Healthcare Industry News:  steerable guidewire 

Devices

 News Release - July 17, 2006

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

PLYMOUTH, Minn.--(HSMN NewsFeed)--July 17, 2006--Lumen Biomedical, Inc. announced today the initiation of its EPIC (Evaluating the Use of the FiberNet Embolic Protection Device In Carotid Artery Stenting) U.S. IDE Feasibility Study. Dr. Gary M. Ansel of Riverside Methodist Hospital in Columbus, Ohio has successfully treated the first three U.S. patients with the FiberNet® Embolic Protection System during the procedures to place stents in their narrowed carotid arteries. 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® Embolic Protection System is indicated to capture and remove embolic material produced while performing interventional procedures in vessels. Delivery of the FiberNet® 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 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, 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.


Source: Lumen Biomedical

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