Spectranetics plans multi-center, randomized clinical trial program for in-stent restenosis

The Spectranetics Corporation (Nasdaq: SPNC) today announced its clinical trial plans related to the treatment of in-stent restenosis (ISR) in arteries above the knee, which remains a major unsolved medical problem. There is no device currently cleared or approved by the FDA to treat ISR.

“I anticipate this important randomized trial will require the enrollment of a large number of patients in a substantial number of centers in the U.S.”

The Company plans to initiate a multi-center, randomized trial in the United States comparing laser ablation followed by adjunctive balloon angioplasty with balloon angioplasty alone.

"Our physician customers prefer randomized, controlled studies to assist them with their clinical decisions surrounding the treatment of in-stent restenosis. Our planned trial will be designed with that in mind, using our recently FDA-cleared above the knee device, the Turbo-Tandem™, as well as our Turbo Elite® laser ablation devices," said Emile J. Geisenheimer, Spectranetics' Chairman of the Board of Directors, President and Chief Executive Officer. "I anticipate this important randomized trial will require the enrollment of a large number of patients in a substantial number of centers in the U.S."

A decision whether to continue enrollments in the PATENT clinical trial, which was originally designed as a feasibility trial, will be made once the FDA has completed their review of the Company's pre-IDE submission for the randomized clinical trial in the U.S. Until then, enrollments will continue in PATENT, which currently has 66 patients enrolled in five centers in Germany. The Company intends to pursue publication of the data from the PATENT trial.

The Company also plans to support a pilot study evaluating the use of laser ablation 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. The planned enrollment for the PHOTOPAC trial is 50 patients, which will be followed for up to one year following the procedure. Spectranetics' support of the PHOTOPAC trial will be in the form of an unrestricted research grant.

Mr. Geisenheimer concluded, "Our clinical trial program for ISR is robust and demonstrates our commitment to evidence-based medicine. We look forward to the results from the trials and will work with the FDA on their approval to begin the randomized trial in the United States as soon as possible."