Spectranetics Applies for FDA Clearance With Early Success of EXCITE ISR Trial

March 27, 2014—Spectranetics Corporation (Colorado Springs, CO) announced that with the conclusion of enrollment and early success of the EXCITE ISR clinical trial, it is submitting an application to the US Food and Drug Administration (FDA) for 510(k) clearance of the company’s laser atherectomy system used with percutaneous transluminal angioplasty (PTA) in the treatment of in-stent restenosis. In EXCITE ISR, the treatment arm of laser atherectomy plus PTA achieved highly significant statistical superiority in both safety and efficacy compared with the control arm of PTA alone. 

On February 24, the company announced the achievement of statistical endpoints in the EXCITE ISR adjunct analysis.

According to the company, the EXCITE ISR trial was initially designed to enroll a maximum of 318 patients at up to 35 sites. Patients were randomized 2:1, treatment to control. The primary efficacy endpoint is freedom from target lesion revascularization (TLR) through 6 months. The primary safety endpoint is 30-day freedom from major adverse events (all-cause mortality, major amputation in the target limb, or TLR).

Freedom from TLR at 6 months was hypothesized to be 70% in the laser atherectomy plus PTA arm and 53% for the control arm to prove statistical superiority. This benchmark was exceeded after enrollment of 250 patients.

The company noted that this superior outcome was achieved without any borrowing from the PATENT registry, which is a prospective, single-arm feasibility registry that enrolled 90 patients at five sites in Germany. In PATENT, the patients were treated in a manner similar to the control arm of the EXCITE ISR study.

In the Spectranetics press release, EXCITE ISR Primary Investigator Eric J. Dippel, MD, commented, “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 investigational device exemption peripheral study previously conducted.” Dr. Dippel is with the Genesis Medical Center in Davenport, Iowa.