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The Journal of Thoracic and Cardiovascular Surgery
Volume 136, Issue 1
, Pages 52-57
, July 2008
Deleterious outcome of No-React–treated stentless valved conduits after aortic root replacement: Why were Warnings ignored?
References
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- CE 0318 technical report. The NR-2000C stentless aortic valve conduit: a breakthrough in bioprosthetic design. Millburn (NJ): Shelhigh, Inc; USA.
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- Available at: http://www.fda.gov/foi/warning_letters/archive/m3695n.pdf. Accessed Aug 22, 2007.
- Available at: http://www.fda.gov/foi/warning_letters/archive/g5674d.pdf. Accessed Aug 22, 2007.
- FDA preliminary public health notification: possible contamination and malfunction of heart valves and valved conduits, annuloplasty rings, surgical grafts, meshes and other devices manufactured by Shelhigh, Inc. April 18, 2007. Available at: www.fda.gov/cdrh/safety/041807-shelhigh.html. Accessed Aug 22, 2007.
- . Creation of a self-made total artificial heart using combined components of available ventricular assist devices. Thorac Cardiovasc Surg. 2008;56:51–53
The Shelhigh NR-2000C is a totally biologic stentless conduit designed for the treatment of various aortic root pathologies. After implanting 115 conduits, 7 patients presented with disastrous findings, including aortic root rupture. Meticulous follow-up of those patients who already underwent implantation of this device has to be recommended.
Thierry Carrel reports terminating a previous relationship with Shelhigh.
PII: S0022-5223(07)01692-3
doi: 10.1016/j.jtcvs.2007.09.047
© 2008 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
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The Journal of Thoracic and Cardiovascular Surgery
Volume 136, Issue 1
, Pages 52-57
, July 2008
