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The catheter was tested in the pulmonary arteries of normotensive animals in order to determine initial feasibility, safety and effectiveness of the device at normal arterial pressures. Please see Transvenous Procurement of Pulmonary Artery Smooth Muscle and Endothelial Cells Using a Novel Endoarterial Biopsy Catheter in a Canine Model by A. Rothman, M.D., D. Mann et. al. Journal of American College of Cardiology. Vol. 27, No. 1. January 1996: 218-224 . (Full Text-5.6 MB download)

An animal model of pulmonary hypertension was created by monthly infusions of ceramic microspheres to occlude pulmonary vessels and increase pulmonary arterial pressure. Please see Percutaneous Pulmonary Endoarterial Biopsy in an Experimental Model of Pulmonary Hypertension by A. Rothman, M.D., D. Mann et. al. Chest. Vol. 114, No. 1. July 1998: 241-250. This animal model was developed in order to test the safety and effectiveness of the device at elevated pressures and to study the progressive changes that occur in pulmonary vasculature through the use of a new tool, the endoarterial biopsy catheter. (Full Text-1.2 MB download)

An animal model of lung transplantation was created in order to determine if VCAM mRNA in pulmonary arterial biopsy samples could be a marker of transplant rejection. Please see Increased Expression of Endoarterial Vascular Cell Adhesion Molecule-1 mRNA in an Experimental Model of Lung Transplant Rejection: Diagnosis by Pulmonary Arterial Biopsy by A. Rothman, D. Mann et. al. Transplantation. Vol. 75, No. 7. April 15, 2003. This animal model was developed to demonstrate that endoarterial biopsy samples obtained in a lung transplant model of organ transplant rejection would show an increase in VCAM mRNA levels with increasing rejection. RT-PCR analysis of endoarterial biopsy specimens assessed the allo-immune response on the pulmonary vasculature, which is the first point of contact between the recipient's immune system and the donor organ. Endoarterial biopsy samples could be useful in the surveillance and early diagnosis of lung transplant rejection. (Full Text-648k download)

CAUTION - Investigational Device. Limited by Federal law to investigational use.
This device should be used only by physicians with a thorough understanding of percutaneous interventional procedures.