Lumen Biomedical Receives FDA Clearance for Peripheral Artery Disease Embolectomy System


October 9, 2008

October 9, 2008 - Lumen Biomedical Inc. said today the FDA cleared 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-inch guide wire containing a three-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 mm.

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.

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