CAESAREA, Israel, May 1, 2012 /PRNewswire/ --
CardioDex announces initial commercial use of a groundbreaking femoral access site closure device. Recent data from commercial use of the device on 41 patients at St Marien Hospital in Siegen Germany showed 100% success rate and no complications. "We are very excited about these new data that demonstrates that this device provides a viable treatment for a major unmet medical need due to the increasing use worldwide of percutaneous femoral access and the subsequent high rate of complications seen" said Dr. Hans Peter Hobbach, Deputy Chief of St Marien Hospital cardiac catheterization laboratory.
The new CardioDex thermal femoral artery closure device was used in 25 diagnostic cases and 16 interventional cases. The 100% success rate was obtained for normal or diseased femoral vessels with calcified plaque. According to Dr Shimon Eckhouse, Chairman and founder of CardioDex Ltd., "These very positive results confirm the data we observed in the first single-center clinical trial, that were presented earlier this year. This demonstrated performance of the Cardiodex closure device opens the door to a whole new and long awaited era for femoral arterial access and closure." One of the most exciting features of the device is the extremely short period before patient ambulation, diagnostic patients were ambulated within 2 hours and PCI (Percutaneous Coronary Intervention) patients were ambulated within 4 hours. There were no cases of hematoma or late bleeding, despite the fact that PCI patients were fully anticoagulated with heparin, aspirin and clopidogrel. Neither were there any cases of post procedural discomfort.
Method of action
The mechanism of action of the CardioDex device is based on controlled thermal closure of the arterial puncture site. The device consists of a temporary Nitinol anchor which is delivered via an existing introducer sheath and used to
|SOURCE CardioDex Ltd.|
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