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Press Release Source: Spectranetics Corporation
Spectranetics Receives 510(k) Clearance for Laser Technology to Treat Total Occlusions in Leg Arteries
Thursday April 29, 10:45 am ET
Company Plans to Launch CLiRpath(TM) Product Line Immediately
COLORADO SPRINGS, Colo., April 29 /PRNewswire-FirstCall/ -- Spectranetics Corporation (Nasdaq: SPNC - News) today announced it has received market clearance from the U.S. Food and Drug Administration (FDA) to treat patients suffering from total occlusions (blockages) in their leg arteries with Spectranetics' proprietary excimer laser catheters.
The market clearance, which was supported by clinical data from a subset of patients enrolled in the LACI (Laser Angioplasty for Critical limb Ischemia) trial, applies to most of the company's coronary catheters ranging in diameter from 0.9 millimeters to 2.0 millimeters in addition to new 2.2 and 2.5 millimeter diameter catheters specifically designed for treating blockages in the peripheral vasculature.
Professor Giancarlo Biamino, Director of the Department of Clinical and Interventional Angiology at the University of Leipzig Heart Center, and a pioneer in laser-assisted endovascular intervention for peripheral vascular disease, commented, "It is an ethical must to treat patients with symptomatic ischemic peripheral vascular disease using aggressive endovascular revascularization procedures. The excimer laser is an essential tool to recanalize total occlusions and remove obstructive material to transform diffuse disease into more easily ballooned stenoses. Clinical studies with the excimer laser demonstrate that this approach results in excellent limb salvage rates with a low risk of distal embolization. We have been using the excimer laser to treat complex peripheral vascular disease in Europe with excellent results for over a decade."
"We are delighted with the favorable response from FDA to our 510(k) application, and look forward to bringing this important new treatment option to certain patients suffering from critical limb ischemia, a debilitating condition," said John G. Schulte, Spectranetics' president and chief executive officer.
"Patients with total occlusions refractory to guidewire have so few treatment options that surgery -- either bypass or amputation -- is nearly inevitable," he added. "Our research indicates that approximately 1.5 to 2 million people in the U.S. and Europe suffer from critical limb ischemia, and that more than 200,000 patients may benefit from laser treatment. We plan to immediately launch the CLiRpath product line to our customers who already have a laser and an active interventional peripheral program. We will solicit an initial stocking order of four to six catheters in these 100 accounts and plan to complete this phase of our launch within 90 days. We will update our financial guidance sometime after the initial 90-day period when we have a better view of re-order rates."
About Critical Limb Ischemia and the LACI Trial
Critical Limb Ischemia (CLI) is associated with multi-level arterial disease between the thigh and the ankle, and is dominated by occlusions (total blockages) rather than stenoses (partial blockages). The extent and location of the disease often make arterial reconstruction, including surgery and balloon angioplasty, difficult.
The Spectranetics 510(k) submission contained clinical data obtained from a subset of the LACI trial, and was supplemented by data obtained from other similar clinical studies in the U.S. and Europe. In those studies, the 47 patients treated were poor surgical candidates and were not amenable to other minimally invasive percutaneous procedures, such as balloon angioplasty, since the lesions were not crossable with a guidewire. Limb salvage was observed in 95% of patients surviving for six months with no increase in serious adverse events as compared with other patients in the LACI study.
About Spectranetics
Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Our CVX-300® excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including peripheral atherectomy of total occlusions not crossable with a guidewire, coronary atherectomy, the treatment of in-stent restenosis prior to radiation therapy, and the removal of problematic pacemaker and defibrillator leads. Nearly all of our FDA-approved and investigational applications have received Communautes Europeennes (CE) mark registration for marketing within Europe.
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 increasing price and product competition, increased pressure on expense levels resulting from expanded marketing 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, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, the potential size of market opportunities associated with new products, market acceptance of new products or applications, product defects, 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.
Spectranetics and CVX-300 are registered trademarks of The Spectranetics Corporation.
For further information, please contact John Schulte, Chief Executive Officer, or Guy Childs, Chief Financial Officer, both of Spectranetics Corporation, +1-719-633-8333; or Investors & Media, Bruce Voss, or Ina McGuinness, both of Lippert/Heilshorn & Associates, Inc., +1-310-691-7100, for Spectranetics Corporation.
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Source: Spectranetics Corporationg |
