Medtronic's Total Across Crossing Catheter Launched in Europe

February 13, 2014—Medtronic, Inc. (Santa Rosa, CA) announced the European launch of the Total Across crossing catheter, which recently received the CE Mark approval as a tool for improving blood flow through narrowed or occluded lower extremity arteries, including below the knee.

The company advised that it has also submitted an application to the US Food and Drug Administration for 510(k) clearance of device, which is currently under review. The Total Across is not approved for commercial use in the United States, nor are any of Medtronic’s In.Pact drug-eluting balloons. The Total Across crossing catheter is the first of three new products to address BTK critical limb ischemia (CLI) that Medtronic plans to introduce around the world during the next 2 years.

The Total Across crossing catheter is 0.014-inch-wire compatible. It 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 conduit for the infusion of saline solutions or diagnostic contrast agents.

According to Medtronic, the Total Across device features a spiral-cut stainless steel hypotube construction, which provides exceptional pushability and catheter visualization. A 2-F tapered tip allows the catheter to cross lesions smaller than the device profile. These features are designed to address the specific challenges often encountered in patients with CLI caused by BTK lesions.

Andrej Schmidt, MD, from the Center for Vascular Medicine at Park-Hospital Leipzig in Germany, commented in Medtronic’s press release, “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.”