MEDICAL DEVICE INNOVATION - Medical Device Daily

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NeuroInterventions aims to
deliver faster stroke care
By AMANDA PEDERSEN
Medical Device Daily Staff Writer
In the business world the old cliché is that “time is
money.” In the world of stroke treatment, that expression
becomes “time is brain,” – and it is the driving principal
behind one early-stage company’s quest to speed up the
delivery of post-stroke countermeasures in order to minimize
brain damage.
Michele Migliuolo, president/CEO of
NeuroInterventions (NIT; Pittsburgh) described the
development in a presentation at AdvaMed 2009 in
Washington. He says the technology enables surgeons to
reach and remove clots in much less time than conventional
approaches.
“When a patient stuffers a stroke – and by stroke I mean
ischemic stroke – [there is a] time window of about nine
hours in which something can be done to help that patient,”
Migliuolo told Medical Device Daily.
He noted that stroke is the third most frequent cause of
death and the number-one cause of permanent disability.
“Every second can mean a drop in brain function,” when a
clot blocks the flow of oxygen-rich blood in the brain,
Migliuolo said.
“Even after a patient reaches a hospital, it can take up to
60 minutes just to introduce a conventional catheter
through the femoral artery and steer it to the site, before
you can deal with the clot,” he said.
According to NIT, its system, which is capable of dissolving
or extracting clots and delivering medication, takes
a shorter, faster path to the brain. With “exceptional maneuverability
for negotiating the circulatory system,” the company
said its devices “will benefit patients, physicians, hospitals
and insurance companies by improving outcomes
through shorter, more effective treatment; by permitting
more complex procedures; and by reducing recovery
times.”
Migliuolo declined to explain to MDD how the patentpending
technology works. However, he said that following
his presentation at AdvaMed he was approached by three
potential new investors who wanted to learn more about it.
NIT says it is prototyping a family of patent-pending
catheters for addressing deep vein thrombosis, carotid
stenting, and traumatic brain injury, in addition to stroke.
The technology also facilitates localized drug and stem cell
delivery, the company noted.
The company is hoping to begin testing its devices in
animals in January or February of 2010, Migliuolo said.
NIT says that three medical professionals who “realized
that simpler and easier to use thrombectomy devices could
potentially have a dramatic effect on patient outcomes”
founded the company in December 2007.
MEDICAL DEVICE INNOVATION 2010
The company’s management team includes Lawrence
Wechsler, MD, chair of the Department of Neurology and
director of the Stroke Institute at the University of
Pittsburgh Medical Center (UPMC); Mark Wholey, MD,
founder and director of the Pittsburgh Vascular Institute;
Tudor Jovin, MD, co-director of the Center for
Neuroendovascular Therapy at the UPMC; Ender Finol, PhD,
associate research professor for the Institute for Complex
Engineered Systems and Biomedical Engineering
Department at Carnegie Mellon University (Pittsburgh); and
Migliuolo, a high-tech entrepreneur and former executive
in residence at the Pittsburgh Life Sciences Greenhouse.
Until recently the only FDA-approved drugs to treat
ischemic stroke – Genentech’s (South San Francisco,
California) tissue plasminogen activator (tPA) – had to be
given within three hours after the onset of symptoms and
the majority of patients miss that window of opportunity to
receive the clot-busting drug. But in June the American
Heart Association (Dallas) extended the tPA treatment window
for stroke patients based on studies proving that the
drug could be given to suitable candidates up to 4.5 hours
after symptom onset.
Still, several companies are working to widen the treatment
window for ischemic stroke patients even more. Last
year Penumbra (San Leandro, California) received FDA
clearance for its Penumbra system – a drug-free approach
that can be used up to eight hours after symptom onset.
The Penumbra system is a package of tools used by
neuro interventional specialists to remove occlusions from
the large vessels of the brain that are causing an acute
ischemic stroke. It works on the proximal surface of the
occlusion, optimizing safety and eliminating the need for
navigation beyond the occlusion, according to the company.
The system is comprised of an aspiration platform containing
multiple devices that are size-matched to the specific
neurovascular anatomy allowing clots to be gently
aspirated out of intracranial vessels.
The Penumbra system is indicated for use in the revascularization
of patients with acute ischemic stroke secondary
to intracranial large vessel occlusive disease within
eight hours of symptom onset.
CoAxia (Maple Grove, Minnesota) also is trying to give
ischemic stroke patients more time to get treatment with
its NeuroFlo Perfusion Augmentation Therapy. Over the
summer the company reported continued enrollment in its
SENTIS pivotal trial of its NeuroFlo technology for acute
ischemic stroke (MDD, June 24, 2009). The company said at
that time that it had enrolled more than 75% of its goal of
about 500 patients, with enrollment expected to conclude
in early 2010, and PMA submission later that year. The company
also reported then that it had completed two pilot
studies of its NeuroFlo catheter in additional stroke patient
populations – those treated as late as 24 hours after stroke
onset and those who received NeuroFlo treatment in conjunction
with intravenous tPA.
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