FDA clears Pathway peripheral atherectomy catheter
Pathway Medical Technologies, an endovascular treatments company for peripheral arterial disease (PAD), was granted FDA clearance to market Jetstream, a peripheral atherectomy catheter designed for use in the treatment of PAD in the lower limbs.
The clearance marks the company's second 510(k) clearance and the first device on the market capable of treating an entire spectrum of disease found in PAD, including hard and soft plaque, calcium, thrombus and fibrotic lesions with consistent clinical results, according to Kirkland, Wash.-based Pathway.
The company said its Jetstream represents a minimally invasive solution to clear blockages in the peripheral vasculature, restoring blood flow and effectively treating PAD. Jetstream consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard IV stand. The catheter has an expandable cutting tip with rotating blades that safely debulk and preemptively remove both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions, Pathway said.
The clearance marks the company's second 510(k) clearance and the first device on the market capable of treating an entire spectrum of disease found in PAD, including hard and soft plaque, calcium, thrombus and fibrotic lesions with consistent clinical results, according to Kirkland, Wash.-based Pathway.
The company said its Jetstream represents a minimally invasive solution to clear blockages in the peripheral vasculature, restoring blood flow and effectively treating PAD. Jetstream consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard IV stand. The catheter has an expandable cutting tip with rotating blades that safely debulk and preemptively remove both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions, Pathway said.