With a focus on developing lesion specific solutions for peripheral artery disease, Medtronic, Inc. has announced the U.S. and international launches of the Amphirion Plus Percutaneous Transluminal Angioplasty (PTA) Catheter for the interventional treatment of atherosclerotically narrowed or occluded leg arteries below the knee.
With risk factors including a history of smoking, poor diet and lack of exercise (similar to those for other forms cardiovascular disease), peripheral artery disease affects more than 100 million people worldwide, including an estimated 10 million people in the United States, according to the Vascular Disease Foundation. Its clinical impact on health varies by anatomical location.
Peripheral artery disease below the knee often causes critical limb ischemia, in which poor blood circulation in the calf, ankle, foot and toes can lead to ulcerated sores, amputation and premature death. Epidemiological research indicates that 50 percent of patients who undergo amputation due to peripheral artery disease die within five years.
“The Amphirion Plus Balloon features outstanding pushability and crossability characteristics and exceptional inflation-deflation performance,” said Nezar Falluji, M.D., an interventional cardiologist at St. Joseph Cardiology Associates in Lexington, Ky., 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 ischemia and below-the-knee intervention.”
Another early user of the new device, Marco G. Manzi, M.D., chief of the interventional radiology unit at Policlinico Abano Terme in Vicenza, Italy, added: “With the Amphirion Plus Balloon, even the most challenging calcified below-the-knee arteries can become more accessible.”
Amphirion Plus has received the CE mark and 510(k) clearance by the U.S. Food and Drug Administration (FDA).