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FDA approves peripheral stent system for patients with PAD
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The FDA announced that it has approved a peripheral stent system to treat patients with narrowing of a superficial femoral or proximal popliteal artery due to atherosclerosis.
The peripheral stent system (Misago, Terumo Medical) consists of a nitinol stent mounted within a delivery catheter, according to a release from the agency.
The stent is deployed after balloon angioplasty and increases blood flow to the leg by holding the artery wall open, according to the release.
According to the agency, it should not be used in patients with lesions that prevent complete inflation of the angioplasty balloon or proper placement of the stent or delivery system, patients with severe blood clots in the blood vessel or lesion before or after angioplasty, patients taking blood thinners such as aspirin or warfarin and patients allergic to nickel and titanium.
According to FDA documentation, the approval was made on the basis of the results of the OSPREY study, in which 99.2% of patients were free from major adverse events 30 days after the procedure, and 78.9% were free of patency loss at 12 months.