Business Developments.

Business Developments

Panel says no to new use for CVX-300 laser

The FDA Circulatory System Devices advisory panel early this month grappled with the question of whether a laser alone was as effective in treating patients with blocked arteries as balloon angioplasty and overwhelmingly voted 9-1 against recommending approval of the new indication for Spectranetics (Colorado Springs, Colorado) CVX-300 excimer laser system. Spectranetics presented data on its laser system, which would be marketed as the CliRpath Excimer Laser Catheter as an alternative for patients with a poor prognosis for surgery. The catheters are constructed from multiple fiber optics arranged around a guidewire lumen and intended to recanalize obstructed peripheral vascular arteries. Spectranetics sought approval of the device to salvage limbs in patients with critical limb ischemia who are poor surgical candidates due to occlusions in the superficial femoral artery, popliteal and infrapopliteal arteries, but are acceptable candidates for revascularization.

The company said that the new indication is the result of advances in design and represents the fifth generation of Spectranetics device, first approved by the FDA in 1993 for use in coronary arteries. The laser is very similar to LASIK that is used for refractive surgery in the eye, Chris Reiser, vice president of technology and clinical research at Spectranetics, told the panel. The CVX-300 laser system has been in commercial use in Europe since 1997, Reiser noted. The laser shaves away small layers of tissue about the width of a human hair without …