Updated October 17, 2013, at 5 p.m.
FDA medical device regulators updated their safety warnings on St. Jude Medical’s (NYSE:STJ) troubled Amplatzer ASO atrial septal defect closure device, warning that the implant may cause tissue erosion in the heart.
Healthcare regulators received reports of more than 100 cases of Amplatzer-related erosion from 2002 to 2011, and although the issue is rare it may be life-threatening, according to the FDA notice. The agency has asked St. Jude to conduct new studies following Amplatzer ASO patients at 1, 6 and 12 months following treatment.
The FDA update is the outcome of a public advisory committee meeting conducted more than a year ago, where FDA regulators met to review and discuss potential dangers of septal defect closure devices, St. Jude spokeswoman Kristi Warner told MassDevice.com.
"We respect the role of the FDA and share their goal of protecting patient safety," Warner said. "St. Jude Medical’s Amplatzer Septal Occluder remains a safe and reliable option for atrial septal defect closure and is the most studied pediatric intra-cardiac, percutaneous device in the market, with over 225,000 ASO devices sold worldwide."
The Amplatzer ASO implant may rub against the walls of the heart, where it may create a hole, erode through tissue in the upper chambers of the heart or cause holes in the aortic root, resulting in open-heart surgery to remove the device, close the holes and repair the damage, the FDA warned.
"The FDA has not yet identified risk factors related to the occurrence of erosion," the FDA said. "This type of device failure has not been seen in similar devices used to treat this condition."
The federal watchdog agency noted that "most people implanted with the Amplatzer ASO experience good outcomes and that erosion is a very rare event," but asked that physicians talk to patients about the potential for erosion and to immediately report any suspected cases.
St. Jude’s Amplatzer line has had a rough path since the company unveiled 1 year ago that clinical trials failed to significantly reduce cryptogenic stroke compared with standard treatment with drugs in patients treated for a defect called patent foramen ovale. The news sent STJ shares sinking on Wall Street and put fellow PFO closure devices makers on the defensive.
Earlier this year the medical device giant revisited data from the failed RESPECT study, touting new findings that patients with the Amplatzer device had fewer and smaller strokes than patients who received drug therapy alone.
"The overall trial demonstrates that PFO closure with the Amplatzer PFO Occluder for these relatively young, otherwise healthy patients substantially reduces their risks of suffering another stroke," St. Jude cardiovascular & ablation technologies president Frank Callaghan said at the time.
*Corrected October 17, 2013, at 5 p.m.: This article mistakenly referenced the Amplatzer device in treatment of patent foramen ovale. The new FDA report is for Amplatzer ASO in treatment of atrial septal defects.