Medical technology company Medtronic has secured approval from the US Food and Drug Administration (FDA) for its IN.PACT AV drug-coated balloon (DCB) to treat arteriovenous (AV) fistula lesions.
IN.PACT AV DCB is a paclitaxel-coated balloon developed to treat failing AV access in patients with end-stage renal disease (ESRD) undergoing dialysis.
The FDA approval was based on data from a prospective, global, multicentre, blinded and randomised (1:1) investigational device exemption (IDE) study.
Medtronic’s trial, which recruited 330 subjects, assessed the safety and effectiveness of the IN.PACT AV DCB at 29 sites in the US, Japan and New Zealand.
According to the company, the pivotal randomised trial results from the IN.PACT AV Access study demonstrated that the DCB can extend the time between reinterventions by maintaining AV access site patency.
IN.PACT AV Access trial investigator Dr 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 reinterventions to keep the site functioning.”
The IN.PACT AV DCB increases blood flow and reduces thickening of the vessel wall by delivering paclitaxel
Leveraging technology from IN.PACT Admiral platform, IN.PACT AV DCB will help increase blood flow and reduce the thickening of the vessel wall by delivering the anti-proliferative drug paclitaxel.
The drug penetrates deep into the vessel wall to avoid prevent restenosis, as well as holds the capacity to extend the time between reinterventions.
In 2016, the company secured expanded CE mark approval for IN.PACT Admiral DCB to treat AV access in patients with end-stage renal disease undergoing dialysis
Medtronic cardiac and vascular group’s peripheral vascular business general manager and vice president Mark Pacyna said: “The FDA approval of IN.PACT AV DCB marks a significant step forward for paclitaxel-coated devices. Importantly, it allows us to expand our proven IN.PACT DCB platform beyond the superficial femoral artery.
“We are excited to bring this technology to physicians in the U.S. and to help improve the lives of patients living with ESRD.”
In October this year, Medtronic introduced the first artificial intelligence (AI) system for colonoscopy.
The GI Genius intelligent endoscopy module is claimed to be the world’s first system that uses AI for the detection of colorectal polyps.
