Pathway nets CE Mark for peripheral atherectomy catheter

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The European Union has granted CE Mark approval for Pathway Medical’s Jetstream G2 NXT System, a peripheral atherectomy catheter used in the treatment of peripheral artery disease (PAD).

According to the Kirkland, Wash.-based company, the Jetstream system has a single-use catheter and reusable console that mounts to an IV stand. In addition, the instrument is a minimally invasive solution used in the removal of blockages and artery-clogging plaque in the lower limbs of PAD patients.

The Jetstream G2 NXT was granted 501(k) clearance by the FDA in August. The CE Mark now permits the distribution of the device throughout all of the 27 European member states.