Spectranetics Receives FDA 510(k) Clearance for Larger Diameter AngioSculpt(R) Scoring Balloon Enabling Entry Into New Markets
Unlocks niche in endovascular care with $150M market opportunity;
Enables physicians to deliver precision, power, safety for hemodialysis fistula or graft
COLORADO SPRINGS, Colo., June 24, 2015 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced it has received U.S. Food and Drug Administration 510(k) clearance for the AngioSculpt® PTA Scoring Balloon Catheter in 7 and 8 millimeter (mm) diameter balloon sizes. The products are ideally suited to treat the narrowing of the native or synthetic fistula, a surgically created conduit between an artery and vein used to remove and return blood during hemodialysis.
Approximately half of all patients who undergo balloon angioplasty will return with recurrent hemodialysis access dysfunction within six months1. The AngioSculpt PTA Scoring Balloon Catheter in 7 and 8 mm diameter assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty.
“In spite of advances in medical device technology, maintaining hemodialysis access function remains a difficult challenge,” stated George Mueller, MD, Bethesda Hospital in Boynton Beach, Florida. “The AngioSculpt Scoring Balloon Catheter, now in sizes appropriate for a larger range of vessel diameters, has the potential to address the most difficult problems we encounter in treating AV access dysfunction. The product provides the power physicians need, partnered with a controlled dilatation that reduces dissection rates and trauma to the vessel. Physicians who frequently treat these patients are hopeful that adoption of the new tool will demonstrate that it not only preserves, but extends the life of an access.”
In addition to the hemodialysis access market, the AngioSculpt Scoring Balloon Catheter in 7 and 8 mm diameter is also appropriately sized to prepare highly calcified lesions in the iliac and superficial femoral arteries. These lesions traditionally challenge routine stent placement. Due to the product’s lower inflation pressures, the larger diameter AngioSculpt provides a safe approach to preparing the vessel for optimal stent placement.
“This is a large market with ample opportunity to improve patient outcomes with superior technology, combining precision, power and safety,” states Kim Bridges, Senior Vice President of Sales and Marketing, Vascular Intervention, Spectranetics. “The 7 and 8 mm AngioSculpt expands the AngioSculpt product line, the number one specialty balloon in the market, and extends Spectranetics’ comprehensive portfolio to cross, prepare and treat the most complex cardiovascular conditions, now to include hemodialysis access.”
1. Vasa. 2010 May;39(2):133-9. doi: 10.1024/0301-1526/a000018.
About AngioSculpt Scoring Balloon Catheters
AngioSculpt Scoring Balloon Catheters represent the next generation in angioplasty balloon catheters to treat both coronary and peripheral artery disease. Their innovative nitinol scoring elements provide unique circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while minimizing “geographic miss” through their unique anti-slip properties. AngioSculpt Scoring Balloon Catheters combine the versatility and effectiveness of a new technology with the simplicity and deliverability of traditional high-performance balloon catheters.
AngioSculpt devices have been used in over 350,000 procedures worldwide, achieving an outstanding performance record in the treatment of both coronary and peripheral artery disease.
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 (LM) 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,” “plan,” “believe,” “hope,” “enable,” “potential,” 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 2014 Annual Report on Form 10-K. 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.
CONTACT: COMPANY CONTACT The Spectranetics Corporation Guy Childs, Chief Financial Officer (719) 633-8333 INVESTOR CONTACT Westwicke Partners Lynn Pieper (415) 202-5678 lynn.pieper@westwicke.com Help employers find you! Check out all the jobs and post your resume.
