Pulmonary Hypertension (PH) is a disparate family of disorders that have a similar cause - the inner layers of pulmonary blood vessels are dysfunctional. PH can occur as a primary disease or secondary to a number of respiratory and cardiac diseases.

It is both difficult to diagnose and easy to misdiagnose as symptoms are frequently masked by other medical conditions affecting the heart and lungs and often progress to advanced stages before being accurately diagnosed. Because drugs now exist that treat the underlying causes, it is essential for PH to be correctly classified according to etiology. This has proved difficult, as non-surgical methods are unavailable for obtaining endoarterial specimens necessary for biopsy analysis. This limitation represents a major drawback in the medical management of PH patients.

Although the true incidence of primary PH is unknown, prevalence in the U.S. population is estimated to be 14,000. Some 6,500-13,000 new cases arise each year due to the use of certain dietary appetite suppressants. The prevalence of secondary PH is conservatively estimated to be 2-4 million due to its close associations with common cardiovascular diseases such as chronic heart failure (CHF), and lung diseases including chronic obstructive pulmonary disease (COPD) and pulmonary embolism.

In pulmonary hypertension, it is unclear how or why some therapeutic interventions are effective and others are not. This often-fatal disease is defined symptomatically and hemodynamically, without a clear understanding of the underlying causes or mechanisms. Some patients respond temporarily to some therapies while other patients do not.

The endoarterial biopsy catheter has the potential to improve the understanding, diagnosis, staging, and treatment of patients suffering from primary and secondary PH. This can be accomplished by obtaining pulmonary endoarterial biopsy samples from these patients to explore the causes of their disease, properly diagnose their condition, classify them into responders and non-responders to different treatments based on biopsy analysis, and monitor their long-term response to therapeutic interventions.

In all patients, the unmet needs are great, as failure to accurately elucidate the molecular pathogenesis of disease contributes to deteriorating health and death for tens of thousands of patients per year. Vascular BioSciences is first to develop an endoarterial biopsy catheter that enables the routine pathological assessment of endoarterial histology and chemistry.

To download a PDF copy of our research on pulmonary vascular changes detected by the endoarterial biopsy catheter in an animal model of pulmonary hypertension published in Chest, please click here:
Percutaneous Pulmonary Endoarterial Biopsy in an Experimental Model of Pulmonary Hypertension by A. Rothman, M.D., D. Mann et. al. Chest. Vol. 114, No. 1. July 1998: 241-250. (Full Text-1.2 MB download)

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.