Cook Medical announced submission of application for approval for a low profile endograft system for treatment of Abdominal Aortic Aneurysm (AAA). The low profile system is 16 Fr. in size compared to current diameters of 22-24 Fr for the main body. The large main body device profile may affect the ability to insert the device in under the circumstances of small access site diameter which is more common in women. Inability to insert the device at traditional access points in the groin may necessitate a more invasive pelvic incision or the inability to perform stent grafting and the need for traditional aneurysm surgery via an abdominal incision.
If approved, this technology improvement may reverse halt the slide in market share created by entry of the Talent Endograft from Medtronic. Although I have not seen the numbers, my perception is that there has been a migration to the Talent by some previous users of The Zenith device.
I would like to get some feedback regarding the number of proceduralist who would use percutaneous technique for the 16 Fr. It's a somewhat contradictory thought process that the subgroup that would most benefit from the small device size (elderly female, small vessels) is precisely the group that's most prone to complications from an attempt at percutaneous management of a 5 mm arteriotomy.
Editors note: The Veith Meeting is coming up. I hope to provide some real time updates regarding technology and industry events
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