The Edwards Axela Sheath (model 9630ES14), as shown in Figure 7, also consists of a hydrophilic coated, expandable sheath and 2 dilators. It is available in 14 Fr inner diameter.
Edwards Axela Sheath Indications: The Edwards Axela sheath is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Ultra delivery system.
SAPIEN 3 Ultra Transcatheter Aortic Valve Device
Following this recall, the new delivery system and the Axela Sheath were replaced by the previous-generation Edwards Commander (Edwards Lifesciences) and the eSheath (Edwards Lifesciences).
SAPIEN 3 Ultra — Design and procedural features of a new …
2020年5月18日 · The Axela sheath is an expandable, and self-collapsible 14 F system with a hydrophilic coating. The expansion of the sheath is transient as it has an outer elastomeric jacket which forces active contraction of the sheath walls after valve passage. The 14 F sheath is compatible with all valve sizes.
MAUDE Adverse Event Report: EDWARDS LIFESCIENCES AXELA SHEATH…
MAUDE Adverse Event Report: EDWARDS LIFESCIENCES AXELA SHEATH/ESHEATH; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED. Exemption number e2016006, this report summarizes 10 events of major...
True Anatomical Fit: Tailored height and shape. Conformability and sealing with optimized radial force and interference across annular ranges. Coaptation in non-circular anatomy with supra-annular valve position. AOA® Anti-Mineralization Treatment: Reduce …
AccessGUDID - DEVICE: Axela Sheath (00690103200782)
2024年3月20日 · It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood …
tal tip. Finally, the Axela sheath has replaced the eSheath with new features. It is a 14 Fr expandable sheath for all valve sizes, includ-ing the 29 mm SAPIEN 3. It has a hydrophilic coating for smooth insertion, tracking and removal. The specific design allows tran-sient expansion and active contraction and, by means of a seamless
SAPIEN 3 Ultra — Design and procedural features of a new …
2013年1月2日 · valve; C. Delivery system; D. Axela sheath with a cross-section showing an outer elastomeric jacket and a folded expandable wall of the inner sheath. Modified from images provided by Edwards ...
S3 29-mm mounted on the Ultra delivery system. Moreover, the Axela sheath replaced the eSheath with new features. It is a 14 Fr expand-able sheath for all THV size including the S3-Ultra 29-mm with a new delivery system.6 2.3 | MDCT and echocardiographic image assessment All MDCT examinations were reviewed by two experienced interven-