FDA Grants Vascular BioSciences Humanitarian Use Device (HUD) Designation to the Endoarterial Biopsy Catheter for Group 1 Pulmonary Arterial Hypertension
Humanitarian Use Device (HUD) designation from the U.S. Food and Drug Administration (FDA) for the Endoarterial Biopsy Catheter (EABC) to take pulmonary artery biopsies in patients who have Group 1 pulmonary arterial hypertension (PAH).
“With cancer therapy, tissue and molecular diagnostics allow for very successful targeted therapy approaches. But with PAH we are not able to verify the earliest changes in the pulmonary vasculature, identify specific abnormalities expressed in an individual patient, nor evaluate the success of treatments at the level of the affected tissue,” said David Mann, CEO of Vascular BioSciences.
“I have been diagnosing and treating patients with pulmonary hypertension for the last 30 years. Despite advances in drug therapy, the mortality of patients with PAH continues to be very high, with an estimated survival of 60% at 5 years. A change in therapy paradigm is necessary. The endoarterial biopsy catheter is a tool that could eventually aid in pulmonary vascular molecular analysis which would help design individualized therapies,” said Abraham Rothman, M.D., professor at the University of Nevada School of Medicine, and Chief of Pediatric Cardiology at the Children’s Heart Center Nevada.
“Assessing treatment response in PAH is necessarily delayed and indirect, based on repeat hemodynamic measurements and functional responses. A modality for assessing the histologic and molecular characteristics of pulmonary vascular lesions in PAH could allow tailoring effective treatments to individuals based on tissue diagnoses and responses, and could transform our understanding of the factors that contribute to the progression of disease. The endoarterial biopsy catheter being developed by Vascular BioSciences would greatly facilitate these important developments for PAH care,” stated Paul B. Yu, M.D., Ph.D, Associate Professor of Medicine at Harvard Medical School, and cardiovascular medicine specialist at Brigham and Women’s Hospital.
The Endoarterial Biopsy Catheter is a medical device designed to obtain tissue samples from the inner layers of the arterial wall via a minimally invasive technique. Arterial biopsy samples acquired by the EABC can be analyzed histologically and via molecular analytical techniques in order to provide important information about current vascular disease status and possible clues about eventual disease progression.
According to the World Health Organization (WHO), Group 1 pulmonary arterial hypertension (PAH), is caused when the arteries in the lungs become narrowed, thickened, or stiff. Thus, the right side of the heart must work harder to push blood through these narrowed arteries. This extra stress can cause the heart to lose its ability to pump enough blood through the lungs to meet the needs of the rest of the body.
There are several types of PAH, two of which are Idiopathic PAH (IPAH) and Heritable PAH (HPAH). IPAH occurs without a clear cause, while HPAH is linked to genes that are inherited from family members. PAH can also develop in association with other medical conditions including congenital heart disease, liver disease, HIV, and connective tissue diseases — such as scleroderma and lupus. PAH can even be associated with past or present drug use, such as the use of methamphetamine or certain diet pills. While there are treatment options for PAH, there is no known cure.
“This is a major milestone in our continuing efforts to develop diagnostic solutions for group 1 pulmonary arterial hypertension patients. We are excited to continue making purposeful strides towards the first clinical use of the endoarterial biopsy catheter.” added David Mann, CEO of Vascular BioSciences.
About Vascular BioSciences
Vascular Biosciences is a biopharmaceutical and medical device company with operations in California and North Carolina, founded to develop targeted solutions for serious and difficult-to-treat cardiovascular and inflammatory diseases in order to enhance and prolong human life.
VBS has developed the Endoarterial Biopsy Catheter for the study, diagnosis, monitoring, and treatment of vascular-based diseases.
More information about VBS is available at www.vascularbiosciences.com
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