Medtronic’s In.Pact BTK DCB Earns FDA Breakthrough Device Designation

October 1, 2026—Medtronic announced it has received Breakthrough Device designation from the FDA for its In.Pact below-the-knee (BTK) paclitaxel drug-coated balloon catheter, which is an investigational technology currently in development.

According to Medtronic, the In.Pact BTK device is built on the In.Pact platform with the company’s FreePac paclitaxel coating, which has demonstrated sustained safety and effectiveness in femoropopliteal disease through 5 years in randomized clinical studies.

Medtronic is planning the global, randomized IN.PACT BTK DELTA pivotal study that will evaluate the safety and effectiveness of the investigational In.Pact BTK device. The trial will enroll approximately 400 patients with BTK lesions. The company advised it is working closely with regulators and investigators to finalize the study design in the coming months.

Eric Secemsky, MD, will serve as the Global Principal Investigator for the IN.PACT BTK DELTA trial. Dr. Secemsky is an interventional cardiologist with Beth Israel Deaconess Medical Center in Boston, Massachusetts.

“Finding effective therapies for chronic limb-threatening ischemia patients with lesions below the knee is one of the most pressing unmet clinical needs in contemporary endovascular therapy,” commented Dr. Secemsky in Medtronic’s press release. “The IN.PACT BTK DELTA clinical trial is an important opportunity to find a better treatment option for these at-need patients.”