 mm outer diameter, 2 mm in length when expanded) is composed of stainless steel and silicone that contains a drug, which is intended to keep the passage open over time.

Airway Bypass is an investigational bronchoscopic procedure in which newly-created extra-anatomic passages, reinforced with Exhale® Drug-Eluting Stents, connect the native airways to the damaged lung parenchyma, enabling the air trapped in the lungs to escape. The early results of the EASE (Exhale Airway Stents for Emphysema) Trial demonstrated that airway bypass could produce an acute reduction in air trapping with improvement in pulmonary function. However this benefit was not maintained to the 6 month endpoint of the trial so that strategies to extend the passage/stent durability are now under investigation. The Airway Bypass procedure is performed under general anesthesia or deep sedation using bronchoscopy and the Exhale® devices that are inserted through the working channel of the bronchoscope. First the Exhale Doppler System identifies the presence or absence of blood vessels at or near the site where the passage and stent are to be placed. Once an area for passage creation is identified, the Exhale Transbronchial Dilation Needle catheter is advanced through the bronchoscope and the needle is extended to make a new opening in the airway wall. A second scan of this area with the Doppler Probe checks that there are no blood vessels nearby before the stent is placed. The Exhale Drug-Eluting Stent is pre-loaded on a balloon delivery catheter, which expands to place the stent in the newly-made passage. The stent (3.3 mm inner diameter, 5.3 mm outer diameter, 2 mm in length when expanded) is composed of stainless steel and silicone that contains a drug, which is intended to keep the passage open over time.