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Potential Adverse Effects Associated with the IN.PACT AV DCB
Potential adverse effects that may be associated with balloon catheterization may include, but are not limited to, the following:
Although systemic effects are not anticipated, potential adverse effects that may be unique to the Paclitaxel drug coating include, but are not limited to, the following:
The IN.PACT AV drug-coated balloon was evaluated in the IN.PACT AV Access Study. The IN.PACT AV Access Study enrolled 330 patients in the United States, Japan, and New Zealand. The clinical trial conclusively demonstrated safety and effectiveness of the IN.PACT AV DCB when compared to conventional balloon catheters. The results of this study showed that the IN.PACT AV DCB is safe and effective for treating restenotic obstructive lesions of an AV both de novo and restenotic obstructive lesions. Your doctor can explain the risks and benefits that are specific to you.
UC202405894a EN
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