Lutonix® 035 DCB – Dysfunctional AV Fistula Indication 



Features:


  • 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

 

Paclitaxel: Inhibits Cell Division Plus Inhibits Cell Growth Equals Inhibits Intimal Hyperplasia

Lutonix® 035 DCB

LUTONIX® 035 DCB

Treated Vessel

Treated Vessel

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.

1 After pre-dilating the stenotic lesion in the dysfunctional fistula, the DCB should be centered across the entire treated area
2 Two minute minimum inflation transfers therapeutic dose of the drug to the vessel wall
3 Paclitaxel inhibits restenosis in the vessel by inhibiting smooth muscle cell proliferation and migration, preventing neointimal hyperplasia formation
4 Lutonix® 035 DCB extends complication-free survival by lengthening the time to restenosis and improving fistula function

Download PDF

 

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.

Download PDF

 

 

 

Product Number Diameter Length Catheter Length French Size RBP
LX3540540V 5 40 40 cm 5F 12
LX3540560V 5 60 40 cm 5F 12
LX3540580V 5 80 40 cm 5F 12
LX35405100V 5 100 40 cm 5F 12
LX3540640V 6 40 40 cm 5F 12
LX3540660V 6 60 40 cm 5F 12
LX3540680V 6 80 40 cm 5F 12
LX35406100V 6 100 40 cm 5F 12
LX3540740V 7 40 40 cm 5F 12
LX3540760V 7 60 40 cm 5F 12
LX3540840V 8 40 40 cm 7F 12
LX3540860V 8 60 40 cm 7F 12
LX3575440V 4 40 75 cm 5F 12
LX3575460V 4 60 75 cm 5F 12
LX3575480V 4 80 75 cm 5F 12
LX35754100V 4 100 75 cm 5F 12
LX3575540V 5 40 75 cm 5F 12
LX3575560V 5 60 75 cm 5F 12
LX3575580V 5 80 75 cm 5F 12
LX35755100V 5 100 75 cm 5F 12
LX3575640V 6 40 75 cm 5F 12
LX3575660V 6 60 75 cm 5F 12
LX3575680V 6 80 75 cm 5F 12
LX35756100V 6 100 75 cm 5F 12
LX3575740V 7 40 75 cm 5F 12
LX3575760V 7 60 75 cm 5F 12
LX3575840V 8 40 75 cm 7F 12
LX3575860V 8 60 75 cm 7F 12
LX3575940V 9 40 75 cm 7F 11
LX3575960V 9 60 75 cm 7F 11
LX35751040V 10 40 75 cm 8F 11
LX35751060V 10 60 75 cm 8F 11
LX35751240V 12 40 75 cm 9F 10
LX35100840V 8 40 100 cm 7F 12
LX35100860V 8 60 100 cm 7F 12
LX35100940V 9 40 100 cm 7F 11
LX35100960V 9 60 100 cm 7F 11
LX351001040V 10 40 100 cm 8F 11
LX351001060V 10 60 100 cm 8F 11
LX351001240V 12 40 100 cm 9F 10

Please consult Instructions for Use under Resources for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information.

For ORDERING INFORMATION, please call Customer Service: (800) 321-4254

Some documents on this site are stored in Adobe® PDF format and require Adobe® Reader® to view. Click here to download.

TOP