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news.Pathway Medical Technologies has announced that the FDA has given the company clearance to market Jetstream, a peripheral atherectomy catheter designed for use in the treatment of peripheral arterial disease in the lower limbs.
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The clearance is said to mark the company’s second 510(k) clearance and the first device on the market capable of treating an entire spectrum of disease found in the peripheral arterial disease (PAD) patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions with consistent clinical results.
Tom Clement, president and CEO of Pathway Medical, said: “The market introduction of Jetstream represents a major business milestone for our organization and a dramatic new treatment option for the endovascular community in fighting PAD.
“We expect the device to provide interventionalists with the clinical versatility they seek, while providing patients suffering from peripheral arterial disease with more predictable outcomes.”