Medtronic launches TOTAL Across Crossing Catheter in Europe and submits an application to the FDA for 510(k) clearance.
Minneapolis - Medtronic Inc. has initiated the European launch of the TOTAL across crossing catheter, a medical device that recently received the CE (Conformité Européene) mark as a tool for improving blood flow through narrowed or occluded lower-extremity arteries, including those in the especially challenging below-the-knee (BTK) vessel bed.
The company has also submitted an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the new product that is currently under review. The FDA has not yet cleared the TOTAL across crossing catheter or approved any of the IN.PACT drug-eluting balloons. The TOTAL across crossing catheter is not approved for commercial use in the United States.
With 0.014" 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 conduit for the infusion of saline solutions or diagnostic contrast agents.
Distinguishing features of the TOTAL across crossing catheter include the device's spiral cut stainless steel hypotube construction and 2-French tapered tip. The spiral cut stainless steel hypotube construction affords exceptional pushability and unparalleled catheter visualization, while the tapered tip allows the catheter to cross lesions smaller than the device profile. These features address the specific challenges often encountered in patients with critical limb ischemia (CLI) caused by BTK lesions.
"BTK lesions are a common cause of CLI, which is a particularly difficult condition to treat," explained Andrej Schmidt, MD, an angiologist and cardiologist in the Center for Vascular Medicine at Park-Hospital Leipzig in Germany. "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 is among the first European physicians to use the new device.
"The TOTAL across crossing catheter expands our portfolio of medical devices for the interventional treatment of peripheral artery disease," said Tony Semedo, a senior vice president at Medtronic and president of the company's Endovascular Therapies business. "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."
The TOTAL across crossing catheter is the first of three new products to address the clinical challenge of BTK CLI that Medtronic plans to introduce around the world over the next two years.