Medtronic Receives FDA Breakthrough Device Designation for IN.PACT BTK Drug-Coated Balloon
Medtronic has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its IN.PACT BTK Paclitaxel Drug-Coated Balloon Catheter, an investigational technology currently in development. The designation is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions, with the FDA providing timely interaction and communication throughout device development and regulatory review.
Peripheral arterial disease (PAD) below the knee represents one of the highest-risk patient groups in the peripheral vascular space, with patients at high risk for major amputation and death. The most advanced stage of PAD, chronic limb-threatening ischemia (CLTI), frequently involves below-the-knee arteries and is particularly common among patients with comorbidities such as diabetes and chronic kidney disease. Drug-coated balloons are widely used to treat PAD in arteries above the knee and have demonstrated improved vessel patency compared with conventional balloon angioplasty. However, because there is currently no commercially available drug-coated balloon indicated for PAD treatment below the knee in the U.S., uncoated percutaneous transluminal angioplasty remains the primary endovascular treatment option for many CLTI patients despite high rates of restenosis and repeat intervention.
Eric Secemsky, MD, interventional cardiologist with Beth Israel Deaconess Medical Center, who will serve as the global principal investigator for the planned trial, said finding effective therapies for CLTI patients with lesions below the knee is one of the most pressing unmet clinical needs in contemporary endovascular therapy. Secemsky noted that the IN.PACT BTK DELTA clinical trial is an important opportunity to find a better treatment option for these patients.
To advance evidence-based treatment options for patients with CLTI, Medtronic is planning IN.PACT BTK DELTA, a global, randomized pivotal study of approximately 400 patients with below-the-knee lesions. The trial will evaluate the safety and effectiveness of the investigational IN.PACT BTK device, and the company is working closely with regulators and investigators to finalize the study design in the coming months.
The investigational IN.PACT BTK device is built on the IN.PACT platform with the proprietary FreePac paclitaxel coating, which has demonstrated sustained safety and effectiveness in femoropopliteal disease through five years in randomized clinical studies. David Moeller, Senior Vice President and President of Medtronic Peripheral Vascular Health, said the planned trial reflects the company’s confidence in the safety and effectiveness of paclitaxel drug-coated balloons. Moeller noted that Medtronic looks forward to generating rigorous clinical evidence to find better solutions for patients facing one of the most serious forms of PAD.
