FDA Approves Expansion of Spectranetics' Clinical Trials

Spectranetics Corp. has won US Food and Drug Administration (FDA) approval for the expansion of the company's peripheral excimer laser angioplasty (PELA) clinical trial sites. The agency doubled the number of US sites allowed from 10 to 20.

Spectranetics' PELA trial is a multinational randomized trial in which patients with a total blockage of at least 10 centimeters in the superficial femoral artery of the leg are treated either with excimer laser treatment in conjunction with balloon therapy, or with balloon therapy alone. The results of the treatments on the two groups are then compared. With the FDA-approved expansion, the study will include 250 patients randomized at 20 sites in the US and at additional sites in Europe. A reference group of 125 non-randomized patients treated using surgery or medication will be tracked at 5 separate sites.

According to Spectranetics, the PELA technology was designed to utilize fiber optics in delivering excimer laser energy in short, precise bursts that dissolve, or ablate, blockages within the artery. The upper leg peripheral market, which is estimated at $300 million annually, is an important future opportunity for Spectranetics, said Joseph A. Largey, company CEO. We believe the expansion of clinical trial sites will further accelerate enrollment rates in the PELA trial.