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May 2008
The ImCardia™ Implantation procedure FIM was presented at the WCSTS PCR and Biomed 2008 conferences.
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April 2008
CorAssist is proud to announce FIM (First in Man) implantation in two patients. For the first time an innovative device-based solution has been implanted in human as part of the ImCardia™ for DHF – Safety and Functionality multicenter Pilot study. First follow up results are expected at the End of June 2008.
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March 2008
Efficacy in diseased animal demonstrates that in animal model in which hypertrophy was induced, 2D strain analysis revealed device related global and local diastolic improvement compared to control group.
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December 2007
CorAssist completed Pre-IDE meeting with the FDA in which the general path of ImCardia™ preclinical plan (in vivo and bench tests) and clinical plan was discussed and agreed. The meeting paved the way to initiation of the ImCardia ™ clinical study.
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November 2007
CorAssist has completed preliminary proof of concept for the ImCardia™ MIS, the second generation of its first product, the ImCardia™, which enables implantation of the device through a small incision.
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August 2007
CorAssist is proud to announce that it has obtained ISO certification (ISO 13485:2003) for its Quality Management System. ISO certification will allow the company to begin ImCardia™ manufacturing for clinical trials.
CorAssist has completed preliminary proof of concept for its second product, the CORolla, a new intraventricular device for diastolic heart failure.
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