Enrollment in Study Concluded
Submitting 510(k) to Food and Drug Administration Today
COLORADO SPRINGS, Colo., March 27, 2014 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced early success of the EXCITE ISR clinical trial, achieving highly significant statistical superiority in both safety and efficacy. Notably, this superior outcome was achieved without any borrowing from the PATENT registry. Based on this result, Spectranetics has concluded enrollment in the EXCITE ISR trial and will submit the 510(k) application to the Food and Drug Administration (FDA) today. FDA review of a 510(k) application with clinical data takes an average of five months.
According to Dr. Eric J. Dippel M.D., Genesis Medical Center, Davenport, Iowa, and primary investigator, "EXCITE is a landmark randomized, controlled trial that represents a major step forward in treating patients with in-stent restenosis. Showing a superior safety and efficacy result early and without borrowing from PATENT is compelling. This superior result was achieved in the most challenging lesion cohort relative to any IDE peripheral study previously conducted."
"We are in the process of developing a new, necessary standard of care for ISR patients. Safety and efficacy superiority are the bedrock of our strategy to unlock this $750 million target market," said Spectranetics President and Chief Executive Officer, Scott Drake. "Early success with EXCITE is another critical step toward our goal of accelerating top line growth, expanding gross margins and achieving meaningful operating leverage."
In-stent restenosis (ISR) occurs when a previously placed stent becomes occluded, or blocked, and is considered to be a challenging condition to treat. Spectranetics designed this treatment-to-control trial to show safety and efficacy of treatment with laser atherectomy in patients with ISR. Freedom from target lesion revascularization (TLR) at six months was hypothesized to be 70% in the laser atherectomy plus Percutaneous Transluminal Angioplasty (PTA) arm and 53% for PTA alone to prove statistical superiority. This benchmark was exceeded following enrollment of 250 patients versus the 318 patients originally planned.
About EXCITE ISR
The EXCITE ISR trial was initially designed to enroll a maximum of 318 subjects at up to 35 sites, randomized 2:1 treatment to control. 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 major adverse events (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 PATENT
The PATENT trial is a prospective, single-arm feasability registry and enrolled a total of 90 patients at five sites in Germany. The patients were treated in a manner similar to the control arm of the EXCITE ISR study.
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 over 40 countries and are used to treat arterial blockages in the heart and legs, and 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. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
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