Medtronic has launched the TOTAL across crossing catheter, a new peripheral angioplasty balloon technology designed to help improve blood flow in narrowed or occluded lower-extremity arteries, especially in challenging below-the-knee (BTK) vessel bed.
The catheter features a spiral cut stainless steel hypotube construction and 2-French tapered tip designed to help navigate the device through narrow regions.
These features address the specific challenges often encountered in patients with critical limb ischemia (CLI) caused by BTK lesions.
The system has recently received CE Mark approval for sale in Europe and other markets. The company also has submitted an application to the US Food and Drug Administration for clearance (FDA).
The FDA has not yet cleared the TOTAL across crossing catheter or approved any of the IN.PACT drug-eluting balloons.
With 0.014in wire compatibility, the TOTAL across crossing catheter is intended to guide and support a guidewire, including the crossing of a target lesion, during the access of peripheral arteries with obstructive disease and to allow for wire exchanges.
The device is also intended to provide a channel for the infusion of saline solutions or diagnostic contrast agents.
Dr Andrej Schmidt, an angiologist and cardiologist in the Center for Vascular Medicine at Park-Hospital Leipzig in Germany, is among the first European physicians to use the new device.
Dr Schmidt said BTK lesions are a common cause of CLI, which is a particularly difficult condition to treat.
"The TOTAL across crossing catheter represents a tangible step forward in microcatheter design, providing extraordinary support and stability combined with one of the lowest crossing profiles available to better deal with the clinical challenge of distal BTK revascularization," Dr Schmidt said.
Medtronic plans to launch the TOTAL across crossing catheter along with two other devices to treat BTK CLI around the world over the next two years.
Medtronic senior vice-president Tony Semedo said: "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."
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-eluting 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 BTK arteries.
Image: Medtronic world headquarters, Minneapolis, Minnesota, US. Photo: courtesy of Medtronic, Inc.