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Our Solution - Innovative Devices for the Treatment of Diastolic Heart FailureCorAssist is developing a pipeline of elastic, self-expanding devices that are attached to the left ventricle, either externally or internally. The devices operate by transferring energy harnessed during systole (contraction) to the left ventricle during diastole (relaxation) to improve diastolic performance. CorAssist’s devices deal with the core problems of diastolic heart failure – the stiffening of the myocardial tissue and impaired relaxation – by directly enhancing the elastic characteristics of the left ventricular wall.ImCardia™The ImCardia™ is an elastic self-expanding device that is attached to the external left ventricular surface of the heart through a simple off-pump procedure. It applies an outward expansion force on the ventricular wall to improve diastolic dynamics and filling performance.Click here to see the ImCardia™ demo. In-vivo Safety evaluation on healthy model demonstrated that the device is safe at 12 months follow up (including: systolic performance, general clinical evaluation and extreme conditions tests). In-vivo Efficacy evaluation on diseased animal model with left ventricular hypertrophy revealed diastolic performance improvemt. Clinical safety study (ongoing): The ImCardia™ was implanted in patients admitted for Aortic Valve Replacement due to Aortic stenosis. Interim results (currently up to 2 years follow-up) revealed safety profile and showed trend of improvement in diastolic function parameters compared to the control group (Aortic valve replacement without ImCardia implantation). ImCardia™ MISThe ImCardia™ MIS is a second generation, minimally invasive version of the ImCardia™ device, and includes designated delivery tools which allow implantation through smaller incisions.CORolla™The CORolla™ is an elastic device implanted inside the left ventricle in a minimally invasive procedure through Trans Apical Approach (TAA) or Percutaneous Approach (PA) in an off-pump procedure. The device applies direct internal expansion forces distributed on the left ventricle wall and the septum to improve diastolic function.In-Vivo safety evaluation is ongoing; Safety after 6 months already demonstrated. Clinical study is planned to be initiated during 2011 Click here to see the CORolla™ TAA demo. |
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