Advisory committee found efficacy, not safety in cardiac ablation system

The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee today did not recommend for approval the cardiac ablation system developed by Medtronic for the treatment of atrial fibrillation.

Ten out of 10 committee members voted that there is assurance of effectiveness of the Ablation Frontiers Cardiac Ablation System, but nine out of 10 deemed the ablation system as unsafe. The panel voted eight to two that the benefits of the system do not outweigh the risks.

According to the executive summary presented by Medtronic, there was a 90% or greater reduction in AF or atrial flutter burden at 6 months in more than 55% of patients treated with the cardiac ablation system. Clinically relevant improvements in quality of life measures and reduction in symptom severity were also noted.

However, results also showed a peri-procedural stroke rate of 2.8% among 176 patients in the study, as well as ischemic stroke in five patients within one month of the study procedure. The committee members found these results to be of concern, and said the ablation system was not yet ready for approval.

Committee member John Hirshfeld, MD, of the University of Pennsylvania, offered suggestions to Medtronic on ways to move toward approval for the device. “What I suggest needs to be done in order to move this device to a more approvable status is that in the process of evaluating it we need a more robust metrics of benefit,” he said. “If future data gathering will provide really robust, convincing evidence of substantial, durable, clinical benefit, both symptomatic as well as for hard clinical outcomes, I think that will be the most beneficial way to move this device from its current status to a more approvable status.”

The device comprises a multichannel radiofrequency ablation generator; cardiac ablation catheters; and system components and accessories. It is a percutaneous catheter system that blocks or destroys electronic conduction patterns characteristic of AF by creating a series of transmural lesions from the endocardial surface of the left atrium.

The device was approved for use in the European Union in December 2006. However, questions about the safety of the device have been raised and are expected to be a topic of discussion.

Although the FDA is not required to follow the recommendations of the advisory committees, it usually does.

Disclosure: The researchers report no relevant financial disclosures.

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