Medtronic has secured the US Food and Drug Administration (FDA) approval for its IN.PACT AV drug-coated balloon (DCB), a paclitaxel-coated balloon to treat failing arteriovenous (AV) access in patients suffering from end-stage renal disease (ESRD) undergoing dialysis.
AV fistulae are used to facilitate haemodialysis for patients suffering from ESRD. Over time, vessel restenosis restricts the ability to make use of AV fistulae.
To restore function, patients must then undergo one to three maintenance procedures every year, which can lead to disruptions to critical haemodialysis care in addition to increasing costs to the healthcare system.
The randomised trial results from the IN.PACT AV Access trial indicated that IN.PACT AV DCB helps to extend the time between re-interventions by maintaining AV access site patency, maximising a patient’s access to dialysis care.
IN.PACT AV Access trial investigator and Holy Name Medical Center in Teaneck, New Jersey interventional radiologist Vincent Gallo said: “In many cases, AV fistula are considered lifelines for patients with ESRD as they are the primary access point for life-saving dialysis treatment. When these access sites fail, patients experience delays in their dialysis treatment and require multiple re-interventions to keep the site functioning.
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“With this approval physicians now have access to a safe and extremely effective therapy to slow the progression of restenosis, which results in fewer re-interventions and disruptions in care for these patients.”
FDA approval comes from data of a prospective, multicentre, blinded, randomised, global, investigational device exemption (IDE) trial.
The trial, enrolling 330 subjects, evaluated the safety and effectiveness of the IN.PACT AV DCB at 29 locations across the US, Japan and New Zealand.
Early data presented at the Cardiovascular Interventional Radiological Society of Europe (CIRSE) met the primary endpoints in showing the comparable safety and superior effectiveness of IN.PACT AV DCB when compared to percutaneous transluminal angioplasty (PTA).
Compared to patients treated with standard PTA for six months, those treated with IN.PACT AV DCB not only maintained patency longer but also required 56% fewer reinterventions.
The data indicated that mortality rates between the IN.PACT AV DCB group and the PTA control group were not different for 12 months.
The CE Mark indication for IN.PACT Admiral DCB was expanded in 2016 to treat failing arteriovenous (AV) access in patients suffering from end-stage renal disease and undergoing dialysis.