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Lumen Biomedical Announces the Successful Initiation of Its FiberNet(R) Carotid Embolic Protection US IDE Trial.


PLYMOUTH, Minn. -- Lumen Biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
, Inc. announced today the initiation of its EPIC (Evaluating the Use of the FiberNet Embolic embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism.

em·bol·ic
adj.
1. Relating to, or caused by an embolus or embolism.

2. Relating to emboly.
 Protection Device In Carotid Artery carotid artery
n.
1. An artery that originates on the right from the brachiocephalic artery and on the left from the aortic arch, runs upward into the neck and divides opposite the upper border of the thyroid cartilage, with the external and
 Stenting) U.S. IDE Feasibility Study. Dr. Gary M. Ansel of Riverside Methodist Hospital The Riverside Methodist Hospital is a religiously affiliated hospital located in Columbus, Ohio. Services
According to its website, the hospital provides the following programs and services:
  • Bariatrics (weight loss surgery)
 in Columbus, Ohio has successfully treated the first three U.S. patients with the FiberNet(R) Embolic Protection System during the procedures to place stents in their narrowed carotid arteries Carotid arteries
The four principal arteries of the neck and head. There are two common carotid arteries, each of which divides into the two main branches (internal and external).

Mentioned in: Endarterectomy
. The patients all recovered from their procedure without incident, and have been discharged from the hospital.

"The design of the FilterNet device is significantly different than any other embolic protection system in clinical practice today," said Dr. Ansel. "It truly appears to be the next generation of advanced distal protection devices. We have been impressed with its agility and flexibility, and have been amazed at the amount of debris that has been trapped and removed."

The FiberNet(R) Embolic Protection System is indicated to capture and remove embolic material produced while performing interventional procedures in vessels. Delivery of the FiberNet(R) Embolic Protection System is very similar to advancing a standard 0.014" steerable guidewire. This allows physicians to steer the device into difficult to access or past significantly stenosed stenosed /ste·nosed/ (ste-nozd´) narrowed; constricted.

ste·nosed
adj.
Marked by or showing stenosis; narrowed; strictured.



stenosed

narrowed; constricted.
 vessels. Once in place and deployed, it is a highly effective filter. The filter component of the system is composed of a three-dimensional mesh of PET fibers.

"Bench tests have demonstrated that FiberNet catches a significantly larger percentage of particles than other distal embolic protection filters", said Jason Galdonik, Director of Research and Development for Lumen Biomedical, "including particles less than half the diameter of those collected by the others on the market."

After the carotid artery stent has been placed, and the FiberNet filter has trapped the associated emboli emboli /em·bo·li/ (em´bo-li) plural of embolus.
Emboli
Plural of embolus. An embolus is something that blocks the blood flow in a blood vessel.
, the device is retracted into its own retrieval catheter under aspiration, and the entire system is removed from the patient.

Lumen Biomedical, Inc. is a start-up medical device company that was founded in 2003 to pioneer novel embolic protection technologies to dramatically reduce the incidence and severity of embolic events in a broad range of vascular applications.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jul 17, 2006
Words:345
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