IN.PACT AV (vascular balloon)

History

2022: Withdrawal of defective balloon catheters due to sterility problems

On March 31, 2022, Medtronic announced the voluntary recall of part of its In.Pact Admiral and In.Pact AV balloon catheters. The company initiated the recall of balloon catheters for paclitaxel-coated transdermal transluminal angioplasty due to the possibility of pocket damage resulting in loss of sterility.

According to Medtronic, the recall affected approximately 6 thousand In.Pact Admiral catheters and three In.Pact AV catheters delivered to customers worldwide. As of March 31, 2022, the company received zero complaints related to this problem, and no cases of injury or death related to this problem were recorded.

Medtronic withdraws defective balloon catheters due to sterility issues

Medtronic discovered damage to the case during a routine check. Further investigation showed that the reason was a change made to one production line. All shipments made on this line after making changes are withdrawn at the end of March 2022, and the problem on this line has been fixed, the company said. In addition, in order to avoid further problems, Medtronic suspended production on all lines until a re-inspection of the package was carried out and additional errors were found.

The IN.PACT Admiral and and In.Pact AV drug-coated paclitaxel balloon is an effective and safe method of treating lower extremity arterial stenosis. The method of treatment is based on transdermal transluminal balloon angioplasty of arteries followed by accumulation of paclitaxel drug in tissues of vessel wall.

For patients who used In.Pact Admiral and In.Pact AV drug-coated balloon catheters during the procedure, no action is required. The company said Medtronic is appealing to customers with the affected product in their hands to quarantine it immediately and return it along with the signed confirmation form.^[1]

2019: Announcement

At the end of November 2019, Medtronic introduced a paclitaxel coated cylinder. The product is called IN.PACT AV. It is designed to correct recurrent vascular lesion that interferes with dialysis in patients with end-stage renal failure.

In many cases, arterio-venous fistulas are considered an absolutely necessary condition for patients with end-stage renal failure, since they are the main access point for dialysis. When these access points fail, dialysis is postponed indefinitely, and patients have to endure many surgical procedures to restore fistula patency, "explained Dr. Vincent Gallo, a specialist in interventional radiology who participated in in IN testing. PACT AV.

Medtronic Introduces Paclitaxel Coated Cylinder IN.PACT AV

Gallo noted that with the new device, doctors will have access to safe and extremely effective therapies that will slow the progression of repeated stenosis, which means reducing the need for repeated operational interventions and ensuring stable dialysis of severe patients.

The study of the IN.PACT AV device involved 330 people from 29 research centers in the United States, New Zealand and Japan. According to the results of a semi-annual study in patients who used IN.PACT AV, fistula patency persisted longer, and repeated surgical interventions were required 56% less often than in patients who underwent standard percutaneous transluminal angioplasty.

Professor Robert Lookstein noted that until now there were virtually no available treatments for arterio-venous fistula stenosis that maintained patency and reduced the need for repeated surgical interventions for a long time. This niche should now be occupied by the IN.PACT AV device.^[2]

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