Final Results of Spectranetics Study Supports Successful Use of Laser Atherectomy for Treating Patients With Peripheral In-Stent Restenosis Results Provide Basis for Landmark EXCITE ISR Trial Underway in United States
COLORADO SPRINGS, Colo., Jan. 24, 2013 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced final results from the PATENT (Photo-Ablation using the TURBO-Booster® and Excimer Laser for In-Stent Restenosis Treatment) study evaluating the safety and efficacy of the Spectranetics peripheral laser atherectomy catheters for the treatment of in-stent restenosis (ISR) in the femoropopliteal artery in the leg. ISR occurs as a result of narrowing of the artery in patients who have undergone stenting for the treatment of peripheral arterial disease (PAD). There is currently no FDA-cleared or approved device to treat peripheral in-stent restenosis, which remains a major unsolved medical problem.
Ninety patients participated in this prospective, multi-center registry, which completed enrollment in December 2011 at five centers in Germany. The study evaluated extremely complex patients who had a previously failed stent procedure to address peripheral arterial disease.
Final results presented today by Professor Thomas Zeller (Herz-Zentrum Bad Krozingen, Germany) at the Leipzig Interventional Course (LINC) 2013 in Leipzig, Germany, indicate 82% and 52% freedom from target lesion revascularization (TLR) at six and 12 months, respectively. Laser atherectomy demonstrated excellent midterm primary patency of 64% as compared to 37% with balloon angioplasty primary patency as published in previous clinical registries. This is a significant improvement considering the challenging nature of these patients.
In the PATENT Study, percent diameter stenosis was reduced from 87.1% to 7.5% post-laser atherectomy and balloon angioplasty as measured by the angiographic core lab. Procedural success rate, defined as achievement of ≤ 30% final residual restenosis, was 98.9%, and Cumulative Major Adverse Events (MAEs) were 2.2% from procedure through 30 days following the procedure. Patients saw significant and sustained improvement in ankle brachial index (ABI) and walking ability throughout the study. Laser atherectomy in ISR lesions also preserved excellent stent integrity throughout the duration of the study.
"The PATENT study demonstrates that with laser atherectomy, excellent acute results can be achieved and the underlying stent is not damaged. The patency and TLR rate seem to be significantly better compared to balloon-angioplasty, the current standard treatment of ISR," said Andrej Schmidt of Park Hospital, Leipzig Germany and Principal Investigator for PATENT.
Notably, the freedom from TLR rate within the PATENT study exceeds the targeted rate in the randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis) trial, a landmark study currently underway in the U.S., providing confidence in the EXCITE ISR trial design.
The EXCITE ISR trial will enroll up to 353 patients with chronic PAD associated with femoropopliteal in-stent restenosis at up to 35 centers in the United States. Patients are randomized in a 2:1 allocation to either laser atherectomy with adjunctive balloon angioplasty or balloon angioplasty alone. The study is designed to show superiority of laser atherectomy plus adjunctive balloon angioplasty for the primary efficacy endpoint of freedom from TLR.
"We are very encouraged by the PATENT results. This is a significant step forward in a compelling body of evidence that proves the safety and efficacy of laser atherectomy in treating in-stent restenosis. Successfully treating ISR represents an inflection point in our growth trajectory. This market is more than twice as large as the worldwide atherectomy market," said Scott Drake, CEO of Spectranetics.
The PATENT study population included patients with disease severity ranging from intermittent claudication to critical limb ischemia (Rutherford class 2-5). Lesions ranged from 1cm to 25cm with average total lesion length of 12.3cm, and 93% were in the superficial femoral artery (SFA). Nearly 34% of patients had total occlusions. Fifty percent of patients were diabetics, and 36% had previously been treated for in-stent restenosis using other therapies.
Spectranetics is also supporting a physician-initiated pilot study at four centers in Europe evaluating the use of laser atherectomy followed by a paclitaxel-coated angioplasty balloon (PTX PTA) compared with the use of PTX PTA alone in the treatment of in-stent lesions in above-the-knee arteries. Enrollment of 50 patients is expected to be completed in the first half of 2013. Spectranetics' support of the PHOTOPAC (Photoablation Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in In-stent Femoropopliteal Obstructions) trial is in the form of an unrestricted research grant.
"The midterm patency with laser atherectomy for ISR lesions in the PATENT study is encouraging. We look forward to additional data on the combination of debulking with laser followed by local drug delivery," said Professor Thomas Zeller, a co-Principal Investigator of PHOTOPAC.
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 peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.
The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.
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," and other words and terms of similar meaning in connection with any discussion of, among other things, clinical trials, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property and product development. 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, 2011 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.
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