Vasculitis can arise as a primary disease or as a secondary complication of autoimmune diseases. It is characterized by inflammation of the blood vessels. Vasculitis is often difficult to diagnose and is frequently confused with infections, toxic exposures, or hypertension. One form of primary vasculitis, Wegener's granulomatosis, can take up to 15 months to diagnose properly. Diagnosing pulmonary manifestations of collagen vascular diseases associated with systemic lupus or scleroderma can be equally problematic. As a result, the disease often progresses to advanced stages before being properly diagnosed.

Although the total incidence of collagen vascular disease and vasculitis is unknown, 20% to 85% of 2,000,000 lupus patients and 40,000 to 165,000 systemic scleroderma patients experience pulmonary vascular complications associated with their collagen vascular disease, and 9,000 to 14,000 Wegener’s granulomatosis patients experience granulomatosis in their pulmonary arteries. In all patients, the unmet diagnostic and therapeutic needs are great.

The endoarterial biopsy catheter will provide physicians with a powerful tool for determining the presence and characteristics of vasculitis or pulmonary vascular involvement in collagen vascular disease patients. Minimally invasive, outpatient endoarterial biopsy of involved pulmonary arteries would be a significant advance over current diagnostic techniques. The minimally invasive nature of the endoarterial biopsy procedure would provide a convenient and cost-effective means for disease diagnosis, customized therapies based on biopsy analysis, surveillance of the effects of therapeutic interventions and monitoring disease progression.

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.