New research is raising questions about the safety of a heart device coating used in a component sold by St. Jude Medical.
Dr. Robert Hauser of Abbott Northwestern Hospital in Minneapolis has been following a number of cases reported to the Food and Drug Administration, in which a material used to coat wires in the implant is breaking down prematurely.
St. Jude’s claims that this Optim covering provides better protecting for defibrillator leads than traditional silicone coatings. The company has been active in defending its products and has announced that it will monitor patients with the product “indefinitely.”
In response to the release of Hauser’s report, the FDA has recommended that patients who received earlier versions of the St. Jude leads undergo imaging tests to determine if the device is beginning to fail. St. Jude’s has also been ordered to conduct more research on the durability of the leads.
If you have a a new or old generation of leads, the Durata or the Riata ST Optim, talk to your cardiologist about the risks of your defibrillator. Screening can help you determine if your implant is still functioning properly.
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Cardiology Associates is part of the Bon Secours Heart & Vascular Institute, a program that provides coordinated, personalized general and interventional cardiac care to residents of Hampton Roads, from Virginia Beach to Portsmouth and Newport News. Bhavdeep Gupta, MD, FACC and Apurva Patel, MD, FACC are both board certified cardiologists who specialize in sophisticated cardiovascular diagnostic and therapeutic services. To schedule an appointment with one of our expert cardiologists contact us today at 757.889.CARE.