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Medtronic on Thursday announced the European launch of its Total Across crossing catheter, angioplasty balloon technology that treats blockages and narrowing of the arteries in the lower extremities.
The Total system also treats blockages in below-the-knee blood vessels, Medtronic said.
Fridley-based Medtronic’s system recently received CE Mark approval for sale in Europe and other markets. The company also has submitted an application to the U.S. Food and Drug Administration for clearance. The FDA has not yet approved the Total Across catheter for sale in the United States.
Dr. Andrej Schmidt, an angiologist and cardiologist at the Center for Vascular Medicine at Park-Hospital Leipzig, Germany, is among the first European physicians to use the device. He called it “a tangible step forward in microcatheter design, providing extraordinary support and stability.”
Tony Semedo, a Medtronic senior vice president and president of its Endovascular Therapies business, said: “The Total Across crossing catheter expands our portfolio of medical devices for the interventional treatment of peripheral artery disease. It's a prime example of our focus on developing lesion-specific solutions and our ongoing commitment to addressing BTK lesions specifically. We are excited to be introducing this new device in Europe and look forward to bringing it to the United States in the near future."
Medtronic said the Total Across crossing catheter is the first of three new products to address below-the-knee critical limb ischemia (CLI) that the company plans to introduce around the world over the next two years. CLI is a severe obstruction of the arteries that decreases blood flow to the arms, hands, legs and feet, progressing to the point of severe pain and even skin ulcers and sores.
Other devices in Medtronic's peripheral product portfolio aimed at treating lower-extremity disease include the Complete SE (self-expanding) vascular stent, the In.Pact line of drug-coated balloons and the Admiral, Pacific and Amphirion families of percutaneous transluminal angioplasty (PTA) balloon catheters. The Pacific and Amphirion PTA balloons are designed specifically for use in below-the-knee arteries, Medtronic said.