Results from the IN.PACT AV Access Study evaluating Medtronic’s (NYSE:MDT) IN.PACT AV drug-coated balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) in patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions met the primary efficacy and safety endpoints. The data were presented at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in Barcelona.
The primary patency (the access site is open and functional) rate at day 180 was 86.1% in the IN.PACT DCB group versus 68.9% in the PTA group (p<0.001). The primary patency rate of the targeted lesion at day 210 was 81.4% for IN.PACT DCM versus 59.0% for PTA (p<0.001).
Patients in the IN.PACT DCB group required 56.0% fewer reinterventions to maintain target lesion patency at day 210 compared to PTA.
On the safety front, the rate of access circuit-related serious adverse events in the IN.PACT DCB cohort was 4.2% versus 4.4% for PTA through day 30.
AV fistulae are AV access sites created by vascular surgeons for short-term use by hemodialysis patients with end-stage renal disease (usually in the neck, chest, or leg in the groin area). Restenosis (abnormal narrowing of the artery or vein) limits the useful life of the access sites which typically require one-to-three maintenance procedures per year in order to restore function.
The device was CE Mark’d in January 2016 for the treatment of failing AV access in patients with end-stage renal disease undergoing dialysis.
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