×

Spectranetics Broadens Laser Catheter Portfolio to Treat Complex Lesions and Chronic Total Occlusions (CTOs)

COLORADO SPRINGS, Colo., Aug. 19, 2013 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced the launch of the Turbo Elite® .035 product line extension. The two new catheter sizes – with diameters of 2.3 mm and 2.5 mm – are compatible with a .035" guidewire, augmenting the versatility of the Turbo Elite laser to treat complex lesions including chronic total occlusions (CTOs) in blood vessels above and below the knee.

The Turbo Elite laser atherectomy catheter was designed specifically for the treatment of Peripheral Artery Disease (PAD), vaporizing blockages in leg vessels and restoring blood flow. The minimally invasive procedure requires less recovery time than bypass surgery and often provides patients with an alternative to amputation.

Vascular surgeon Lawrence J. Goldstein, MD, FACS, participated in clinical evaluations which were conducted at selected regional sites in the U.S. and Europe. He reports consistently saving time and resources when performing crossing procedures with the Turbo Elite system. According to Dr. Goldstein, "I typically attempt to cross an occlusion by first using a .035 guidewire. Because these new catheter sizes are compatible with this wire size, they eliminate the need to change wires to perform the laser atherectomy procedure once I have crossed the lesion."

According to Donna Ford-Serbu, Senior Vice President Global Marketing, Strategy and Portfolio, the Turbo Elite .035 system enables clinicians to cross what is often considered an 'uncrossable' lesion without using a wire. These lesion types are frequently encountered in complex chronic total occlusions, which are reported in up to 40% of patients with peripheral lesions caused by PAD, leaving interventionalists with few treatment options.

"Using a step-by-step lasing technique*, the Turbo Elite .035 can be used to cross a CTO without a guidewire," said Ms. Ford-Serbu. "These new catheters will help fill a need expressed by many interventionalists: more CTO crossing tools. They now have a broader range of versatility that offers safe, proven solutions for patients."

Giancarlo Biamino, MD, Ph.D., Professor of Medicine and Director a.D. of Clinical and Interventional Angiology at the Heart Centre Leipzig in Leipzig, Germany, participated in early physician training on the Turbo Elite .035. A pioneer in the use of laser technology for debulking diseased vessels introducing the step-by-step technique, Dr. Biamino welcomes the addition to the Turbo Elite product line. "One of the biggest concerns in crossing a CTO in the superficial femoral artery is the potential to exit the true lumen and end up in the subintimal space. The Turbo Elite .035 offers a crossing device with true atherectomy and better guidewire support, ensuring effective treatment within the affected lumen of the vessel."

The Turbo Elite .035 represents the latest addition to Spectranetics' CTO solutions portfolio. The company's Quick-Cross® Support Catheter is the world's market leader. Earlier this year, the company introduced the Quick-Access® Needle Holder and Quick-Cross Capture® Guidewire Retriever, completing a portfolio of antegrade and retrograde crossing tools.

Spectranetics will continue to offer extensive physician training events and opportunities throughout 2013 to support procedural success using the new catheters and the other crossing tools that have recently been introduced.

*Lawrence JB, Prevosti LG, Kramer WS, Smith PD, Bonner RF, Lu DY, Leon MB. Pulsed laser and thermal ablation of atherosclerotic plaque: morphometrically defined surface thrombogenicity in studies using an annular perfusion chamber. J Am Coll Cardiol. 1992;19:1091

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 access and treat arterial blockages in the legs and heart, and to remove pacemaker and defibrillator cardiac leads.

The company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee. The company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. In addition, the company markets aspiration and cardiac laser catheters for the treatment of blockages in the heart, and drug delivery catheters for vascular delivery of drugs and diagnostic agents.

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, 2012, 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: The Spectranetics Corporation Karol Norie, Public Relations (719) 447-2463 karol.norie@spnc.comSource:The Spectranetics Corporation