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X Technologies gets FDA nod for pivotal trial:

This article was originally published in Clinica

Executive Summary

The US FDA has given X Technologies the go-ahead to begin a pivotal clinical study of its FX miniRAIL coronary dilatation catheter. The device, which will be assessed at nine centres in the US and Europe, is a low profile, 6F compatible system that integrates two flexible stainless steel wires adjacent to the dilatation balloon. These wires focus the balloon's dilatation force to create two longitudinal expansion planes in the coronary plaque and stabilise the balloon across the target lesion. The Tustin, California firm is currently launching the product in Europe.

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