Medtronic announced the US and international launches of the Amphirion Plus Percutaneous Transluminal Angioplasty (PTA) Catheter for the interventional treatment of atherosclerotically narrowed leg arteries below the knee.
The Amphirion Plus PTA Catheter is designed to treat peripheral arterial disease. With an over-the-wire diameter of 0.014 inches, it joins the Amphirion Deep PTA Balloon Catheter, which targets lesions in arteries below the ankle.
Physicians in Europe and the United States have started to use the new device, which recently received the CE mark and 510(k) clearance by the FDA.
“The Amphirion Plus Balloon features outstanding pushability and crossability characteristics and exceptional inflation-deflation performance,” said Nezar Falluji, an interventional cardiologist at St Joseph Cardiology Associates in Lexington, USA, who performed the first case with the new device worldwide. “Its innovative design has made the Amphirion family of PTA balloons excellent tools in the management of critical limb ischaemia and below-the-knee intervention.”
Another early user of the new device, Marco G Manzi, chief of the interventional radiology unit at Policlinico Abano Terme in Vincenza, Italy, added: “With the Amphirion Plus Balloon, even the most challenging calcified below-the-knee arteries can become more accessible.”
Distinguishing features of the Amphirion Plus PTA Balloon Catheter include the device’s wide inflation pressure range, which reaches 20 atmospheres (rated burst pressure) for all sizes –– from 2.0mm to 4.0mm in diameter and through 120mm in length.