Lumen Biomedical Receives FDA Clearance Of Embolectomy System For Treatment Of Peripheral Artery Disease

Main Category: Heart Disease
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics
Article Date: 08 Oct 2008 - 8:00 PDT

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Lumen Biomedical, Inc., a Minnesota-based medical device company, announced today receipt of FDA clearance for the LBI Embolectomy System for use in the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

The LBI Embolectomy System consists of a 0.014" guide wire containing a 3-dimensional fiber-based element used in combination with the previously cleared Xtract Aspiration Catheter. The expandable element conforms to the vessel wall while pulling thrombus under aspiration towards the large, single-lumen design of the catheter. System bench testing demonstrated excellent thrombus removal compared to a balloon embolectomy catheter, with the potential for less vessel trauma. The models cleared treat vessel diameters ranging from 3.5 to 7.0 mm.

"Receiving embolectomy clearance is an important milestone for Lumen Biomedical; affirming the belief that our platform of device technology has a potential for broad applications within the human vasculature," commented Matthew Ogle, Chief Executive Officer for Lumen Biomedical.

Peripheral Arterial Disease (PAD) affects 8 to 12 million Americans, and as many as 12-20 percent of those afflicted are age 65 and older. Therefore, novel device innovations increase the options for physicians to aid in these peripheral procedures.

The LBI Embolectomy System is based on the same core technologies used in the company's embolic protection system currently under FDA 510(k) review for carotid use. The EPIC EPS Carotid Trial results will be featured during the Late Breaking Trials Session at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. on October 16th at 1 p.m.

About Lumen Biomedical, Inc. Lumen Biomedical is driven towards the development and commercialization of unique interventional devices for use in multiple anatomical areas where embolic protection or thrombus removal may be required. These markets include peripheral vascular and coronary applications with potentials approaching 1.6 billion worldwide.

Lumen Biomedical, Inc.