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Newly Approved PTA Catheter Launched in US, International Markets
Shortly after receiving FDA clearance and CE mark approval, Medtronic announced the United States and international launch of its Amphirion Plus Percutaneous Transluminal Angioplasty Catheter for the treatment of below-the-knee arteries.
The device, which received CE mark approval in July and FDA 510(k) clearance in June, features an over-the-wire diameter of 0.014 inches and a wide inflation pressure range, reaching 20 atmospheres for all sizes — 2 mm to 4 mm in diameter and through 120 mm in length. The new device also offers fast inflation-deflation to provide an efficient angioplasty solution for “everyday” below-the-knee cases.
The Amphirion Plus Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter joins the Amphirion Deep PTA Balloon Catheter, expanding Medtronic’s product portfolio of medical devices used to treat peripheral artery disease.