MEDICAL DEVICE INNOVATION - Medical Device Daily
MEDICAL DEVICE INNOVATION - Medical Device Daily
MEDICAL DEVICE INNOVATION - Medical Device Daily
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70<br />
FDA clears cerebral protection<br />
device from Invatec for CAS<br />
By AMANDA PEDERSEN<br />
<strong>Medical</strong> <strong>Device</strong> <strong>Daily</strong> Staff Writer<br />
Patients with carotid artery disease – caused by plaque<br />
buildup in the carotid arteries that reduces blood flow – are<br />
at risk of a stroke because of the potential for clots to form<br />
on the plaque and block the blood flow. But carotid artery<br />
stenting (CAS), a procedure commonly used to treat the disease,<br />
also poses a risk of stroke because sometimes a piece<br />
of the plaque can break away and travel to the brain.<br />
That’s why companies like Invatec (Roncadelle, Italy)<br />
are developing cerebral protection devices that can be<br />
used during CAS procedures to prevent debris from reaching<br />
the brain. On Friday Invatec said it received FDA 510(k)<br />
clearance for its Mo.Ma Ultra Proximal cerebral protection<br />
device for use during CAS. According to the company, the<br />
device reduces and captures debris released during the<br />
stenting. The company also said it has completed the<br />
ARMOUR trial, which demonstrated low stroke and major<br />
adverse cardiac and cerebrovascular event rates.<br />
Jack Springer, president of Invatec USA (Bethlehem,<br />
Pennsylvania), told <strong>Medical</strong> <strong>Device</strong> <strong>Daily</strong> that most of the<br />
other protection devices on the market require the surgeon<br />
to cross over the lesion first before the protection device is<br />
inserted. That results in the opportunity to push or shoot<br />
debris into the brain via the blood stream, he said.<br />
Mo.Ma Ultra is a proximal protection device, which<br />
establishes full-time cerebral protection and control during<br />
the carotid stenting procedure prior to crossing the internal<br />
carotid artery lesion, thereby preventing distal<br />
embolization, Invatec said. Small balloons on the tip and<br />
proximal shaft are inflated in the external carotid artery<br />
and the common carotid artery to suspend blood flow during<br />
the stenting process. These balloons act like endovascular<br />
surgical clamps, protecting the brain during the procedure,<br />
according to the company.<br />
“Our device doesn’t require you to cross over the lesion<br />
first, it shuts down blood flow, stops flow into the brain so<br />
any debris ... would actually stop where the lesion is, where<br />
the problem is, and then you actually suck the debris out,”<br />
using a suction, or retrievable, catheter, Springer said.<br />
The percutaneous Mo.Ma Ultra requires no surgery,<br />
Invatec noted. Guide wires, stents and balloon catheters are<br />
<strong>MEDICAL</strong> <strong>DEVICE</strong> <strong>INNOVATION</strong> 2010<br />
used in this protected environment to treat the target<br />
lesion through the Mo.Ma Ultra device, which provides stability,<br />
control and access to the internal carotid artery like a<br />
guiding catheter or sheath. The suspended blood is then<br />
aspirated along with any embolic debris to complete the<br />
procedure safely, the company said.<br />
“The fundamental aspect of it is you create a protected<br />
and safe environment before you cross that lesion at all,”<br />
Chris Frederick, VP of marketing at Invatec USA, told MDD.<br />
“Therefore you’re not going to cause a potential emboli<br />
breaking off in your actual treatment of the patient.”<br />
W. L. Gore & Associates (Flagstaff, Arizona) makes a<br />
similar device that was approved earlier this year by the<br />
FDA. The Gore device is designed to reverse the flow of<br />
blood during stenting procedures. According to Gore, its<br />
neuroprotection technology reverses the flow of blood at<br />
the treatment site prior to crossing the lesion so there’s<br />
almost no chance that particles could escape to the brain.<br />
Springer said there has been a lot of research published<br />
on the concept of protection devices and that many experts<br />
believe these devices are the most important part of the<br />
CAS procedure and they create the highest risk. Thus, creating<br />
a protection device that doesn’t throw any debris into<br />
the blood stream is expected to make the stenting procedure<br />
safer.<br />
According to Invatec, results of the 262-patient<br />
ARMOUR trial support the safety and effectiveness of<br />
Mo.Ma Ultra for patients at high surgical risk for carotid<br />
endarterectomy undergoing CAS. Mo.Ma Ultra’s full-time<br />
protection and control contributed to a low 30-day stroke<br />
rate of 2.3% and complication rate of 2.7% in the primary<br />
endpoint 220-patient population set.<br />
“Proximal Embolic Protection is an important advance<br />
that gives us more options in the treatment of carotid<br />
artery disease,” said L. Nelson Hopkins, MD, of State<br />
University of New York (Buffalo) and co-principal investigator<br />
of the ARMOUR trial. “The Mo.Ma Ultra combines the<br />
advantages of carotid endarterectomy with the minimally<br />
invasive benefits of carotid artery stenting.”<br />
The Mo.Ma Ultra device is indicated as an embolic protection<br />
system to contain and remove embolic material<br />
(thrombus/debris) while performing angioplasty and stenting<br />
procedures involving lesions of the internal carotid<br />
artery and/or the carotid bifurcation. The reference diameter<br />
of the external carotid artery should be between 3 mm<br />
and 6 mm and the reference diameter of the common<br />
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