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FDA Okays Spectranetics' laser trial extension

This article was originally published in Clinica

Executive Summary

Spectranetics has gained the go-ahead from the US FDA to continue its PELA (peripheral excimer laser angioplasty) trial without the need to randomise half of the patients to a non-laser modality. The PELA III study extension allows the company's CVX-300 excimer laser to be used to treat total occlusions of the upper leg veins, in particular, of those in the main thigh artery at least 10cm long for 120 additional patients, said the Colorado Springs, Colorado firm. "We are able to continue usage of our large 2.2mm and 2.5mm peripheral catheters for PELA III prior to completion and approval of our original PELA trial," Spectranetics' president and CEO Joseph Largey said. The product already has FDA clearance for use in the cardiovascular setting and the company expects the FDA to approve the device in 2003 for use in non-cardiovascular applications.

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