Published IN.PACT SFA Data Support Medtronic's In.Pact Admiral DCB

December 22, 2014—Medtronic, Inc. announced that the results of IN.PACT SFA I and IN.PACT SFA II, the landmark studies of the company’s In.Pact Admiral drug-coated balloon (DCB), were published by Principal Investigator Gunnar Tepe, MD, et al. The findings are available online ahead of print in Circulation. Prof. Tepe first presented the data in April 2014 at the Charing Cross International Symposium in London.

In this prospective, multicenter, randomized trial, DCB use was superior to percutaneous transluminal angioplasty (PTA) and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral arterial disease (PAD). The data showed that the In.Pact Admiral DCB significantly outperformed standard balloon angioplasty in the treatment of symptomatic PAD in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

According to the company, at 12 months, patients in the study’s DCB group experienced the highest rate of primary patency and the lowest rate of clinically driven target lesion revascularization ever reported from a study of interventional treatments for SFA/PPA disease. 

The investigators concluded that the In.Pact Admiral DCB “stands to become an important treatment option for patients with superficial femoral and popliteal artery disease.” The investigators found that the In.Pact Admiral DCB resulted in superior efficacy when compared to a plain old angioplasty balloon for the treatment of patients with symptomatic SFA/PPA disease. They noted, “There was significantly better primary patency and a marked reduction in the need for target lesion revascularization at 12 months following treatment with the DCB.”

Additionally, the investigators advised that the DCB offered an “attractive alternative” to other treatments for PAD because it “does not limit future treatment options, an important consideration given the chronic and progressive nature of PAD.”

The In.Pact Admiral DCB received European CE Mark approval in 2009, but it is still an investigational medical device in the United States, where it is under review by the US Food and Drug Administration.

According to the company, the IN.PACT SFA trial enrolled 331 patients at 57 sites across Europe and the United States. All study patients were randomized to treatment with the DCB or standard balloon angioplasty. The clinically driven target lesion revascularization rates at 12 months were 2.4% for the DCB group and 20.6% for the PTA group (P < .001), a highly statistically significant difference. Primary patency rates were assessed at 12-month follow-up and showed a highly statistically significant difference: 82.2% for the DCB group and 52.4% for the PTA group (P < .001). The Kaplan-Meier survival estimates for primary patency at day 360 were 89.8% for the DCB group and 66.8% for the PTA group, reported Medtronic.