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Medtronic Recall Raises Red Flag For DCBs Below The Knee

Executive Summary

Drug-coated balloons have emerged as one of the next major product segments within interventional cardiology, particularly for the treatment of peripheral arterial disease, but they appear to have hit their first major bump in the road. In November, Medtronic notified clinicians that it was recalling and discontinuing sales of its In.Pact Amphirion DCB for below-the-knee revascularization in patients with critical limb ischemia, based on forthcoming data from the company’s IN.PACT DEEP clinical study.

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