endovascular.es

Título: First Randomized Trial of the Stellarex™ Drug-coated Balloon Presented at the Amputation Prevention Symposium
Fecha: 10-08-2016
COLORADO SPRINGS, Colo., Aug. 10, 2016 (GLOBE NEWSWIRE) -- The Spectranetics Corporation(NASDAQ:SPNC) today announced that Professor Marianne Brodmann of Medical University Graz, Austria, presented the final 12-month results of the Stellarex Drug-coated Balloon ILLUMENATE European Randomized Clinical Trial (EU RCT) at the Amputation Prevention Symposium (AMP) in Chicago, Illinois. The EU RCT Trial enrolled 328 patients, 295 of whom were randomized to treatment with the Stellarex drug-coated balloon (DCB) or a percutaneous transluminal angioplasty (PTA). The key results at day 365 include:
- Primary patency, per Kaplan-Meier survival estimates, was 89.0% for the DCB group and 65.0% for the PTA group. Primary patency means a restoration of adequate blood flow through the treated segment of the diseased artery.
- Freedom from clinically-driven target lesion revascularization (CD-TLR), per Kaplan-Meier survival estimates, was 94.8% for the DCB group and 85.3% for the PTA group. Freedom from CD-TLR is a measure of repeat procedures due to loss of adequate blood flow and recurrent symptoms related to the treated lesion.
Dr. Henrik Schöder, the trial’s National Principal Investigator from Jewish Hospital in Berlin, Germany, said, “The Stellarex DCB produced outstanding results in this rigorous trial, validating its earlier First-in-Human and interim ILLUMENATE Global studies. These consistent, high quality outcomes are achieved with a low dose drug balloon, making this device especially compelling. Physicians now have a powerful tool to prevent restenosis and improve their patients’ quality of life.”
The EU RCT Study was conducted with the highest level of rigor to ensure accuracy and reliability of the data. Independent, blinded third parties included a clinical events committee and angiographic and duplex ultrasound core laboratories to assess diagnostic images and outcomes.
“While results clearly show a highly significant gain compared to PTA, they favorably match the highest rates of primary patency with a low drug dose,” said Professor Brodmann. “It is very encouraging for us physicians to observe such a tremendous evolution in DCB technologies and appreciate how low-dose and highly stable coatings such as Stellarex can achieve and beat such high clinical performance benchmarks while offering excellent deliverability and tractability.”
Scott Drake, President and CEO, stated, “Spectranetics is committed to leading the way in clinical science to provide patients and customers with proven treatment algorithms. We are pleased that the Stellarex DCB achieved top-tier results in its first randomized trial, and value our customer and key opinion leader feedback that Stellarex is a next generation device.”
The Stellarex DCB is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease. Spectranetics launched the device in Europe in January 2015, with U.S. commercialization anticipated in the 2017 timeframe.
About the Stellarex Drug-coated Balloon Platform
The Stellarex drug-coated balloon (DCB) platform is designed to treat peripheral arterial disease. The Stellarex DCB uses EnduraCoat™ technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. The Stellarex DCB platform received CE mark to be marketed in the European Union in December 2014. It is not for sale in the United States. Spectranetics looks forward to releasing additional analysis on the Stellarex DCB later this year.
About the ILLUMENATE Clinical Program
There are five clinical studies evaluating the safety and efficacy of the Stellarex DCB platform and support United States and Canadian regulatory filings. There are four ILLUMENATE clinical studies in addition to the ILLUMENATE EU RCT Trial described above:
- The ILLUMENATE First-In-Human (FIH) Study was a non-randomized, multi-center study that enrolled 80 patients. In the pre-dilatation arm (n=50), the primary patency rate at was 89.5% at 12 months and 80.3% at 24 months.
- The ILLUMENATE Pharmacokinetic Study measured the Paclitaxel drug levels in the blood of 25 patients enrolled at two sites.
- The ILLUMENATE Pivotal Study is a prospective, randomized controlled, multi-center trial with 300 patients enrolled at 43 sites to support U.S. FDA approval. Results are expected to be released later this year.
- The ILLUMENATE Global study is a prospective, multi-center, single-arm study with 371 patients enrolled. Interim data on the first 220 subjects showed a primary patency rate of 86.5% at 12 months. Final data are expected to be released in early 2017.
About Spectranetics
The Spectranetics Corporation develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are available 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 the 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 presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, 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 and regulatory approvals, regulatory or competitive environments, outcome of litigation, 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 2016 outlook and projected results 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 presentation. These risks and uncertainties may include financial results differing from guidance, increasing competition and consolidation in our industry, the impact of rapid technological change, slower revenue growth and losses, inability to successfully integrate AngioScore and Stellarex into our business and the inaccuracy of our assumptions regarding AngioScore and Stellarex, market acceptance of our technology and products, our inability to manage growth, 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 and successful commercialization of new products, loss of key personnel, uncertain success of or delays in our clinical trials, costs of and adverse results in any ongoing or future legal proceedings, adverse impact to our business of healthcare reform and related legislation and regulations, including changes in reimbursements, adverse conditions in the general domestic and global economic markets and volatility and disruption of the credit markets, our inability to protect our intellectual property and intellectual property claims of third parties, availability of inventory and components from suppliers, adverse outcome of FDA inspections, including FDA warning letters and any remediation efforts, the receipt of FDA clearance and other regulatory approvals to market new products or applications and the timeliness of any clearance and approvals, product defects or recalls and product liability claims, cybersecurity breaches, ability to manufacture sufficient volumes to fulfill customer demand, our dependence on third party vendors, suppliers, consultants and physicians, unexpected delays or costs associated with any planned improvements to our manufacturing processes, risks associated with international operations, lack of cash necessary to satisfy our cash obligations under our outstanding 2.625% Convertible Senior Notes due 2034 and our term loan and revolving loan facilities, our debt adversely affecting our financial health and preventing us from fulfilling our debt service and other obligations, 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 2015 Annual Report on Form 10-K and our Quarterly Report on Form 10-Q for the three months ended June 30, 2016. 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

Zach Stassen
Sr. Director of Finance
zach.stassen@spnc.com
(719) 447-2292

Michaella Gallina
Director of Investor Relations
michaella.gallina@spnc.com
(719) 447-2417
Fuente: endovascular.es

endovasculares.es