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Wed, May 12, 2010

Spectranetics Introduces First Advanced System for Simulation of Laser Assisted Lead Extractions


Published on 2010-05-12 04:11:30 - Market Wire
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DENVER--([ BUSINESS WIRE ])--HEART RHYTHM 2010 a" [ Spectranetics Corporation ] (NASDAQ:SPNC) today announced it will showcase a new advanced Laser Lead Extraction Simulation system at the Heart Rhythm Societya™s (HRS) 31st Annual Scientific Sessions, [ Heart Rhythm 2010 ]. The new simulation system is intended to augment traditional procedural training for physicians on laser-assisted lead extraction procedures by permitting hands-on practice with extraction tools and techniques in multiple case scenarios in a virtual operating environment.

"Of all the procedures I do, lead extraction has the steepest and longest learning curve. Many studies have now demonstrated that in experienced hands extraction is a safe and effective approach to lead management"

Due in part to the large and growing number of leads to manage in patients implanted with pacemakers and defibrillators, in May 2009 HRS updated its expert consensus recommendations for lead extraction. Acknowledging the challenge for physicians to achieve the desired volume of proctored cases in a training regime, HRS experts highlighted lead extraction simulation with realistic scenarios as an important future component of initial hands-on exposure and subsequent maintenance of skills. One year later, Spectranetics is demonstrating its continuing commitment to training, education, and patient outcomes by delivering a solution toward the objectives outlined by HRS.

Spectranetics has partnered with Medical Simulation Corporation (MSC) to develop the customized Laser Lead Extraction Simulation in conjunction with MSCa™s SimSuite® simulation technology platform. The simulation system features simulated patient scenarios that allow physicians to manipulate lead extraction tools with tactile feedback and visual diagnostics such as avirtuala x-ray imagery that closely mimics real-world patient scenarios. Physicians are able to experience the force interactions coinciding with successful techniques and encounter potential complications to learn avoidance and management skills. The simulation system specifically incorporates use of the Spectranetics SLS® II Laser Sheath, LLD EZ® Lead Locking Device and VisiSheath® Dilator Sheath in the lead extraction process.

"Of all the procedures I do, lead extraction has the steepest and longest learning curve. Many studies have now demonstrated that in experienced hands extraction is a safe and effective approach to lead management," said Dr. Laurence Epstein, Chief of Cardiac Arrhythmia Services at Brigham and Womena™s Hospital. "Unfortunately the ability for physicians to receive robust training is limited. The old approach of asee one, do one, teach onea™ does not provide the experience experts feel is important, therefore the availability of a realistic simulator is a major step forward in physician training and thereby improved patient outcomes."

Leads, or insulated wires that connect devices to the heart, may become non-functional or infected resulting in the need for removal. As scar tissue can bind the leads in several places along their length, removing cardiac leads can be challenging and requires proper training in extraction techniques and management of potential complications. Spectranetics provides its excimer laser sheath technology to vaporize the binding scar tissue, thereby freeing the leads for removal.

aAs an increasing number of patients are implanted with cardiac devices, there is a growing need for experienced physicians to manage the issues that arise with the leads in these systems,a said Emile J. Geisenheimer, Chairman, President and Chief Executive Officer of Spectranetics. aThe Laser Lead Extraction Simulation system further demonstrates our commitment to providing physicians with tools to assist them in achieving safe and effective patient outcomes and making high-quality lead extraction therapy available to the millions of patients who need access.a

The Laser Lead Extraction Simulation system, along with Spectraneticsa™ Lead Management solutions, can be viewedat Booth 1613 at Heart Rhythm 2010 Exhibit, which is taking place May 13-15, 2010 at the Colorado Convention Center in Denver, Colorado. Simulation opportunities for physicians will become available this summer through a variety of educational forums.

About Spectranetics

[ Spectranetics ] develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Companya™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 [ www.spectranetics.com ].

About Medical Simulation Corporation

Medical Simulation Corporation (MSC) is the recognized healthcare industry leader in providing full-service simulation training and education services to healthcare personnel, medical societies and medical product manufacturers. MSCa™s patient safety solutions are designed to strengthen the competence and confidence of nurses, physicians and technologists. Through its network of training platforms, MSC can provide customized training services to any location worldwide. For more information, please visit [ www.medsimulation.com ] or call 888/889-5882.

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. These risks and uncertainties may include adverse results of the securities litigation or the stockholder derivative litigation in which the Company or any of its officers or directors is a party, insufficient insurance coverage or the denial of insurance coverage related to legal costs or any settlement or judgment in connection with those proceedings, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which, among other things, affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital and has rendered our investments in auction rate securities illiquid, market acceptance of excimer laser atherectomy technology, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, adverse outcome of FDA inspections, the receipt of FDA approval to market new products or applications, and the timeliness of any approvals, market acceptance of new products or applications, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with the Companya™s relocation and consolidation of its manufacturing operations, and price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. 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.

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