COLORADO SPRINGS, Colo., May 27, 2015 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced that 12-month data from the EXCITE ISR clinical trial were presented by Craig Walker, MD, at New Cardiovascular Horizons (NCVH) in New Orleans. Results of the landmark study show that Spectranetics' laser atherectomy devices used with PTA (also known as balloon angioplasty), are safer and more effective than PTA alone for treating femoropopliteal (FemPop) in-stent restenosis (ISR), demonstrating continued durability in 12-month results.
Dr. Walker presented the EXCITE ISR 12-month data as part of NCVH's Global Summit on Advanced Aorto-Iliac and Femoral Interventions for Peripheral Artery Disease (PAD) in New Orleans. Critical data findings include:
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Treatment using Turbo-Tandem resulted in significantly less residual stenosis and need for bailout stenting.
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92.9% procedural success rate using Turbo-Tandem with PTA vs. 81.7% with PTA alone (p<0.01).
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Primary safety endpoint, major adverse events (MAEs) rates at 30 days 5.4% vs. 20.8% with PTA alone (p<0.001).
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Primary efficacy endpoint, freedom from target lesion revascularization (TLR) through 6-months 78.3% vs. 58.9% with PTA alone (p=0.002)
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Excimer laser atherectomy with adjunctive PTA was associated with a 43% reduction in TLR through 12-months. (Hazard Ratio 0.57; 95% CI 0.38-0.84; p=0.005).
"This marks a major milestone for patients who suffer from FemPop ISR. EXCITE ISR data shows compelling and durable 12-month clinical results treating incredibly sick patients and sets a new standard of care—one that will change clinical practice," stated Dr. Walker, an EXCITE ISR Primary Investigator and Chairman of NCVH. "Physicians demand proven solutions, and this transformative trial—the only trial of its kind providing Level 1 data—commands attention from the cardiovascular community on behalf of the patients they treat. EXCITE ISR is having a lasting impact on physician protocols while changing lives around the world."
The EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal (arteries above the knee) In-Stent Restenosis (EXCITE ISR) is the first of its kind, large multicenter, prospective randomized trial ever conducted for the treatment of FemPop ISR. In July 2014, Spectranetics received a U.S. Food and Drug Administration (FDA) 510(k) indication of its peripheral atherectomy products, Turbo-Tandem™ and Turbo-Elite™, to treat ISR. Other atherectomy devices are not indicated or contraindicated to treat ISR, uniquely positioning Spectranetics to capitalize on potential market opportunities of $350 million domestically and up to $750 million worldwide.
Implanting stents to open obstructed blood vessels is an important treatment for patients suffering from PAD, a disease that impacts 200 million globally. While stents deliver improved overall outcomes compared to PTA treatment, restenosis (a return of the blockage) is very common, and stent reobstruction or ISR remains therapeutically challenging.
"This year alone, as many as 400,000 patients around the world will receive stent implants to restore the flow of blood due to complications from PAD. An estimated 30% to 40% of those stents will develop restenosis, with a 65% chance of recurrence after treatment with PTA," states Kim Bridges, Senior Vice President of Sales and Marketing, Vascular Intervention, Spectranetics. "This new EXCITE data validates the safety and superiority of laser plus PTA, versus PTA alone, further differentiating our comprehensive portfolio to provide the breadth of cross, prepare and treat solutions that physicians need and patients deserve."
About EXCITE ISR
The EXCITE ISR trial was designed to enroll a maximum of 318 subjects at up to 40 sites, randomized 2:1 treatment to control with predetermined statistical analyses at 200, 250 and 300 enrolled patients. In 2014, Spectranetics announced success of the trial based on achieving highly significant statistical superiority in both safety and efficacy among 252 patients. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone. The primary efficacy endpoint is freedom from TLR through six months. The primary safety endpoint is freedom from MAEs at 30 days. MAEs include all-cause mortality, major amputation in the target limb, or TLR.
About PTA
PTA, also known as balloon angioplasty, is a minimally invasive procedure used to open blocked or stenosed blood vessels. A balloon catheter is placed at the blockage site and inflated to compress the blockage against the vessel wall. While PTA tends to be a temporary solution, it is considered the standard of care for patients with stenosis, a narrowing of the blood vessels in the leg due to PAD, or restenosis, a recurrence of a blockage following treatment. When a stent is used and restenosis occurs, ISR can develop.
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
