VBS Interventional Advantages
VBS Interventional has created the endoarterial biopsy catheter to obtain biopsy specimens from the inner layers of an arterial wall via a minimally invasive technique. Endoarterial biopsy samples could make significant advances in diagnosing disease possible, aid in the optimization of medical management of patients, and provide a means for facilitating novel arterial therapies.
Presently, there is no means other than surgery to obtain endoarterial specimens for pathological analysis. The advantages of the use of the endoarterial biopsy catheter and the knowledge of vascular pathobiology obtained from endoarterial biopsy specimens are:
- Minimally invasive non-surgical procedure
- Improved diagnosis of disease
- Earlier intervention, before occurrence of advanced vascular remodeling
- Anticipation and avoidance of future adverse events through the early identification of biomarkers
- Better matching of treatment with disease, customization of therapies
- Pathological monitoring of patient response to therapeutic interventions
- Comprehensive profile of patient’s vascular pathological, cellular, molecular and genetic profile
- Increased patient survival and quality of life
- Decreased patient costs to third-party payers
- More precise patient selection for clinical trial recruitment
- Drug discovery and novel biomarker identification
- Precisely target drugs to specific proteins and receptors found in biopsies of diseased vasculature
- Patient arterial tissue for novel arterial therapies
Preclinical Studies
The arterial biopsy catheter has successfully and safely obtained endoarterial biopsy samples over 800 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. Single endoarterial biopsy samples have provided sufficient tissue for whole genome microarray analysis.
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.
