Sponsor no longer pursuing regulatory approval of investigational device

A new artificial lung device has been developed that potentially provides added support to mechanical ventilation for severely damaged lungs. The Hattler Respiratory Assist Catheter is designed to provide gas exchange (deliver oxygen and remove carbon dioxide) for a period of up to 7 days, providing more time for the lungs to improve.

Extrapolating from large animal data, the hypothesis is that the Hattler Catheter will be capable of providing 30% to 40% of the basal requirements of carbon dioxide exchange in a manner that is dependable and reproducible.

The Hattler Catheter Respiratory Assist Device consists of a Catheter and a drive console. The catheter consists of a bundle of polypropylene hollow fibers (approximately 1000) in 30cm or 35cm length surrounding a helium filled balloon. The balloon is similar to an Intra-Aortic Balloon, however, it is pulsed at 300 beats per minute, while IABP typically operate at 120 bpm. The hollow fibers are similar to fibers utilized in external oxygenators for cardio-pulmonary bypass. No device exists on the market in which fibers surround a balloon, and no device exists on the market in which the hollow fiber bundle is designed to be inserted into the venous system, i.e., the vena cava. External oxygenators are designed to be used in an extracorporeal circulatory loop.

The Hattler Catheter drive console provides the power to drive the helium filled balloon while removing excess oxygen and carbon dioxide from the venous system via the catheter.

Inclusion Criteria:

• Both sexes, 18 years and older
• Have a terminally ill disease process
• On maximum ventilator support
• Intubated and unconscious
• Swan Ganz in place
• Hypoxic
• Unsuitable for organ donation

Exclusion Criteria:

• Circulatory shock (< 80 mmHg) and unresponsive to drug therapy and volume replacement
• Pregnancy
• Morbid obesity > 182 kg
• Weight < 41 kg
• History of bleeding disorders with contraindication to heparin
• Have a disease process with a contraindication to heparin
• Known internal jugular or femoral vein complications or abnormalities
• Known inferior vena cava (IVC) filter in place