The U.S. Food and Drug Administration (FDA) recently told health care providers that there is an increased rate of major cardiac events seen in patients treated with an Abbott Inc. medical device implanted during heart surgery. Providers were told to be sure to follow recommendations for its implantation. In a March 18 letter, the FDA said that there is a higher rate of adverse cardiac events seen in patients treated with Abbott’s Absorb GT1 Bioresorbable Vascular Scaffold, or BVS, compared to those treated with another Abbott-made device, the Xience stent. The BVS is implanted during an angioplasty and it gradually dissolves over time and is absorbed by the body. The BVS is used to open coronary arteries blocked by scar tissue in order to increase blood flow to the heart muscle. The FDA approved the device in July of last year.
In its initial review of two-year data from a pivotal study of the BVS, the FDA said that there is an 11 percent rate of major events like heart attacks or the need for another procedure to reopen the heart vessel, compared with a nearly 9 percent rate in patients treated with the Xience stent. The study also shows a close to 2 percent rate of developing blood clots with the BVS, compared to a lower than 1 percent rate with the Xience stent, the FDA said. “These observed higher adverse cardiac event rates in BVS patients were more likely when the device was placed in small heart vessels,” the FDA wrote in the letter.
Another analysis suggests that there’s a lower rate of complications when health care providers follow the recommended implantation methods, the FDA said. The agency told health care providers to avoid using the BVS in small heart vessels, as per its instructions, and to tell patients who experience new cardiac symptoms such as irregular heartbeats, chest pain or shortness of breath to seek medical attention.
The FDA also told providers to follow the instructions for best device implantation, which are included in the BVS physician labeling. An Abbott spokeswoman told Law360:
The FDA’s letter to health care providers emphasized the importance of following instructions for use when implanting Absorb. When implanted in appropriately sized vessel sizes and following current instructions for use, the results for Absorb are comparable to the leading metallic drug-eluting stent – with the added feature of leaving no metal behind once it dissolves.
The FDA said that it is working with Abbott to carry out more analyses to better understand the causes of higher cardiac events and blood clots in patients treated with BVS compared with those treated with the Xience stent. “The FDA will continue to monitor the performance of the BVS in ongoing clinical studies and in reports submitted to FDA through MedWatch,” the agency said. The FDA urged providers to report any adverse events related to the BVS that comes to their attention and to submit a voluntary report through MedWatch, its safety information and adverse event reporting program, if they suspect any problems with the device.
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