MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Micrus, Flexible in j-v to make
cranial aneurysm therapy
By LYNN YOFFEE
Medical Device Daily Staff Writer
Micrus Endovascular (San Jose, California) and
Flexible Stenting Solutions (Eatontown, New Jersey)
have partnered to develop a flow diversion technology to
treat certain types of aneurysms.
Flow diversion is a fairly new approach in the treatment
of large and giant aneurysms, which represent 15% to 20%
of treated intracranial aneurysms.
Robert Stern, president/chief operating officer, told
Medical Device Daily that, “We’ve been discussing publicly
the need for potential flow diverter devices for three years.
We’ve been looking at these technologies for longer than
that. There are larger form aneurysms that need a treatment
paradigm that’s more advanced than coils. Coils are
very safe and effective. These devices would be used in
complicated cases. It’s for a small subset of all aneurysm
cases.”
Treatment of aneurysms – a weak spot on a blood vessel
in the brain that bulges out and fills with blood – can
involve the use of tiny coils that fill the aneurysm sac, eliminating
it from the cerebral circulation in a less invasive
manner. But flow diversion is an even newer approach in
which stent-like devices are placed in the parent vessel.
They serve to divert blood flow away from the aneurysm so
that it can heal.
A patient who needs treatment for an aneurysm is typically
evaluated to determine if the bulge should be clipped
surgically or if an endovascular procedure is warranted,
one that coils the lesion. Micrus already makes a MicroCoil
delivery system.
“If you think of a pipeline that has in the middle a softening
of the walls,” he said. “Those walls bulge outward,
weaken and you get this hideous bump. What you want to
do is bypass the bulging segment with a flow diverter. It
takes the pressure off the vessel wall in that section and
allows for the safe diversion of flow, giving you another
opportunity to treat this. In the past they stented across
and put coils in. In some cases, we still may need to use
coils.”
What Flexible Stenting brings to the table is technology
that facilitates this flow diversion technique.
“If you have an outward-bulging or inward-bulging vasculature,
the right-handed and left-handed design made by
Flexible Stenting may bring unique flow diversion properties
to the table,” he said. “It’s a very flexible design and
should give us good wall coverage.”
In the new deal, Micrus will handle the regulatory and
clinical processes and will manufacture neurovascular
products that emerge from this collaborative agreement.
The new Flexible Stenting Solutions platform will
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include a self-expanding stent design that will provide
more accuracy in delivery; porosity and flow diversion control
based on a unique design pattern; increased flexibility
during delivery and post-placement vessel conformability;
allow for post-placement coiling if necessary; and includes
a special coating that is intended to reduce the potential for
thrombogenicity and stenosis.
John Kilcoyne, chairman/CEO of Micrus Endovascular,
said, “We expect that our jointly developed technology will
be used to treat wide-neck and fusiform aneurysms, as well
as other types of clinical situations that currently are not
adequately treated with either surgical or endovascular
techniques.”
Stern declined to review specifics about the deal, but
did say that, “We will make an up-front licensing payment
and payments based on certain milestones such as
European CE mark and FDA clearance. Flexible Stenting
Solutions will earn a royalty on everything we sell.”
Stern declined to project a development timeline other
than to say the platform is already developed and now
must be optimized.
(This story originally appeared in the Aug. 25, 2009,
edition of Medical Device Daily)
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