The advantages of the endoarterial biopsy catheter and knowledge of vascular pathobiology obtained from endoarterial biopsy specimens would be:

Earlier diagnosis of disease

Earlier confirmation of disease

Earlier intervention, before occurrence of advanced vascular remodeling or tumor metastasis

Better matching of treatment with disease

Better management of disease via early and accurate identification of histological and proteomic markers

Better treatment monitoring

Minimally invasive procedure

Increased patient survival and quality of life

Decreased patient costs to third-party payers

Preclinical Studies

The arterial biopsy catheter has successfully and safely obtained endoarterial biopsy samples over 500 times in 8 years of pre-clinical animal testing.

Biopsy specimens have been made into histological preparations and examined under a microscope. Biopsy specimens have been used as parent tissue for cell cultures.

The mRNA levels of biospsy specimens have been quantitated by reverse transcriptase polymerse chain reaction.

Animals who have undergone the arterial biopsy procedure have easily been weaned off anesthesia, and have been noted to run and play a few hours after their catheterization.

Animals who underwent the arterial biopsy procedure showed no adverse clinical side effects acutely and upon follow-up four weeks after the procedure, histological examination showed minimal signs of localized arterial damage, and the sites of arterial biopsy appeared healed.

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.