Medtronic’s paclitaxel-coated IN.PACT Admiral balloon is being enhanced by a new version called the IN.PACT AV balloon which is being developed in various sizes for the Japanese, NZ and US markets. There are no plans to replace the Admiral device in the EU market.
“Medtronic's IN.PACT AV balloon clinical study yields positive results“
The modified device is designed to facilitate the reopening of collapsing fistulas used by patients as access ports for dialysis treatments, and has met its primary endpoints in its first large study involving 330 patients who had been receiving hemodialysis treatments for an average of 4.3 years. Patients who received treatment with the drug-coated balloon needed 56% fewer reinterventions to maintain their access fistula over 210 days versus traditional percutaneous transluminal angioplasty. The target vessel remained open in 86.1% of treated patients after 180 days, versus 68.9% in the control group. After 210 days, the IN.PACT arm had a patency rate of 81.4%, compared to 68.9% with traditional angioplasty, while safety data were similar.