December 4, 2013
Medtronic Recalls In.Pact Amphirion DEB for Below-the-Knee Disease Based on Trial Results
December 4, 2013—Based on forthcoming data from the IN.PACT DEEP clinical study, Medtronic, Inc. (Minneapolis, MN) has recalled and stopped selling its In.Pact Amphirion drug-eluting balloon (DEB) for below-the-knee (BTK) revascularization in patients with critical limb ischemia. The company confirmed that other devices in the In.Pact DEB product family are not subject to this recall. Specifically, the In.Pact Admiral and Pacific DEBs (for use in the superficial femoral artery [SFA]) and the In.Pact Falcon DEB (for use in coronary arteries) remain commercially available in markets where they have been approved.
In a notification sent to customers in early November, Medtronic stated that after 12 months of follow-up in the IN.PACT DEEP study, there was no difference found between the In.Pact Amphirion DEB treatment group and the standard balloon angioplasty control group in any of the study's three primary outcome measures. The study also identified a potential safety signal with a trend toward an increased rate of major amputations in the DEB study arm.
The customer communication further stated that "causality between major amputation and use of the In.Pact Amphirion DEB could not be established or excluded. Subset and multivariate analyses of the data have not revealed any specific cause, and no other evidence from the trial has explained this finding."
The IN.PACT DEEP study was a postmarket, multicenter, randomized controlled trial to determine the safety and efficacy of treatment with the In.Pact Amphirion DEB for BTK revascularization in patients with critical limb ischemia. Prespecified primary efficacy endpoints included clinically driven target lesion revascularization (TLR) and late lumen loss. The primary safety endpoint was a composite of all-cause death, major amputation, or TLR. The study randomized 358 patients (2:1) to treatment with either the In.Pact Amphirion DEB or standard balloon angioplasty.
The first presentation of the study’s findings will occur at the Leipzig Interventional Course (LINC 2014) that is to be held January 28–31 in Leipzig, Germany.
Medtronic noted that all IN.PACT DEEP study patients will continue to be followed per protocol for up to 5 years to better understand the longer-term outcomes. The company hopes that this continued study will help to elucidate the cause of the signals seen and then determine how to best move forward with BTK DEB therapy.
Additionally, the company states that it remains committed to the treatment of BTK disease. In the next year, Medtronic plans to launch a new microcatheter that is specifically designed for crossing difficult BTK lesions and will continue development of other products to advance the treatment of BTK disease.
Medtronic will present the results of the IN.PACT SFA I and IN.PACT SFA II clinical studies at the Charing Cross International Symposium to be held in London, April 5–8, 2014. Data from these two randomized controlled trials will support the company’s premarket approval application to the US Food and Drug Administration for the In.Pact Admiral DEB to treat SFA disease.
In its customer communication, the company noted that it does not believe that the IN.PACT DEEP study outcomes carry any predictive value with regard to other DEB trials studying other anatomic districts. Multiple investigations (including six published studies) evaluating DEB use in the SFA have shown positive and consistent outcomes with respect to patency, TLR, and adverse events. The large differences between BTK and SFA disease—including greater PAD severity, presence of wounds, and smaller vessel diameters—may be a potential cause of the very different outcomes seen, stated Medtronic.