Market-Leading Quick-Cross(R) Support Catheter Receives Regulatory and Reimbursement Approval
COLORADO SPRINGS, Colo., Jan. 29, 2013 (GLOBE NEWSWIRE) -- The Spectranetics Corporation today announced regulatory and reimbursement approval by Japan's Ministry of Health, Labour and Welfare (MHLW) for its Quick-Cross® Support Catheter for peripheral interventions. This approval enables a limited launch in targeted hospitals, followed by full launch later in 2013. Other products in the family, the Quick-Cross Extreme, Quick-Cross Select and additional product sizes have been or will be submitted for MHLW review later this year.
The Quick-Cross family of support catheters was FDA-approved in 2004 -- the first guidewire support catheter to receive FDA approval – and is the recognized market leader in the United States. The device is used to direct and support a guidewire access to vasculature during interventional treatment of peripheral artery disease (PAD) and Critical Limb Ischemia (CLI). The Quick-Cross' low-profile tapered tip eases the crossing of complex and challenging lesions, tracking effectively through the twists and bends of the peripheral vasculature. Crossing total occlusions requires robust guidewire support, and Quick-Cross is the first choice of many physicians for these complex lesions.
PAD is a condition that causes blood vessels, predominantly in the legs, to become restricted or blocked. Left untreated, it can ultimately result in non-healing wounds on the legs and feet, gangrene and even amputation. Smoking and diabetes are primary contributors to the incidence of PAD and CLI. Disease prevalence combined with Japan's healthcare system makes this one of the most attractive markets in the world.
Spectranetics currently distributes SLS® II Laser Sheaths, LLD® Lead Locking Devices, and ELCA® Coronary Laser Atherectomy Catheters in Japan. The approval of Quick-Cross represents Spectranetics' first step into the peripheral intervention market. With its Japanese distributor partner DVx, Inc., Spectranetics continues to expand market access to its broader portfolio of Vascular Intervention and Lead Management products.
"We've had tremendous growth in Japan with our lead management and coronary atherectomy product lines. Entering peripheral artery disease with Quick-Cross in the world's second largest medical device market is a key element of our global expansion strategy," stated Scott Drake, CEO of Spectranetics.
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 more than 40 countries and are used to treat arterial blockages in the heart and legs, as well as the removal of 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 pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
Safe Harbor Statement
This news release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934 (the Exchange Act), as amended, and the Private Securities Litigation Reform Act of 1995, and is subject to the safe harbor created by that section. Forward-looking statements contained in this release constitute our expectations or forecasts of future events as of the date this release was issued and are not statements of historical fact. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Such statements may include words such as "anticipate," "will," "estimate," "expect," "project," "intend," "should," "plan," "believe," "hope," "enable," "potential," and other words and terms of similar meaning in connection with any discussion of, among other things, clinical trials, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property and product development. You are cautioned not to place undue reliance on these forward-looking statements and to note that they speak only as of the date hereof. Factors that could cause actual results to differ materially from those set forth in the forward-looking statements are set forth in the risk factors listed from time to time in our filings with the SEC. Readers are encouraged to review Item 1A. - Risk Factors and all other disclosures appearing in the Spectranetics Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission, for further information on risks and uncertainties that could affect Spectranetics' business, financial condition and results of operation. We disclaim any intention or obligation to update or revise any financial projections or forward-looking statements due to new information or other events.
CONTACT: COMPANY CONTACTS
The Spectranetics Corporation
Karen Hackstaff, Public Relations
(719) 602-9365
karen.hackstaff@spnc.com
INVESTOR CONTACT
Westwicke Partners
Lynn Pieper
(415) 202-5678
lynn.pieper@westwicke.com
