Lutonix® 035 DCB – Dysfunctional AV Fistula Indication
- First and only drug coated balloon approved for use in dysfunctional/stenosed dialysis fistulae
- Shown to enable longer AV fistula function due to increased time to first reintervention compared to standard angioplasty
- 71.4% Primary Patency in the Lutonix® AV Clinical Study at 6 months
- 31.3% fewer reinterventions than PTA at 6 months in the Lutonix® AV Clinical Study
- Demonstrated a safety profile that is as safe as PTA
Lutonix® 035 DCB
After pre-dilatation, Lutonix® 035 DCB is delivered to the target lesion and inflated for a minimum of 2 minutes. During this time, a therapeutic dose of paclitaxel is transferred to the vessel’s endoluminal surface. The balloon is then deflated and removed.
Treatment with the Lutonix® 035 DCB is contraindicated in patients with known hypersensitivity to paclitaxel or paclitaxel-related compounds, and in patients who cannot receive recommended antiplatelet and/or anticoagulant therapy.
NOTE: This procedure overview is not intended as a replacement for the full instructions for use. Please see the IFU for complete preparation and deployment instructions, as well as additional contraindications, warnings and precautions.
Step 1: Pre-Dilatation
Adequately pre-dilate to achieve ≤ 30% residual stenosis prior to DCB use.
Step 2: DCB Transit
Size the DCB so its diameter is ≥ 1:1 to the pre-dilatation balloon. To ensure therapeutic drug delivery, the Lutonix® 035 DCB should be advanced to the target site in the shortest possible time (i.e. ~30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition. If the deployment of Lutonix® 035 DCB exceeds 3 min., the catheter requires replacement with a new unit. Always advance the catheter under negative pressure.
Do not immerse the balloon in a saline bath.
Step 3: DCB Placement
Lutonix® 035 DCB should extend approximately 5 mm proximally and distally beyond the pre-dilatation injury segment. The GeoAlign® Marking System is available on Lutonix® 035 DCB.
Step 4: Balloon Preparation
Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may remain inflated as long as is required by the standard of care to achieve a good angioplasty outcome. Do not exceed the recommended Rated Burst Pressure (RBP) during inflation. The balloon transfers the therapeutic drug dose during this initial inflation.
Step 5: Balloon Removal
Apply negative pressure to fully deflate the Lutonix® 035 DCB. Prior to removal, confirm that the balloon is fully deflated under fluoroscopy. Withdraw the Lutonix® 035 DCB from the body under negative pressure. Maintain the guidewire across the stenosis.
Step 6: Drug Effect
Paclitaxel diffuses into the arterial wall from the endoluminal surface after drug delivery and is designed to decrease the incidence of restenosis and improve patency.
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Please consult Instructions for Use under Resources for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information.
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