
Clinical evidence
IN.PACT™ AV drug-coated balloon
A clinical review of IN.PACT™ AV drug-coated balloon (DCB) and other therapies for AV fistula maintenance.
IN.PACT™ AV DCB:
IN.PACT™ AV DCB treats the cause of restenosis — not just the symptoms — helping to move your patients in the right direction.
See six-month outcomes from separate AV access maintenance trials evaluating PTA balloons, stents, and DCBs.†
† Target lesion primary patency in an AV fistula IDE randomized controlled trial.
‡ Primary patency rates are defined differently. Results are from different studies and may vary in a head-to-head comparison; charts are for illustration purposes only.
Compared to PTA, the IN.PACT AV drug-coated balloon is the first and only DCB to show both superior and sustained results at 36 months in treating AV fistula lesions.
Results from separate trials comparing drug-coated balloons to standard PTA for AV fistula maintenance.
† Target lesion primary patency in an AV fistula IDE randomized controlled trial.
‡ Primary patency rates are defined differently. Results are from different studies and may vary in a head-to-head comparison; charts are for illustration purposes only.
§ IN.PACT™ AV Access Trial: Target lesion primary patency rate was defined as freedom from clinically driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 36 months (1,080 days) post-procedure.
◊ Lutonix™ AV Clinical Trial: Target lesion primary patency was defined as freedom from clinically driven reintervention of the target lesion or access thrombosis measured through 24 months.
¶ IN.PACT™ AV Access Trial: Access circuit primary patency was defined as freedom from reintervention in the access circuit or access circuit thrombosis measured through 36 months (1,080 days) post-procedure.
# Lutonix™ AV Clinical Trial: Access circuit primary patency was defined as freedom from access circuit revascularization or access circuit thrombosis measured through 24 months.
This product is licenced with Health Canada as "IN.PACT AV PACLITAXEL-COATED PTA BALLOON CATHETER" on Health Canada licence number "MDL#104501".
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