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Kidney conditions

Chronic kidney disease

Learn about chronic kidney disease (CKD), how to manage it, and how to treat it.

Important Safety InformationIN.PACT AV drug-coated balloonPotential Adverse Effects Associated with the IN.PACT AV DCBPotential adverse effects that may be associated with balloon catheterization may include, but are not limited to, the following:

Abrupt vessel closure

Allergic reaction

Arrhythmias

Arterial or venous aneurysm

Arterial or venous thrombosis

Death

Dissection

Embolization

Hematoma

Hemorrhage

Hypotension/hypertension

Ischemia or infarction of tissue/organ

Infection

Loss of permanent access

Pain

Perforation or rupture of the artery or vein

Pseudoaneurysm

Restenosis of the dilated vessel

Shock

Stroke

Vessel spasms or recoil

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:

Allergic/immunologic reaction

Alopecia

Anemia

Gastrointestinal symptoms

Hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia)

Hepatic enzyme changes

Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis

Myalgia/arthralgia

Myelosuppression

Peripheral neuropathy

IN.PACT AV: Summary of Clinical InformationThe 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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