Vascular BioSciences endoarterial biopsy catheter provides the means for facilitating new arterial therapies that would be very difficult to perform otherwise. The endoarterial biopsy catheter provides a minimally invasive, non-surgical means for obtaining vascular tissue for the initiation of ex vivo vascular-based gene therapy and for culturing customized autologous vascular grafts for patients requiring surgical vascular conduits.

Vascular-Based Gene Therapy
In vascular-based gene therapy, therapeutic genes are inserted into an arterial wall to treat disease. The endoarterial biopsy catheter could facilitate vascular-based gene therapy by obtaining autologous arterial cells in a minimally invasive fashion. The use of percutaneously procured autologous arterial cells for vascular-based gene therapy allows for gene insertion to be performed ex vivo (outside the patient). This minimizes systemic side effects associated with viral gene vectors, as well as immunological responses to gene therapy by utilizing autologous cells as the gene vector. Regardless of the method used to deliver therapeutic genes to cells, once genes have been delivered into the arterial wall, a biopsy sample could determine if the foreign gene has been incorporated into arterial cells and is actively expressing the desired gene products. The endoarterial biopsy catheter can also be used to determine if foreign genes have been incorporated anywhere else in the patient's vasculature, outside the targeted area.

Autologous Vascular Grafts
In addition to gene therapy, another revolutionary area of arterial therapeutics in which the endoarterial biopsy catheter could have an important impact is in the area of autologous vascular grafts. Researchers have performed experiments in which arterial cells and arterial conduits have been grown in vitro, in a cell culture, and then implanted in patients. After using the endoarterial biopsy catheter to obtain arterial cells percutaneously for cell culture, these cells could then be seeded on a bioabsorbable tubular polymer scaffolding for reinsertion into the patient. The result would be a replacement vessel composed of a patient’s own tissue for surgical implantation.

The endoarterial biopsy catheter will procure a sample of a patient’s vascular tissue for the cell culture of autologous vascular grafts. Immunological challenges associated with using nonautologous cell sources or synthetics for vascular grafts are avoided through the use of the endoarterial biopsy catheter to obtain the patient’s autologous tissue

Autologous vascular grafts from endoarterial biopsy samples for surgical implantation in patients.   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.