Healthcare Industry News:  Balloon catheter 

Devices Neurology Interventional

 News Release - May 30, 2007

CoAxia(TM) Announces First Patients Enrolled in Study Extending Treatment for Acute Stroke Up to 24 Hours

Flo 24 feasibility study complements ongoing SENTIS 10 hour pivotal study

MINNEAPOLIS, May 30 (HSMN NewsFeed) -- CoAxia, Inc. of Maple Grove, MN, today announced enrollment of the first two patients in its Flo 24 safety and feasibility study of NeuroFlo(TM) Perfusion Augmentation Therapy in ischemic stroke patients who present for treatment as late as 24 hours after stroke onset. NeuroFlo is believed to be the first intervention evaluated which attempts to improve blood flow to the brain this late after a stroke.

Maxim Hammer, MD, Director of Clinical Research at the University of Pittsburgh Stroke Institute who enrolled the first patient in the trial commented, "We are pleased to extend the evaluation of NeuroFlo treatment in patients up to 24 hours. These are patients who usually do not qualify for treatments aimed at reopening blocked arteries in the brain, because these treatments tend to be risky after the first few hours. It is exciting to be part of a clinical trial with NeuroFlo, an alternative approach to treating stroke. In most hospitals our patient would have had no option for treatment. The NeuroFlo treatment was delivered with no adverse events and with clinically noticeable improvement."

David S. Liebeskind, MD, Associate Neurology Director of the UCLA Stroke Center who with his colleagues enrolled the second patient added, "Our case tells a story of a new era in stroke, where advanced imaging with CT or MRI can select optimal candidates for aggressive interventions, many hours beyond traditional time windows, to reverse the devastating consequences of stroke. On a daily basis, people awaken with stroke symptoms or arrive at an emergency room far beyond the time limitations of approved stroke treatments. Imaging of collateral blood flow downstream from a blocked artery, and enhancing that flow with the NeuroFlo treatment may result in dramatic improvements in neurological function and limit the extent of brain damage even when the artery remains blocked."

In addition to the Flo 24 study, CoAxia is conducting a randomized pivotal trial, SENTIS, which is evaluating the NeuroFlo treatment in patients up to 10 hours after the onset of their symptoms. The SENTIS trial has now enrolled over 65 patients at more than 20 major medical centers.

The NeuroFlo treatment is intended to deliver blood to the affected area of the brain by providing an increase in blood flow via alternative, collateral pathways around the blocked artery. The therapy is accomplished with a unique, dual-Balloon catheter placed in the descending aorta that works by restricting flow in the descending aorta and thus increasing blood flow to the brain.

Andrew M. Weiss, President and CEO of CoAxia added, "We are pleased that Flo 24 enrollment is now underway at several of the top stroke institutions in North America. Together with our other studies, we are now evaluating our NeuroFlo technology in patients from 0-24 hours post stroke, representing a large segment of the annual ischemic strokes worldwide."

CoAxia, Inc. is a venture-backed, privately held, development-stage company focused on providing perfusion augmentation therapies that improve outcomes for patients with cerebral ischemia resulting from stroke, vasospasm and other conditions.

Source: CoAxia

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