Spectranetics Announces Early Success of EXCITE ISR; Clinical Trial Demonstrated Safety and Efficacy Superiority
Enrollment in Study Concluded; Submitting 510(k) to Food and Drug Administration Today
COLORADO SPRINGS, CO. (March 27, 2014) - The Spectranetics Corporation 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, 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.”
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.
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.
For more information, visit www.spectranetics.com