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Deployment Poster

Deployment Poster

Product catalog summary
Overview: The document outlines the deployment technique for the Treovance stent-graft, a medical device certified by SGS under Council Directive 93/42/EEC. It is currently investigational in the United States and manufactured by Bolton Medical España, S.L.U.
Deployment Procedure:
  • Initial Positioning: Advance the device over the guidewire until the proximal markers are at the deployment site in the aorta. Ensure correct radial orientation of the contralateral gate.
  • Bifurcate Deployment: Rotate the grey grip clockwise to start deploying the stent-graft until the contralateral leg is exposed.
  • Release Mechanism: Release the bare stent by rotating the thumb screw counterclockwise and advance the delivery system to align the proximal markers of the leg extension.
  • Leg Extension Deployment: Open the Release Knob on the hub and move the Hub towards the Hand Grip to deploy the leg extension, monitoring under fluoroscopy.
  • Final Steps: Release the ipsilateral leg by adjusting the Turn Knob, remove the Main Thumb Screw, and detach the sheath. Perform a final angiogram to assess aneurysm or lesion exclusion.
Contact Information: For more information, contact Bolton Medical at the provided international or USA phone numbers.
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Catalog excerpts

Deployment Poster-1

PRECISE AND SAFE DEPLOYMENT TECHNIQUE BIFURCATE ADVANCEMENT Advance the device over the guidewire until the proximal markers are at the deployment site (in the aorta). Check the radial orientation of the contra­ la­eral gate. Rotate the grey t grip clockwise (in direction of arrow) to start the deployment of the stent-graft. PROXIMAL CLASPING RELEASE Deploy the device until the contralateral leg is exposed. Release the bare stent by rotating the thumb screw counterclockwise until the spacer releases. Then move the knob towards the guide wire flush port. system until the proximal markers of the leg extension are located between the minimum and maximum overlap markers on the main body contralateral leg. Take care to view the distal marker position in the same field of view. SHEATH DETACH Completely open the Release Knob on the hub. While holding the Hand Grip fixed, move the Hub towards the Hand Grip to start deploying the leg extension. Closely monitor the expansion of the leg extension under fluoroscopy to ensure proper location of all markers and adjust as necessary. Completely open the Release Knob on the hub. While holding the Hand Grip fixed, move the Hub towards the Hand Grip to start deploying the leg extension. Closely monitor the expansion of the leg extension under fluoroscopy to ensure proper location of all markers and adjust as necessary. the bifurcated device by moving the Turn Knob back until seated against the back end of main delivery system handle. Loosen and remove the Main Thumb Screw. Separate the sheath from main handle. FINAL ANGIOGRAM final angiogram to assess aneurysm/lesion exclusion. For more information, contact Bolton Medical at +34-93-817-63-23 (International) or 1-954-838-9699 (USA). www.boltonmedical.com TREOVANCE is certified by SGS (0120) according to Council Directive 93/42/EEC as amended 2007/47/EC US Only - Treovance: CAUTION - Investigational Device. Limited by United States law to investigational use Manufacturer: Bolton Medical España, S.L.U. C\ Newton 18-24, 08635 - Sant Esteve Sesrovires, Barcelona, Spain +34. 938.176.323 U.S. Headquarters. Bolton Medical Inc. 799 International Parkway, Sunrise, FL 33325, +1.954.838.9699 BIFURCATE DEPLOYMENT

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