News
February 2009 - CV surgeon results. Link
February 2009 - CARDIO's first patient successfully treated with Algisyl-LVR at the German Heart Center in Munich.
January 2009 - CARDIO receives IRB approval from German Heart Center in Munich for first-in-man Algisyl-LVR study.
December 2008 – CARDIO files IDE with US FDA for its Algisyl-LVR heart failure therapy with a view toward initiating a multi-center U.S. study in mid 2009.
December 2008 – CARDIO files for IRB and EU approval at three centers in Europe for its initial clinical study for Algisyl-LVR in patients undergoing open chest CABG or valve surgery.
June 2008 – CARDIO conducts pre-IDE meeting with US FDA for its Algisyl-LVR heart failure therapy.
May 2008 – CARDIO completes 32 patient safety study for its Plexisyl-AF product for the prevention of post-operative atrial fibrillation. IDE filing with U.S. FDA scheduled for early 2009.
February 2008 – CARDIO begins, at five world class heart centers in Germany, a 32 patient ‘randomized safety study’ for its Plexisyl-AF product for the prevention of post-operative atrial fibrillation in patients undergoing open chest cardiothoracic procedures using its second generation biomaterial.
January 2008 - CARDIO and ANGIOTEH Pharmaceuticals sign exclusive license agreement to utilize Angiotech’s implantable biodegradable polymer for the prevention of post-operative atrial fibrillation
September 2007 – CARDIO conducts pre-IDE meeting with US FDA for a multi-center U.S. clinical study for its Plexisyl-AF product for the prevention of post-operative atrial fibrillation.
June 2007 – CARDIO completes its large animal pre-clinical Algisyl-LVR validation study conducted by Dr. Hanni Sabbah, Ph.D. at Henry Ford Hospital Cardiac Research Center in Detroit.
May 2007 - CARDIO completes large animal pre-clinical study on its second generation biopolymer for its Plexisyl-AF product for the prevention of post-operative atrial fibrillation.
March 2007 - CARDIO completes European multi-center 54 patient clinical study using first generation biopolymer for post-operative atrial fibrillation.
Feb 2007 – CARDIO receives device classification from US FDA for its Algisyl-LVR product for the treatment of congestive heart failure and also for its Plexisyl-AF product for the prevention of post-operative atrial fibrillation.