In a study being taken out by Dr. Robert G. Hauser, a prominent cardiologist from Abbott Northwestern Hospital, it has been recommended that a component being sold by St. Jude Medical for heart medical devices should be banned.
The study, which has been published in a British cardiology journal, EP Europace, is suggested to be stopped till the time its long term safety is being known. Hauser was of the view that the material, which is being used to coat wires that further connect with defibrillator is found to be ineffective at times.
The coating, which is named as Optim, was found to be quite effective, but since few years, the device has found to be failed. Hauser said that there are many cases, which have been registered with the Food and Drug Administration about the failure of the device.
Though cases have been registered with the FDA, the Optim manufacturing company has repeatedly defended the device by saying that success rate of product is 99.9%.
“St. Jude Medical is committed to continuing to make significant investments in technologies and post-market surveillance studies to further advance our insight into the performance of our leads”, said a statement being released by the company.
