February 18, 2014 — Medtronic Inc. launched in Europe its Total across crossing catheter. Total received CE marking 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 product. 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.
Total is compatible with 0.014-inch wire. 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. It can also allow for wire exchanges. The device is also intended to provide a conduit for the infusion of saline solutions or diagnostic contrast agents.
Total across crossing catheter features a spiral cut stainless steel hypotube construction and 2-French tapered tip. The spiral cut stainless steel hypotube construction affords pushability and 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.
The Total across crossing catheter is the first of three products to address the clinical challenge of BTK CLI that Medtronic plans to introduce around the world over the next two years.
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.
For more information: www.medtronic.com