St. Jude Medical ($STJ) got sideswiped with an FDA safety alert over one of the company's heart plugs based on reports that it could potentially wear away tissue and, ironically, create more holes.
Regulators said that problems with the Amplatzer Atrial Septal Occluder (ASO) are "very rare," with reported issues from up to three out of every 1,000 patients implanted with the device. The FDA itself said it received more than 100 reports of tissue "erosions" involving the device between 2002 and 2011, coinciding with medical journal articles addressing the same issue.
The alert comes in the wake of an FDA public advisory committee meeting held in May 2012 in which regulators met to discuss the safety and effectiveness of atrial septal defect closure devices, and reviewed adverse events including the possible risk of tissue erosion in the wake of ASO implants.
St. Jude spokeswoman Kristi Warner told FierceMedicalDevices that "we respect the role of the FDA and share their goal of protecting patient safety. St. Jude Medical's Amplatzer Septal Occluder (ASO) remains a safe and reliable option for atrial septal defect (ASD) closure and is the most studied pediatric intra-cardiac, percutaneous device in the market, with over 225,000 ASO devices sold worldwide."
Even so, St. Jude now has extra work to do. The FDA is requiring St. Jude to launch a clinical study of patients recently implanted with the device to gather more data, including how many patients face tissue erosion problems within a week, a month, 6 months and one year after the Amplatzer ASO implant, according to the safety alert.
According to regulators, 234,103 Amplatzer ASO devices were sold globally as of March 31, 2013. The Amplatzer ASO is used to treat an atrial septal defect, or hole, between the upper left and right chambers of the heart, and is implanted through a catheter inserted into a vein. As the FDA explains, the device is considered to be a minimally invasive alternative to open heart surgery.
Regulators urge clinicians to review updated instructions for use of the device and to notify patients about tissue erosion risks. They're warned to urge patients with the implant to seek medical attention if they face chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath or a rapid heartbeat. But the FDA does not recommend outright removal of the device because "the risks associated with device removal surgery may be equal or greater than the risk of erosion."
St. Jude recently lost a patent suit that had attempted unsuccessfully to banish Gore's rival Helex Septal Occluder from the market. The company reported booming net income and profit in its 2013 third quarter, buttressed by job cuts, cost cutting and restructuring.
- here's the full FDA alert
Editor's note: This story is updated to include comments from St. Jude Medical.