Healthcare Industry News: Ablation Catheter
News Release - July 15, 2009
Spectranetics Announces First Human Uses of Turbo-Tandem System
COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--Spectranetics Corporation (Nasdaq: SPNC ) today reported the first human procedures using its Turbo-Tandem™ System, which had earlier received FDA clearance and CE mark approval for marketing in the US and the EU. The Turbo-Tandem System is a single-use, disposable device indicated for atherectomy of infrainguinal arteries. It is comprised of two integrated catheters, a 7 French laser guide catheter in combination with a 2.0mm excimer laser Ablation Catheter, and is designed to perform atherectomy and ablation of plaque in arterial lesions above the knee, primarily within the superficial femoral and popliteal arteries.The first procedure in the EU took place on July 6th at Park-Krankenhaus Leipzig-Sudost GmbH in Leipzig, Germany and was performed by Dr. med. Matthias Ulrich in collaboration with Professor Dr. med. Dierk Scheinert. A 23 cm restenotic obstruction in the proximal superficial femoral artery was treated with a Spectranetics Turbo Elite® 2.0mm excimer laser catheter to create a pilot channel through the occlusion, followed by four passes of the Turbo-Tandem to atherectomize the two separate target treatment segments. After completion of the laser atherectomy and adjunct angioplasty, distal runoff was excellent with brisk TIMI 3 blood flow and no evidence of embolic impact. Following the procedure, Dr. Ulrich and Professor Scheinert commented: "The newly integrated Turbo-Tandem device allowed us to easily direct the laser catheter tip and deliver the laser energy accurately at the complex plaque burden. In comparison to the previous version of this catheter, the Turbo-Booster®, the set-up time was fast, the device was easier to manage, and the luminal gain exceeded our expectations. Overall, we are very satisfied with the performance of the Turbo-Tandem System."
The Turbo-Tandem was introduced to the US market with two procedures on July 8th and 9th which were presented to the attendees and faculty at the New Cardiovascular Horizons (NCVH) conference in New Orleans. The first case was performed by Professor Scheinert and was televised live via satellite from Leipzig, Germany. The second case, which was the first Turbo-Tandem case in the United States, was performed by Dr. Craig M. Walker, Founder and Medical Director of the Cardiovascular Institute of the South at Houma, LA and was also televised live to the NCVH conference. Dr. Walker treated a 95% discrete proximal lesion in the superficial femoral artery, debulking and atherectomizing the lesion utilizing four quadrant passes followed by circumferential passes. Post-treatment, angiography confirmed a sizable luminal gain, with excellent distal runoff and no evidence of embolic impact. After the procedure, Dr. Walker stated, "I have had extensive experience with the Spectranetics Turbo-Booster® to treat disease in the superficial femoral and politeal arteries, and the Turbo-Tandem is a significant improvement to the original design. It is a lower-profile 7 French system, is very easy to use, and I encountered no slippage of the catheter as I maneuvered it through the stenotic segments of the artery. This is a very useful device for ablating plaque in the large arteries above the knee."
Emile J. Geisenheimer, Chairman, President and Chief Executive Officer of Spectranetics commented, “I am pleased with the results of the first human procedures involving the Turbo-Tandem product as well as the additional eight live cases involving our Turbo elite laser catheters that were observed by the faculty and attendees of the NCVH conference. At our recently concluded meeting with our entire U.S. sales organization, I observed significant enthusiasm and support for the Turbo-Tandem system and the related product launch plans, which will commence immediately. I look forward to the results of their sales activities and feedback from our physician customers on the performance of this important product.”
About Spectranetics
Spectranetics manufactures and markets the only Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. More than 800 Spectranetics laser systems are used in hospitals worldwide.
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 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 pacemaker and defibrillator cardiac leads.
For more information visit www.spectranetics.com.
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 FDA and Immigration and Customs Enforcement investigation, 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 Company’s relocation and consolidation of its headquarters and 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.
Source: Spectranetics
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