COLORADO SPRINGS, Colo., May 6, 2013 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced the Food and Drug Administration's (FDA) approval of its adjunct analysis plan associated with the EXCITE ISR clinical trial, studying the treatment of in-stent restenosis (ISR) in the legs. The goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon angioplasty (PTA) compared with PTA alone, prior to full enrollment of the EXCITE ISR study.
Spectranetics' adjunct analysis plan incorporates multiple interim data analyses of patients enrolled in the ongoing EXCITE ISR trial, with the potential to leverage data from the recently completed PATENT trial. The plan allows for six-month follow-up to be completed in a subset of patients.
The primary endpoints of the EXCITE ISR trial, freedom from target lesion revascularization (TLR) through 6 months and freedom from major adverse events (MAEs) at 30 days, remain unchanged. MAE includes all-cause mortality, major amputation in the target limb, or TLR.
"We are pleased to have achieved this meaningful step toward FDA approval of our therapy to treat in-stent restenosis," said Scott Drake, President and Chief Executive Officer. "The adjunct analysis provides a potentially streamlined path for improving patients' lives and capitalizing on this transformative global market opportunity, which we estimate at 250,000 procedures annually. We continue to target mid-2014 for commercialization of the ISR indication. Our commitment to prove clinical superiority over PTA treatment alone in ISR patients is steadfast. Today, we are focused on completion of the EXCITE ISR trial and, in the future, we believe our ongoing PHOTOPAC study will show that laser atherectomy combined with drug-coated balloons is a next generation ISR treatment."
"The approval of the adjunct analysis underscores the need for proven technologies to treat patients with in-stent restenosis. Today, these patients are largely treated using PTA alone with suboptimal clinical outcomes. No device on the market has the ISR indication and successful completion of the EXCITE ISR trial will address a large, unmet clinical need for more durable outcomes in this difficult patient population," stated Dr. Eric Dippel, lead physician investigator for EXCITE ISR.
About EXCITE ISR
The EXCITE ISR trial will enroll a maximum of 318 subjects at up to 35 sites, randomized 2:1 to treatment or control. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone. The primary efficacy endpoint is freedom TLR through 6 months. The primary safety endpoint is freedom from MAE at 30 days. MAE includes all-cause mortality, major amputation in the target limb, or TLR.
About PATENT
The PATENT trial is a prospective, single-arm registry and enrolled a total of 90 patients at five sites in Germany. The patient population was similar to the EXCITE ISR study and the patients were treated in a manner similar to the control arm of the EXCITE ISR study. Results of the PATENT study were presented at LINC 2013 in Leipzig Germany and included 82% freedom from TLR at six months follow-up and a 2.2% MAE rate through 30 days post-procedure.
About PHOTOPAC
The PHOTOPAC study is a physician-sponsored, randomized, multi-center study conducted in Germany, comparing laser atherectomy plus drug-coated balloon to drug-coated balloon alone in patients with complex in-stent restenosis. The PHOTOPAC study was recently expanded from 50 patients to 125 patients. Spectranetics supports the study in the form of an unrestricted research grant.
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 treat arterial blockages in the heart and legs, as well as 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 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," "target" and other words and terms of similar meaning in connection with any discussion of, among other things, statements about the Company's expectations regarding its clinical trials and approvals from the FDA. 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.