Injuries in Aptus Stent-Graft Trial Blamed on Poor Oversight

A clinical trial for the <"">Aptus AAA Endovascular Repair System, a stent-graft being developed by Aptus Endosystems Inc., has highlighted weaknesses in the way the Food & Drug Administration (FDA) regulates medical devices, according to a report in The Wall Street Journal. During the study for the aortic-aneurysm treatment, a high number of subjects developed blood clots because of defects in the way they were manufactured. Unfortunately for patients receiving the stent-grafts, the FDA hadn’t inspected or audited the plant where they were made before the devices were implanted in their aortas.

Apparently, that’s not unusual, according to The Wall Street Journal. While the FDA regularly inspects manufacturing sites when medical-device makers apply for marketing approval, the agency doesn’t generally do so at the earlier clinical-trial stage. This could be putting many clinical trial participants at risk for receiving defective medical devices.

The Aptus stent-graft was designed to treat aortic aneurysms, which are bulges in the aorta, the main artery carrying blood through the abdomen to vital organs. If such an aneurysm bursts, it can be fatal, the Journal said. While aortic aneurysms can be repaired surgically, doctors are choosing to treat them by inserting stent-grafts into the artery more often.

According to The Wall Street Journal, the first stage of the Aptus AAA trial began in 2006 with 21 patients. Only a handful of clots occurred and they didn’t appear unusual. The second stage commenced in 2007, with 155 more patients. By 2009, 28 percent of those had experienced a blood clot – a rate one of the study’s co-directors termed “extremely unusual” and “a very big deal.”

The study ended after the second stage. Since then, more clots have appeared in Aptus AAA recipients, the Journal said. In many cases, many of the clots required surgery, and were limb threatening.

It now appears the Aptus AAA stent-grafts were sewn together incorrectly so clots formed, blocking circulation and in some cases floating down into legs, the Journal said. Aptus has confirmed there was manufacturing defect, but won’t comment on what specifically went wrong.

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