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Aortic stent grafts

Zenith Alpha

by William Cook Europe ApS

A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.

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Zenith Alpha models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
G35327— MR ConditionalAvailable
G35328— MR ConditionalAvailable
G35329— MR ConditionalAvailable
G35330— MR ConditionalAvailable
G35331— MR ConditionalAvailable
G35332— MR ConditionalAvailable
G35333— MR ConditionalAvailable
G35334— MR ConditionalAvailable
G35335— MR ConditionalAvailable
G35336— MR ConditionalAvailable
G35337— MR ConditionalAvailable
G35338— MR ConditionalAvailable
G35339— MR ConditionalAvailable
G35340— MR ConditionalAvailable
G35341— MR ConditionalAvailable
G35342— MR ConditionalAvailable
G35343— MR ConditionalAvailable
G35344— MR ConditionalAvailable
G35345— MR ConditionalAvailable
G35346— MR ConditionalAvailable
G35347— MR ConditionalAvailable
G35348— MR ConditionalAvailable
G35349— MR ConditionalAvailable
G35350— MR ConditionalAvailable
G35351— MR ConditionalAvailable
G35352— MR ConditionalAvailable
G35353— MR ConditionalAvailable
G35354— MR ConditionalAvailable
G35355— MR ConditionalAvailable
G35356— MR ConditionalAvailable
G35357— MR ConditionalAvailable
G35358— MR ConditionalAvailable
G35359— MR ConditionalAvailable
G35360— MR ConditionalAvailable
G35361— MR ConditionalAvailable
G35362— MR ConditionalAvailable
G35363— MR ConditionalAvailable
G35364— MR ConditionalAvailable
G35365— MR ConditionalAvailable
G35366— MR ConditionalAvailable
G35367— MR ConditionalAvailable
G35368— MR ConditionalAvailable
G35369— MR ConditionalAvailable
G35370— MR ConditionalAvailable
G35371— MR ConditionalAvailable
G35372— MR ConditionalAvailable
G35373— MR ConditionalAvailable
G35374— MR ConditionalAvailable
G35375— MR ConditionalAvailable
G35376— MR ConditionalAvailable
G35381— MR ConditionalAvailable
G35382— MR ConditionalAvailable
G35383— MR ConditionalAvailable
G35384— MR ConditionalAvailable
G35385— MR ConditionalAvailable
G35386— MR ConditionalAvailable
G35391— MR ConditionalAvailable
G35392— MR ConditionalAvailable
G35393— MR ConditionalAvailable
G35394— MR ConditionalAvailable
G35395— MR ConditionalAvailable
G35396— MR ConditionalAvailable
G35397— MR ConditionalAvailable
G35398— MR ConditionalAvailable
G35399— MR ConditionalAvailable
G35400— MR ConditionalAvailable
G35401— MR ConditionalAvailable
G35402— MR ConditionalAvailable
G35403— MR ConditionalAvailable
G35404— MR ConditionalAvailable
G35502— MR ConditionalAvailable
G35503— MR ConditionalAvailable
G35504— MR ConditionalAvailable
G35505— MR ConditionalAvailable
G35506— MR ConditionalAvailable
G35507— MR ConditionalAvailable
G35509— MR ConditionalAvailable
G35510— MR ConditionalAvailable
G35511— MR ConditionalAvailable
G35512— MR ConditionalAvailable
G35513— MR ConditionalAvailable
G35514— MR ConditionalAvailable
G35515— MR ConditionalAvailable
G35516— MR ConditionalAvailable
G35517— MR ConditionalAvailable
G35518— MR ConditionalAvailable
G35519— MR ConditionalAvailable
G35520— MR ConditionalAvailable
G35521— MR ConditionalAvailable
G35522— MR ConditionalAvailable
G35523— MR ConditionalAvailable
G35524— MR ConditionalAvailable
G35525— MR ConditionalAvailable
G35526— MR ConditionalAvailable
G36346— MR ConditionalAvailable
G38023— MR ConditionalAvailable
G38024— MR ConditionalAvailable
G38025— MR ConditionalAvailable
G38027— MR ConditionalAvailable
G38028— MR ConditionalAvailable
G38041— MR ConditionalAvailable
G38055— MR ConditionalAvailable
G38072— MR ConditionalAvailable
G38075— MR ConditionalAvailable
G38171— MR ConditionalAvailable
G38172— MR ConditionalAvailable
G38173— MR ConditionalAvailable
G38178— MR ConditionalAvailable
G38179— MR ConditionalAvailable
G38180— MR ConditionalAvailable
G38190— MR ConditionalAvailable
G38191— MR ConditionalAvailable
G38201— MR ConditionalAvailable
G38203— MR ConditionalAvailable
