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Summary from the Circulatory System Devices Panel Meeting - October 23, 2002

The 10/22/02 summary is available here.

DEVICE

A Panel meeting was held to discuss the EMBOL-X Aortic Filter 510(k) (K022071) in light of some issues raised during the 1289 patient clinical study, potentially affecting the safety and/or risk profile of the device.

The EMBOL-X Aortic Filter is “intended to contain and remove particulate emboli from the ascending aorta during and following cross-clamp removal and as the heart resumes ejection”. The heparin-coated filter has a pore size of 120 microns and is mounted on a nitinol frame. The filter is inserted into the ascending aorta via a side-port on the EMBOL-X Cannula. The flexible wire filter frame expands upon insertion into the vessel, and is available in 5 sizes. The filter is then retracted back through the same side-port at the end of the procedure.

DISCUSSIONS

The major issues discussed were:

1. Does the device demonstrate a reasonable safety profile in light of the equivalence safety endpoint and the endothelial injuries demonstrated with the device?
2. Can this method of embolic entrapment be extrapolated to clinical efficacy?
3. Labeling, specifically the appropriate patient population that should be identified in the indications for use and labeling.

The Panel concluded that the device demonstrated equivalent safety as compared to the control. The issue of the endothelial injuries was neutralized by the fact that short-term imaging data indicate that the injuries are not associated with short-term clinical events (7.0 days).

The Panel had several discussions, as has the FDA, on the issue of clinical efficacy and the fact that the study was unable to demonstrate any clinical benefit, although some capture of debris was noted in 96% of the filters deployed. Although intuitively one would assume that clinical benefit would be demonstrated with the capture of debris, it wasn’t demonstrated in this study. As such, the labeling should steer clear of these implications.

It was basically discussed that the labeling should include clearly and decisively the patient population studied, and that no safety data is available for patients outside the definition of those studied. Specific patient demographics from the study should be presented in the labeling, along with more precise explanations of the inclusion/exclusion criteria defined in the study.

CONCLUSIONS

For the patient population studied, the RISK/BENEFIT profile is neutral (i.e., no real risk, and no clinical benefit).

For a higher risk patient population, the RISK/BENEFIT profile is not clear (e.g., risk may be greater, but there may be clinical benefit).

Transcripts may be purchased from (written requests only)
Miller Reporting Company
735 8th Street, SE
Washington, DC 20003
(202) 546-6666 (voice), (202) 546-1502 (fax)

or

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20851
(301) 827-6500 (voice), (301) 332-1726 (fax)

Under normal circumstances, panel summary minutes are available 60-90 post meeting. Summaries are also available on the CDRH website: http://www.fda.gov/cdrh/panel/index.html

CDRH Advisory Committee Database

Updated 10/25/2002

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