The Blowfish™ Transbronchial Micro-Infusion Device is an innovative broncho-adventitial drug delivery system that is ideally suited for use in interventional pulmonary procedures. In order to deliver a therapeutic agent into the bronchial wall and adventitia, the balloon is threaded through a bronchoscope, positioned at a pre-determined infusion site (such as a bronchial lesion) and then gently inflated so that it just touches the airway wall with 2 atmospheres of pressure but does not damage it. Inflation of the balloon results in the extrusion of a microneedle which punctures through the epithelium of the bronchial wall into the adventitia, but not beyond the cartilage layer. Therapeutic agents are then delivered directly to the adventitial region at the site of injury or stenosis.
The Blowfish™ Transbronchial Micro-Infusion Device has received 510(k) marketing clearance from the U.S. Food and Drug Administration and is CE Marked.
510(k) Intended Use: The Blowfish™ Transbronchial Micro-Infusion Catheter is intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or bronchial delivery into selected and sub-selected regions of the airway tree.
CE Mark Intended Use: The Blowfish™ Transbronchial Micro-Infusion Catheter is intended to deliver therapeutic and diagnostic agents into selected and sub-selected regions of the airway tree.