Discussion on:

Stroke victims: Tiny coil saves lives by pulling blood clots from the brain

The way this is presented would make the public think that the Merci devise is a great advance. I think it is a marginal advance at best. I think the anecdotal experience that is the basis of the endorsement overly simplifies the collective experience in the literature with this device and a competing device.

I am disappointed to hear ads boasting about its availability of the Merci device at hospitals. The direct marketing to consumers of drugs and devices is a bad idea. It has a ripple effect. ERs are mistakenly asking to transfer patients to places where this is available instead of using the better treatments which they can use. The delay is clearly a big mistake.

The scientific paper that was used to gain approval of this and a competing device compared it with a medical option that could not get FDA approval. The Merci device and the competing device did only as well and often worse than an approach that was considered a medical failure. If the results reported for the Merci device were submitted under rules for a drug instead of a medical device I do not think it would not have been approved. The criteria for FDA approval are very different for drugs and devices.

It is hard to interpret anecdotal experience in stroke. Some stroke patient get better without help, making it hard to attribute success with a device. It is hard to convince someone that sees that a patient got better after doing things that it was not due to their intervention. The dark side of this story is the number of times the catheter caused serious problem.

The sad fact is that patients that receive treatment after 4.5 hours have few good options. Treatment before 3 hours is much better than at 4.5.

If the option were offered to me or my family before 4.5 hours I would absolutely reject it. I would choose TPA. After 4.5 hours I would probably choose no treatment but might well succumb to the hope that the MERCI device might help.

The videos are very seductive.

The way this is presented would make the public think that the Merci devise is a great advance. I think it is a marginal advance at best. I think the anecdotal experience that is the basis of the endorsement overly simplifies the collective experience in the literature with this device and a competing device.

I am disappointed to hear ads boasting about its availability of the Merci device at hospitals. The direct marketing to consumers of drugs and devices is a bad idea. It has a ripple effect. ERs are mistakenly asking to transfer patients to places where this is available instead of using the better treatments which they can use. The delay is clearly a big mistake.

The scientific paper that was used to gain approval of this and a competing device compared it with a medical option that could not get FDA approval. The Merci device and the competing device did only as well and often worse than an approach that was considered a medical failure. If the results reported for the Merci device were submitted under rules for a drug instead of a medical device I do not think it would not have been approved. The criteria for FDA approval are very different for drugs and devices.

It is hard to interpret anecdotal experience in stroke. Some stroke patient get better without help, making it hard to attribute success with a device. It is hard to convince someone that sees that a patient got better after doing things that it was not due to their intervention. The dark side of this story is the number of times the catheter caused serious problem.

The sad fact is that patients that receive treatment after 4.5 hours have few good options. Treatment before 3 hours is much better than at 4.5.

If the option were offered to me or my family before 4.5 hours I would absolutely reject it. I would choose TPA. After 4.5 hours I would probably choose no treatment but might well succumb to the hope that the MERCI device might help.

The videos are very seductive.