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EMBOL-X Aortic Filter FDA Presenters Catherine Wentz Julie Swain, MD Gerry Gray, PhD

EMBOL-X Aortic Filter FDA Presenters Catherine Wentz Julie Swain, MD Gerry Gray, PhD. Brief Description.

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EMBOL-X Aortic Filter FDA Presenters Catherine Wentz Julie Swain, MD Gerry Gray, PhD

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  1. EMBOL-X Aortic FilterFDA PresentersCatherine WentzJulie Swain, MDGerry Gray, PhD

  2. 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.

  3. 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

  4. 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

  5. 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 EMBOL-X), 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.

  6. 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.

  7. 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.

  8. 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.

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