CLINICAL TRIALS

FiberNet® Clinical Trials


UNITED STATES


EPIC Pivotal Study

Evaluating the Use of the FiberNet Embolic Protection Device in Carotid Artery Stenting

This is a multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients. The primary endpoint of the study is the rate of all death, all stroke, and myocardial infarction within 30 days of the procedure. A number of secondary endpoints will also be evaluated.


The principal investigators for this study are J. Michael Bacharach, MD (Heart Hospital of South Dakota, Sioux Falls, SD) and Subbarao Mylavarapu, MD (Hoag Hospital, Newport Beach, CA).


For more information about the clinical trial contact Lumen Biomedical.


Status: Enrollment Complete


Trial Design: http://www.clinicaltrials.gov/ct/show/NCT00460187


RETRIEVE Feasibility Study

Evaluating the Use of the FiberNet Embolic Protection System in Saphenous Vein Grafts

This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during Saphenous Vein Graft (SVG) intervention.


For more information about the clinical trial contact Lumen Biomedical.


Status: Enrollment Complete


Trial Design: http://www.clinicaltrials.gov/ct/show/NCT0045351


FORTRESS

Sponsored by VIVA Physicians, Inc. FORTRESS is a prospective, single-arm multi-center feasibility trial of renal artery distal protection using the Lumen Biomedical FiberNet® Embolic Protection System in patients with atherosclerotic renal artery stenosis. The study will enroll 20 patients at 5 Clinical Centers.


Status: Enrolling


Trial Design: http://clinicaltrials.gov/ct2/show/NCT00674505


INTERNATIONAL


NET-PV

Novel Embolic Protection Trial - Peripheral Vasculature

The purpose of this study was to evaluate the performance and safety of the FiberNet Embolic Protection System as an adjunctive device in the treatment of carotid and renal artery stenosis. This study enrolled participants under the direction of Professors Antonios Polydorou (Athens, Greece) and Michel Henry (Nancy, France).


Status: Enrollment Complete


Status: Ongoing


Trial Design: http://www.clinicaltrials.gov/ct2/show/NCT00674505

NEWS

May 18, 2009

Volcano Announces Worldwide Exclusive Distribution Agreement With Lumen Biomedical for Xtract(TM) Thrombus Aspiration Catheter

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January 29, 2009

Invatec Announces Worldwide Distribution Agreement with Lumen Biomedical

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November 19, 2008

FDA Approves Lumen Biomedical’s FiberNet Embolic Protection System for Carotid Artery Stenting

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October 22, 2008

Lumen Biomedical Receives FDA Clearance of Embolectomy System for Treatment of Peripheral Artery Disease

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October 16, 2008

FiberNet EPS Clinical Trial Results

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October 3, 2008

Lumen Presence at TCT Conference

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January 1, 2008

Fibernet® Embolic Protection System, Exploring the Differences. Featured Technology, Endovascular Today

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