Medtronic received FDA approval for its IN.PACT Admiral drug-coated balloon for treatment of peripheral artery disease in the superficial femoral and popliteal arteries of the upper leg. As the balloon is inflated it emits paclitaxel, an antiproliferative medication, to prevent scar tissue from forming around the treatment site and blocking the artery anew. The device has been cleared in Europe since 2009 and has already been used in approximately 100,000 patients.
The IN.PACT Admiral has proven effective in maintaining patency of the arterial lumen after one year in a trial when compared with traditional percutaneous transluminal angioplasty. The reduced cases of restenosis will help prevent repeat procedures to re-open up the vessels and aid in maintaining a healthy lifestyle for those receiving the treatment.
Some details on the clinical data that led to the approval according to Medtronic:
The DCB arm of the IN.PACT SFA Trial demonstrated the lowest clinically-driven target lesion revascularization (CD-TLR) rate ever reported for an interventional treatment of PAD in the superficial femoral artery (SFA), with only 2.4 percent of patients treated with the IN.PACT Admiral DCB requiring a repeat procedure at one year, compared to one in five patients (20.6%) treated with percutaneous transluminal angioplasty (PTA).
The data also revealed the highest reported rates of primary patency, which measures sustained restoration of adequate blood flow through the treated segment of the artery. Based on Kaplan-Meier survival estimates for primary patency at 360 days, the data showed an 89.8 percent sustained restoration of blood flow in the DCB group compared to 66.8 percent for the PTA group. Using the trial’s protocol definition, primary patency assessed at 12 months of follow up was 82.2 percent for the DCB group and 52.4 percent for the PTA group.
The exceptionally positive clinical data from the pivotal IN.PACT SFA Trial, which compared treatment with the IN.PACT Admiral DCB to standard balloon angioplasty, has been approved by the FDA without the use of an independent advisory panel.