Lutonix™ 018 Drug Coated Balloon PTA Catheter | 合法醫療器材資訊網

The Lutonix™ 018 Drug Coated Balloon PTA catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.

The Lutonix™ DCB Catheter is contraindicated for use in:

1) Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy.

2) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

3) Patients judged to have a lesion that prevents complete infl...