G38204— MR ConditionalAvailable
G38208— MR ConditionalAvailable
G38216— MR ConditionalAvailable
G38220— MR ConditionalAvailable
G38236— MR ConditionalAvailable
G59910— MR ConditionalAvailable
G59912— MR ConditionalAvailable
G59915— MR ConditionalAvailable
G59918— MR ConditionalAvailable
G59921— MR ConditionalAvailable
G59923— MR ConditionalAvailable
G59926— MR ConditionalAvailable
G59932— MR ConditionalAvailable
G59935— MR ConditionalAvailable
G59938— MR ConditionalAvailable
G59941— MR ConditionalAvailable
G59944— MR ConditionalAvailable
G59947— MR ConditionalAvailable
G59950— MR ConditionalAvailable
G59956— MR ConditionalAvailable
G59958— MR ConditionalAvailable
G59960— MR ConditionalAvailable
G59965— MR ConditionalAvailable
G59969— MR ConditionalAvailable
G59972— MR ConditionalAvailable
G59975— MR ConditionalAvailable
G59978— MR ConditionalAvailable
G59981— MR ConditionalAvailable
G59984— MR ConditionalAvailable
G59987— MR ConditionalAvailable
G59990— MR ConditionalAvailable
G59993— MR ConditionalAvailable
G59996— MR ConditionalAvailable
G59999— MR ConditionalAvailable
G60002— MR ConditionalAvailable
G60005— MR ConditionalAvailable
G60008— MR ConditionalAvailable
G60011— MR ConditionalAvailable
G60014— MR ConditionalAvailable
G60017— MR ConditionalAvailable
G60020— MR ConditionalAvailable
G60023— MR ConditionalAvailable
G60026— MR ConditionalAvailable
G60029— MR ConditionalAvailable
G60032— MR ConditionalAvailable
G60035— MR ConditionalAvailable
G60039— MR ConditionalAvailable
G60040— MR ConditionalAvailable
G60043— MR ConditionalAvailable
G60046— MR ConditionalAvailable
G60049— MR ConditionalAvailable
G60052— MR ConditionalAvailable
G60055— MR ConditionalAvailable
G60058— MR ConditionalAvailable
G60061— MR ConditionalAvailable
G60064— MR ConditionalAvailable
G60067— MR ConditionalAvailable
G60070— MR ConditionalAvailable
G60073— MR ConditionalAvailable
G60076— MR ConditionalAvailable
G60079— MR ConditionalAvailable
G60082— MR ConditionalAvailable
G60084— MR ConditionalAvailable
G60093— MR ConditionalAvailable
G60097— MR ConditionalAvailable
G60105— MR ConditionalAvailable
G60109— MR ConditionalAvailable
G60116— MR ConditionalAvailable
G60130— MR ConditionalAvailable
G60142— MR ConditionalAvailable
G60154— MR ConditionalAvailable
G60157— MR ConditionalAvailable
G60159— MR ConditionalAvailable
G60165— MR ConditionalAvailable
G60171— MR ConditionalAvailable
G60174— MR ConditionalAvailable
G60177— MR ConditionalAvailable
G60180— MR ConditionalAvailable
G60183— MR ConditionalAvailable
G60186— MR ConditionalAvailable
G60189— MR ConditionalAvailable
G60192— MR ConditionalAvailable
G60195— MR ConditionalAvailable
G60198— MR ConditionalAvailable
G60201— MR ConditionalAvailable
G60204— MR ConditionalAvailable
G60207— MR ConditionalAvailable
G60210— MR ConditionalAvailable
G60212— MR ConditionalAvailable
G60215— MR ConditionalAvailable

FDA clearances

Procedures that use aortic stent grafts

Endovascular Aneurysm Repair (EVAR)

Frequently asked questions

What is Zenith Alpha used for?

A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.

Who makes Zenith Alpha?

Zenith Alpha is made by William Cook Europe ApS. It is listed under aortic stent grafts (evar/tevar) in our device library.

What sizes does Zenith Alpha come in?

The FDA device database does not list sizes for Zenith Alpha. Check the instructions for use or ask a William Cook Europe ApS representative.

Is Zenith Alpha MRI safe?

The FDA device database lists Zenith Alpha as MR Conditional. Always follow the specific MRI conditions in the labeling.

Is Zenith Alpha FDA cleared?

Zenith Alpha is covered by FDA submission P140016.

How do I contact a William Cook Europe ApS sales representative?

William Cook Europe ApS has not listed representatives on LA Vascular yet. Visit the William Cook Europe ApS company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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