VascuCel


 

Next generation collagen scaffold for restorative vascular repair.

VascuCel is bioengineered using the proprietary ADAPT Processing technology from Admedus. Used successfully in cardiac repairs and reconstructions for years, ADAPT technology is now available as a vascular patch. VascuCel Adapated Collagen Scaffold offers optimized healing and clinical performance, enhanced procedural efficiency and improved handling, for your broad spectrum of vascular surgical procedures.

VascuCel Vascular Repair Benefits

Optimized healing and clinical performance

  • No stimulus for thrombosis, inflammation, toxicity from aldehydes1,2,3
  • Harmonious healing3,4
  • No foreign body reaction, enabling endothelialization and new native tissue growth3,4
  • Terminally sterilized for reduced risk of infection5

A difference you can recognise.

Enhanced Procedural Efficiency

  • Ready to use off the shelf
  • No rise required
  • Hermostatic – resists suture line bleeding

A difference you can see.

Improved Handling

  • Supple, yet strong
  • Pliable, conformable6,7
  • Easy handling and suturability6,7

A difference you can feel.


VascuCel® is approved/cleared for sale in the US only. For more information on VascuCel®, please contact us here.


United States:Indications: VascuCel™ is indicated for use as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing. Contraindications: VascuCel™ is not designed, sold or intended for use except as indicated.

Warnings: To avoid damage to the product, do not expose to any substances other than those specified in the rinse procedure. Do not freeze. Do not expose the device to extreme heat. Do not re-sterilize. Single use only and cannot be re-used. Use of the device following a compromise in sterility may result in infection. Do not use beyond the indicated expiration date. Studies have not been performed to evaluate the safety or compatibility of this device during magnetic resonance imaging (MRI) scans. As such, the potential hazards of MRI testing on patients receiving this bioprosthesis are unknown.

For additional information please refer to the Instructions for Use provided with the product or contact your local Admedus representative.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

References:

  1. Neethling WML, et al. Enhanced Biostability and Bio-compatibility of Decellularized Bovine Pericardium, Crosslinked with an Ultra Low Concentration Monomeric Aldehyde and Treated with ADAPT™ J Heart Valve Di 2008; 17:456-464.
  2. Neethling WML, et al. Mitigation of Calcification and Cytotoxicity of a Glutaraldehyde-Preserved Bovine Pericardial Matrix: Improved Bio-compatibility After Extended Implantation in the Subcutaneous Rat Model. J Heart Valve Dis 2010; 19:778-785.
  3. Data on file
  4. Brizard et al. (December 2014). New engineering treatment of bovine pericardium confers outstanding resistance to calcification in mitral and pulmonary implantations in a juvenile sheep model. The Journal of Thoracic and Cardiovascular
  5. Surgery, Vol 148, No 6, Pgs 3194-3201.
  6. AAMI/ISO 11737-2: Sterilization of medical devices—Microbiological methods, Part 2: Tests of sterility performed in the validation of a sterilization process.
  7. Nelms, Justin, et al Carotid Patch Angioplasty with a novel collagen scaffold following carotid endarterectomy; 2016.
  8. Muto A, MD, PhD, el al. J Vasc Surg. 2009 July; 50(1):206-213.

VascuCel and ADAPT are trademark of Admedus Ltd. © 2016 Admedus. All Rights Reserved. USMK-M022 Rev 2