Transcript EMBOL-X Aortic Filter FDA Presenters Catherine Wentz Julie Swain, MD

EMBOL-X Aortic Filter
FDA Presenters
Catherine Wentz
Julie Swain, MD
Gerry Gray, PhD
Brief Description
The EMBOL-X Aortic Filter, used in conjunction with the
EMBOIL-X Aortic Cannula (K020693 – cleared 9/5/02), 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.
Regulatory History
• 510(k)
– requires a manufacturer to demonstrate
substantial equivalence (SE) to a legally
marketed predicate device
• Substantial Equivalence
– same intended use
– similar technology
– if not similar technology, then means by which to
demonstrate that the new technology does not
affect equivalent performance and risk profile
Regulatory History
• PMA
– the FDA process by which to evaluate class III
medical devices
– Class III devices are usually those that
support or sustain human life, are of
substantial importance in preventing
impairment of human health, or which present
a potential, unreasonable risk of illness or
injury
Regulatory History
The EMBOL-X Aortic Filter originally underwent a clinical
study to demonstrate the safety and effectiveness of the
device in support of a PMA application. However, in
June 2001, the PercuSurge device (an embolic
protection device) was cleared through the 510(k)
regulatory pathway opening the doors for the EMBOL-X
Aortic Filter to be reviewed under the 510(k) regulations.
The PercuSurge device (similar intended use to EMBOLX), in conjunction with CPB Arterial Line Blood Filters
(similar technology to EMBOL-X) will be used as a
combination predicate for the EMBOL-X device in the
determination of substantial equivalence under the
510(k) regulations.
Endpoints for the Study
• Sponsor wanted a non-clinical
effectiveness endpoint (i.e., capture
debris), and an equivalence safety study
• FDA consistently expressed concerns
regarding the interpretability of the
proposed endpoints.
• FDA agreed to proposed effectiveness
endpoint assuming that the safety
endpoint (which included some neurologic
outcomes and other embolic related
events) would capture the clinical
effectiveness of the device.
• Device labeling would be restricted to only
the facts from the study. No clinical
implications could be made from the
capture of debris since none were
evaluated.
In Vitro Testing
• Bench studies – some design concerns and/or
test method concerns remain that may be
related to the endothelial injuries observed with
this device. These concerns are presently being
addressed.
• Biocompatibility – results indicate that the device
is non-toxic for the intended duration of use.
• Sterilization/Packaging/Shelf-life – single-use
and sterile with a shelf-life of 2 years.