January 30, 2009 – Invatec this week announced it entered a worldwide distribution agreement with Lumen Biomedical Inc. to distribute the FiberNet Embolic Protection System (EPS), which received FDA clearance in November and CE Mark for use during carotid and saphenous vein graft procedures.
When the carotid arteries are obstructed, patients are at an increased risk for stroke, the third leading cause of death in the U.S. The FiberNet EPS captures debris released during the stenting procedure and prevents it from traveling to the brain, where it has the potential to cause a stroke.
The FiberNet system features a three-dimensional design composed of a matrix of fibers that entrap smaller particles and better overall capture efficiency compared to the currently available distal protection filters. The low-profile filter is mounted on a guidewire, needing no delivery system to cross the lesion. The FiberNet EPS will treat vessels ranging from 3.5 to 7 mm and its unique design ensures excellent wall apposition. After the particles have been captured, the FiberNet filter is retrieved into the retrieval catheter under aspiration and removed from the patient.
The FiberNet EPS was evaluated in the EPIC (Evaluating the Use of the FiberNet EPS in Carotid Artery Stenting) multicenter trial, which demonstrated the lowest stroke rates of any filter currently available in the U.S. market. As part of the trial, 237 high-surgical-risk patients with a critical carotid artery stenosis received carotid artery stenting. Overall, the 30-day stroke rate was 2.1 percent. There were no unanticipated adverse device effects. Visible debris was observed in over ninety percent of the procedures.
“The FiberNet EPS has several attributes including ease of use, low profile and the ability to conform to an irregular surface in the vessel wall, that have contributed to the impressive results and safety profile we observed in the EPIC trial,” said Dr. Subbarao Myla, medical director of cardiovascular research and endovascular intervention at Hoag Memorial Hospital in California and national principle investigator for the trial. “The device achieved the lowest stroke rate of any filter currently available, making FiberNet a top choice for physicians, and represents the next generation in embolic protection.”
Invatec’s carotid portfolio consists of the Mo.Ma Proximal Protection Device and the Cristallo Ideale Carotid Stent System, both of which have received CE Marks. In the U.S., Invatec currently has a pivotal investigational device exemption clinical trial called ARMOUR underway to assess the safety and efficacy of the Mo.Ma Proximal Protection Device for use in carotid stenting with FDA approved carotid stents.
For more information: www.invatec.us