FDA clears Pathway's peripheral catheter for thrombectomy

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Pathway Medical Technologies, a developer of endovascular treatments for peripheral arterial disease (PAD), has received extended FDA 510(k) clearance to market its peripheral atherectomy catheter, Jetstream G2, for clearing thrombus from the upper and lower extremity peripheral arteries.

The Kirkland, Wash.-based company said its Jetstream G2 is capable of treating the spectrum of disease found in patients suffering from PAD, including calcified and non-calcified plaque, calcium, fibrotic lesions and thrombus, with consistent results.

Jetstream G2 was initially cleared by the FDA in January to remove artery-clogging plaque in the lower limbs of patients, Pathway said. The peripheral atherectomy catheter consists of a sterile, single-use catheter and control pod and a reusable console that mounts to a IV stand.