FDA raises concerns about Medtronic heart device

Medtronic ($MDT) will be in the hot seat Thursday as it faces an FDA advisory panel regarding its percutaneous catheter system to treat persistent atrial fibrillation. The company faces some tough questions about the safety of the device, if FDA pre-meeting materials are any indication.

Although they found the device to be effective, FDA staffers expressed concern about the safety of the device, known as the Medtronic Ablation Frontiers cardiac ablation system, in materials posted ahead of the meeting. They pointed specifically to the high peri-procedural stroke rate observed in a study. "This concern is echoed by the recently published peer-reviewed reports suggesting that the PVAC (one of the three catheters included in this PMA) is associated with up to a five-fold higher incidence of asymptomatic cerebral embolic lesions as assessed by pre-and post ablation diffusion weighted MRI imaging when compared to other ablation catheters," the agency said.

Indeed, of a total of 176 subjects who received at least one study procedure, 5 experienced a stroke within one month, according to agency documents. 

Sanford Bernstein's Derrick Sung says, given the safety concerns, there is a 50% chance the panel will recommend the device, Reuters notes.

- see the FDA's assessment
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