Study Links Paclitaxel To Lower-Leg Amputations
New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.
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Research investigating outcomes in patients treated with paclitaxel-coated devices demonstrated a consistent if modest mortality signal when compared to bare-metal stents. However, the signal was not seen in real-world data, and some researchers question whether the signal might stem from problems in the original trials.
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.
The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.