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news.Pathway Medical Technologies, a manufacturer of medical devices for the treatment of arterial disease, has announced that the FDA has granted the company 510(k) clearance to market its new Jetstream G2 peripheral atherectomy catheter for use in the treatment of peripheral artery disease in the lower limbs.
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Jetstream is a peripheral atherectomy catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients.
According to Pathway, Jetstream G2 is capable of treating the entire spectrum of disease found in the peripheral artery disease (PAD) patient, including hard and soft plaque, calcium, thrombus and fibrotic lesions, with consistent results.
With simple set up and an ergonomic design for easy operation by trained clinicians, Jetstream G2 maximizes treatment effectiveness with an average device activation time of about three and a half minutes during atherectomy treatment. Jetstream offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications, the company said.
Paul Buckman, president and CEO of Pathway Medical Technologies, said: Jetstream G2 is a major milestone for the company and the industry, and we firmly believe that this enhanced technology will significantly increase the number of PAD sufferers for whom atherectomy is a viable treatment option.