Atherosclerosis of the coronary arteries is the most prevalent of cardiovascular diseases and the principal cause of death in the industrialized world. While many patients may have the same diagnosis of atherosclerosis of the coronary arteries, there are important differences between patients.

Recent research shows that the greatest risk for mortality from coronary artery disease comes from soft plaque rupturing in coronary arteries that do not have obstructive narrowings. These arteries, which are otherwise open, contain soft plaque along their walls that when ruptured, results in blood clots, followed by heart attacks and often death. The research suggests that coronary artery disease is a systemic disease affecting the entire coronary vasculature.

Systemic approaches to cardiovascular disease include the prescription of pressure reducing, cholesterol lowering, and anti-clotting medicines. Patients have varying responses to medicines. For any given treatment, a significant percentage of people are non-responsive and will suffer increased morbidity and mortality as a result. In addition, a significant number of patients are given the wrong or insufficient medication resulting in adverse consequences for the patient and higher costs.

If physicians who make treatment decisions for their coronary artery disease patients know the histological profile of the patient’s vasculature, along with the DNA, RNA, protein, and receptor profiles for the patient’s diseased coronary arteries, they could make better treatment decisions. This could result in improved patient outcomes and more efficient use of medical resources.

The endoarterial biopsy catheter could improve the medical care of coronary artery disease patients by providing the means to differentiate between patients through the analysis of biological markers of inflammation, infection, cholesterol build-up, plaque rupture potential, or other proteins characteristic of coronary artery disease in endoarterial biopsy samples. With this knowledge, physicians could custom tailor the intervention to each patient’s coronary arterial characteristics resulting in improved clinical outcomes.

The endoarterial biopsy catheter could improve the medical care of coronary artery disease patients by providing the means to differentiate between patients through the analysis of biological markers of inflammation, infection, cholesterol build-up, plaque rupture potential, or other proteins characteristic of coronary artery disease in endoarterial biopsy samples. With this knowledge, physicians could custom tailor the intervention to each patient’s coronary arterial characteristics resulting in improved clinical outcomes.

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.