News | October 16, 2008

EPIC Carotid Stent Trial Reveals Low Stroke Rate

October 16, 2008 - Lumen Biomedical Inc. said that Principal Investigator Subbarao V. Myla, M.D., presented the results from the EPIC clinical trial — “Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting” — at TCT 2008.

From March 2007 to May 2008, the multicenter, single-arm EPIC clinical trial evaluated the FiberNet Embolic Protection System during carotid artery stenting of 237 high surgical risk patients with a critical carotid artery stenosis. The EPIC trial was an FDA IDE clinical study sponsored by Lumen Biomedical Inc.

“EPIC’s superior results stand alone; FiberNet EPS embodies all three successful requirements for safe carotid stenting, low profile, optimal filtration and ease of use,” Dr. Myla said. “The FiberNet System represents the best blend of science and clinical practice finding the right balance of optimal filtration with maintained safe perfusion.”

The FiberNet EPS captures particles released during the carotid artery stenting procedure with a filter made of a 3-dimensional matrix of fibers. The filter is designed to prevent microscopic debris from traveling to the brain. After the particles have been captured, the FiberNet filter is then retrieved into the retrieval catheter, Lumen Biomedical’s FDA-cleared Xtract Aspiration Catheter, and removed from the patient.

The mean age of the patients participating in the clinical trial was 74 years (21 percent were octagenarians), 64 percent male and 20 percent were symptomatic.

Overall, the combined major adverse event rate at 30 days for all death, stroke and myocardial infarction (MI) was 3 percent. There were 5 strokes (4 ischemic and 1 hemorrhagic) for a 30-day stroke rate of 2.1 percent. There were no unanticipated adverse device effects. The results demonstrate that FiberNet EPS' unique features may contribute to a lower stroke rate during carotid artery stenting in high surgical risk patients.

For more information: www.lumenbio.com

Related Content

Boston Scientific Closes Claret Medical Acquisition, Announces Positive Reimbursement Decision
News | Embolic Protection Devices | August 03, 2018
Boston Scientific Corp. announced it has recently closed its acquisition of Claret Medical Inc., a privately-held...
Claret's FDA-cleared Sentinel Cerebral Embolic Protection System for TAVR will expand Boston Scientific's structural heart portfolio. It collects emboli knocked loose that would otherwise lodge in the brain and potentially cause a stroke.

Claret's FDA-cleared Sentinel Cerebral Embolic Protection System for TAVR will expand Boston Scientific's structural heart portfolio. It collects emboli knocked loose that would otherwise lodge in the brain and potentially cause a stroke. 

News | Embolic Protection Devices | July 20, 2018
July 20, 2018 — Boston Scientific Corp.
The Emboliner Embolic Protection Catheteris designed to capture debris released from the valve and vessel walls during transcatheter aortic valve replacement (TAVR) procedures.

The Emboliner Embolic Protection Catheter is designed to capture debris released from the valve and vessel walls during transcatheter aortic valve replacement (TAVR) procedures. It allows for the passage of other catheters during TAVR procedures. 

News | Embolic Protection Devices | June 07, 2018
June 7, 2018 — The first clinical cases have been completed where the Emboliner...
Sentinel Cerebral Protection System Reduces TAVR Strokes More Than 60 Percent
News | Embolic Protection Devices | May 08, 2018
May 8, 2018 — One-year results from the Sentinel Cerebral Protection System show it can reduce the incidence of...
Emboline Inc. Completes Funding for TAVR Embolic Protection Trial
News | Embolic Protection Devices | April 20, 2018
Emerging medical device company Emboline Inc. announced it has completed a Series B funding round totaling over $10...
Sentinel Cerebral Protection System Reaches 50-Center Adoption Milestone in U.S.
News | Embolic Protection Devices | February 19, 2018
Claret Medical announced that since U.S. Food and Drug Administration (FDA) clearance in June 2017, its Sentinel...
The Boston Scientific FilterWire EZ embolic protec filter system.

The Boston Scientific FilterWire EZ embolic protection system.

News | Embolic Protection Devices | October 31, 2017
October 31, 2017 — The VAMPIRE 3 study evaluated if the selective use of distal filter protection might decrease the
Claret Medical Closes $14.5 Million in Series C Financing for Sentinel Cerebral Protection System
News | Embolic Protection Devices | October 23, 2017
October 23, 2017 — Claret Medical announced that it has closed on a Series C financing of $14.5 million led by Lights
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices | September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Protembis Announces Successful First-in-Human Use of  ProtEmbo Cerebral Protection System in European Trial
News | Embolic Protection Devices | September 07, 2017
Protembis GmbH announced the first clinical applications of its ProtEmbo Cerebral Protection System to complement a...
Overlay Init