COLORADO SPRINGS, Colo., Dec. 8, 2015 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (NASDAQ: SPNC ) today announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) submission of the Bridge Occlusion Balloon. Building on the long-standing clinical success and proven procedural safety of cardiac lead extraction, the Bridge Occlusion Balloon is designed to dramatically reduce blood loss in the rare event of a tear in the superior vena cava (SVC) during a lead extraction procedure, providing a "bridge" to surgical intervention.
The Bridge Occlusion Balloon deploys in less than one minute, conforming to the vessel, stemming blood flow and providing acceptable occlusion for at least 30 minutes. The device is designed to give the physician adequate time to safely transition the patient for surgical repair and to give the surgeon the benefit of a clear field of view for the repair procedure.
"Upon a clearance to enter the U.S. market, the Bridge Occlusion Balloon will be the most significant innovation in lead management since the laser was introduced by Spectranetics 20 years ago," said Jude Clancy, MD, Electrophysiologist, Assistant Professor of Medicine and Director, Lead Management Program at Yale Medical Group, New Haven, Conn. "The device can add the critical element of time to minimally invasive lead removal protocols and help alleviate an extracting physician's primary concern of gaining control during an SVC tear. The device provides physicians a sense of confidence so more indicated patients can have their leads removed safely."
"Spectranetics is committed to safe, predictable and responsible lead management that saves lives and improves quality of life for patients. Our FDA submission advances our commitment to innovation and safety in cardiac lead removal," said Donna Ford-Serbu, Senior Vice President of Sales and Marketing, Lead Management, Spectranetics. "Even though SVC tears during minimally invasive lead removal are rare, occurring in less than 0.5% of procedures, we aim for zero mortalities."
About Lead Management
There are more than 7 million pacemakers and implantable cardiac defibrillators (ICDs) implanted worldwide, 700,000 new devices implanted each year and 1.5 million new leads implanted annually. These devices and the leads that connect them to the heart need ongoing management and maintenance. Sometimes this includes removal due to lead damage, lead or device infection, or manufacturer advisory. Laser lead extraction has been a treatment option for more than 20 years. Multiple studies show a procedural success rate of more than 97% demonstrating safety, effectiveness and efficiency of laser lead removal. In 2014, Spectranetics introduced mechanical tools into its comprehensive portfolio of lead management solutions.
About Spectranetics
SPNC develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are sold in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator 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 AngioSculpt® scoring balloon used in both peripheral and coronary procedures and Stellarex™ drug-coated balloon peripheral angioplasty platform, which received European CE mark approval in December 2014. 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. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
The Lead Management product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and 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 and the Private Securities Litigation Reform Act of 1995. You can identify these statements because they do not relate strictly to historical or current facts. Such statements may include words such as "anticipate," "will," "estimate," "expect," "look forward," "strive," "project," "intend," "should," "would," "plan," "believe," "hope," "enable," "potential," "aim" and other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, clinical trials, regulatory or competitive environments, our intellectual property and product development. These forward-looking statements include, but are not limited to, statements regarding our competitive position, product development and commercialization schedule, expectation of continued growth and the reasons for that growth, growth rates, strength, integration and product launches, and 2015 outlook including projected revenue and expenses, net loss and gross margin. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements and to note they speak only as of the date of this release. These risks and uncertainties may include financial results differing from guidance, inability to successfully integrate AngioScore and Stellarex into our business, market acceptance of excimer laser atherectomy technology and our vascular intervention and lead removal products, lack of cash necessary to satisfy our cash obligations under our outstanding 2.625% Convertible Senior Notes due 2034, our debt adversely affecting our financial health and preventing us from fulfilling our debt service and other obligations, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of our strategic direction, dependence on new product development, loss of key personnel, uncertain success of or delays in our clinical trials, adverse results in any ongoing legal proceeding, or any legal proceeding in which we may become involved, adverse impact to our business of the health care reform and related legislation or regulations, including changes in reimbursements, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital, 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 any planned improvements to our manufacturing processes, and share 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 our actual results, performance or achievements to materially differ from any anticipated results, performance or achievements, please see our previously filed SEC reports, including those risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2014, and our Quarterly Report on Form 10-Q for the three months ended September 30, 2015. We disclaim any intention or obligation to update or revise any financial or other projections or other forward-looking statements, whether because of new information, future events or otherwise.
Investor Relations Contacts Guy Childs (719) 447-2415 Lynn Pieper (415) 202-5678
