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Mo.Ma device protects brain during carotid stenting
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Las Vegas — An investigational proximal flow blockage cerebal protection device may offer something that interventional cardiologists, radiologists, vascular surgeons and neurosurgeons do not have when stenting the carotid artery: The system can offer protection before crossing the lesion.
The Mo.Ma system protects the brain from embolization by two highlight-compliant atraumatic balloons, blocking antegrade blood flow from the common carotid artery and retrograde blood flow from the external carotid artery.
At the end of September, John Laird, MD, demonstrated the device at the Vascular Interventional Advances meeting held here.
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Source: Invatec, Inc. |
“The Mo.Ma device is one of only two proximal protection systems that are currently under investigation in the United States and around the world,” Laird told Cardiology Today. “All of the other embolic protection systems to date have been distal protection devices. The problem with those devices is that during the passage of embolic protection devices through the stenosis of the blockage, there’s a possibility of embolization. There’s a period in which the brain is not really protected during the procedure, whereas with the proximal protection, with the aortic-type clamping procedure, balloon inflation in the common carotid artery and in the external carotid artery, there’s protection throughout every step of the angioplasty and stenting procedure. Theoretically it is a better and safer way to treat some of these real difficult carotid lesions.”
Jack Springer, president of Invatec, said researchers have enrolled about half the 228 patients in the pivotal Investigational Device Exemption ARMOUR trial and plan to complete it in the beginning of 2009. The study is being conducted at 25 U.S. and European sites. Springer said the company hopes for FDA 510(k) with data approval by the end of 2009. The indication would be for the device to be used with any U.S.-approved stent on the market, Springer said.
Since it was introduced in the European market in 2001, the safety and performance of the Mo.Ma system has been reported in multiple clinical studies outside of the United States.
At the end of September, Italy-based Invatec formally announced its operations in the United States at the Vascular Interventional Advances meeting. The company has 35 products in 70 countries worldwide, and has a percutaneous transluminal angioplasty balloon product line and a thrombus management catheter available for sale in the United States. The company has also filed an Investigational Device Exemption application for FDA permission to begin clinical investigations for an iliac stent and plans to initiate several other trials over the next three years. — by Judith Rusk
The Mo.Ma device offers a different approach to protecting the brain. It allows a physician to do a completely protected procedure without ever crossing the stenosis before protecting the brain. The live case … was pretty impressive.
– Michael Jaff, DO
Cardiology Today Editorial Board memeber