The In.Pact BTK catheter is slated for an international, randomized pivotal trial that plans to enroll about 400 participants with peripheral artery disease in the lower legs, and who face risks of major amputation or death from chronic limb-threatening ischemia, or CLTI.
The company said it is currently working with regulators to finalize the study design within the next few months.
Medtronic’s In.Pact family of balloon catheters deliver a proprietary formulation of paclitaxel to slow the growth of scar tissue and keep the vessel from reclosing. The FDA has previously approved models for femoral popliteal disease located above the knee, as well as for re-opening lesions in arteriovenous fistulas.
The latter posted positive 12-month clinical results earlier this year, from a post-approval study of patients with end-stage kidney disease receiving dialysis. The In.Pact AV delivered a target lesion primary patency rate of 70.2%, while the patency of the fistula’s access circuit reached 52.6%.
Currently, in the U.S., there are no commercially available drug-coated balloons for the harder-to-reach lesions below the knee. According to Medtronic, uncoated percutaneous transluminal angioplasty, or PTA, serves as the primary treatment for patients with CLTI despite high rates of restenosis and repeated interventions.
Medtronic launched a previous study for In.Pact BTK in 2017. Nine-month feasibility data showed similar safety results compared to PTA, as well as the slower shrinking of arteries over time.
This past July, the FDA approved the latest type of Abbott’s drug-eluting scaffold, with a longer version of the Esprit BTK. The resorbable implant delivers the antiproliferative med everolimus for patients with CLTI.
