Printer Friendly

Spectranetics Receives FDA Approval for Site Change Related to Manufacturing of CVX-300[R] Laser System.

COLORADO SPRINGS, Colo. -- Spectranetics Corporation (Nasdaq: SPNC) today announced that the Food and Drug Administration (FDA) has approved the Company's premarket approval application (PMA) supplement requesting a manufacturing site change for the CVX-300[R] laser system. The move of laser system manufacturing from its current location in Colorado Springs, Colorado is part of a broader plan to consolidate all product manufacturing into a single, more efficiently designed facility following rapid expansion of the Company's business within the last five years, a period in which revenue has nearly tripled. The employees involved in the manufacturing of laser systems will move to the new manufacturing site, which is also located in Colorado Springs and further serves as corporate headquarters.

The process leading to this approval involved the submission of extensive documentation supporting the site change and an inspection of the Company's facility by FDA personnel. Obtaining this approval expands Spectranetics' manufacturing capabilities at corporate headquarters after completing the transfer of 510(k) products in 2009.

The Company expects to submit a separate PMA supplement to the FDA later this year requesting a manufacturing site change for its remaining products, the ELCA[R] coronary atherectomy product line and the SLS[R] II laser-assisted lead extraction product line.

Shar Matin, Senior Vice President of Operations, Product Development and International, stated, "Completion of the manufacturing site change for our laser system is one of several key initiatives targeted at improving our operating efficiencies throughout the Company. We are pleased to have completed this effort, including a successful FDA inspection, and look forward to completing the consolidation of all product manufacturing, including the ELCA and SLS II products, by the end of this year."

About Spectranetics

Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are sold in 40 countries throughout the world and are used to treat arterial blockages in the heart and legs as well as the removal of problematic pacemaker and defibrillator leads.

The Company's Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.

The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of problematic pacemaker and defibrillator cardiac leads.

For more information, visit

Safe Harbor Statement

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.
COPYRIGHT 2011 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2011 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1U8CO
Date:Jan 20, 2011
Previous Article:RealD Introduces XLW Cinema System for 3D Projection in Premium Large Screen Venues.
Next Article:Wendy's/Arby's Group Exploring Strategic Alternatives for Arby's.

Terms of use | Copyright © 2018 Farlex, Inc. | Feedback | For webmasters