Medtronic has announced the European launch of a new peripheral angioplasty balloon, TOTAL across that targets challenging lesions in the lower-extremity, including below-the-knee arteries associated with critical limb ischaemia.
TOTAL across recently received the CE mark as a tool for improving blood flow through narrowed or occluded lower-extremity arteries, including those below the knee.
With 0.014-inch 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 2Fr tapered tip. The spiral cut stainless steel hypotube construction affords exceptional pushability and unparalleled catheter visualisation, 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 ischaemia caused by lesions below the knee.
A press release from Medtronic also says the company has submitted an application to the US 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.
The TOTAL across crossing catheter is the first of three new products to address the clinical challenge of critical limb ischaemia below the knee that Medtronic plans to introduce around the world over the next two years, the press release notes.