FDA Grants Vascular BioSciences HUD Designation to the Endoarterial Biopsy Catheter for Group 1 PH

 
 
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* Vascular BioSciences

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* Goleta - California - US

GOLETA, Calif. - Sept. 6, 2019 - PRLog -- Vascular Biosciences (VBS) received a Humanitarian Use Device (HUD) designation from the U.S. Food and Drug Administration (FDA) for the Endoarterial Biopsy Catheter (EABx) to take pulmonary artery biopsies in patients who have Group 1 pulmonary arterial hypertension (PAH).

"With cancer therapy, tissue and molecular diagnostics allow for successful targeted therapy approaches. But with PAH, we're unable to verify the earliest changes in the pulmonary vasculature, identify specific abnormalities, nor evaluate the success of treatments at the level of the affected tissue," said David Mann, CEO of Vascular BioSciences.

"Despite advances in drug therapy, the mortality of PAH patients continues to be very high. The endoarterial biopsy catheter is a tool that could 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. A modality for assessing the histologic and molecular characteristics of pulmonary vascular lesions in PAH could allow tailoring effective treatments to individuals, and could transform our understanding of the factors that contribute to the progression of disease. The endoarterial biopsy catheter being developed by VBS 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.

PAH can develop in association with other medical conditions including congenital heart disease, liver disease, HIV, and connective tissue diseases; it can even be associated with past or present drug use. While there are treatment options for PAH, there is no known cure.

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 EABx 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.

"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 founded to develop targeted solutions for serious and difficult-to-treat cardiovascular and inflammatory diseases in order to enhance and prolong human life.

More information about VBS is available at: http://www.vascularbiosciences.com

Email VBS CEO David Mann at dmann@vascularbiosciences.com or call at: (858) 273-2744

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