CardioDex has announced initial commercial use of a new femoral access site closure device. Recent data with the device in 41 patients at St Marien Hospital, Siegen, Germany, showed 100% success rate and no complications.
“We are very excited about these new data that demonstrate 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 Hans Peter Hobbach, deputy chief of St Marien Hospital’s cardiac catheterisation 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 Shimon Eckhouse, chairman and founder of CardioDex, “these very positive results confirm the data we observed in the first single-centre clinical trial, that were presented earlier this year. This demonstrated that the performance of 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, according to CardioDex, is the extremely short period before patient ambulation – diagnostic patients were ambulated within two hours and percutaneous coronary intervention patients were ambulated within four hours. There were no cases of haematoma or late bleeding, despite the fact that percutaneous coronary intervention 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 locate the puncture site. The fully controlled heating step is made possible by an integrated battery power unit and a heating system that is inserted over the nitinol anchor wire on the site of the arteriotomy. Local short heating pulses provide sufficient haemostasis through the cross linking of collagen, leaving no residual material at the puncture site.
While some of the newer closure devices can be used in patients considered to be at high risk, such as those with peripheral arterial disease and smaller calibre arteries, the CardioDex device can be used in all types of patients and situations, including bifurcations, peripheral arterial disease, superficial femoral arterial punctures as well as in very thin or obese patients.
Charles Davidson, clinical chief, Cardiology Medical Director, Bluhm Cardiovascular Institute Northwestern Memorial Hospital and CardioDex’s chief medical officer stated that: “Thermal closure of the arterial puncture site has several potential advantages including nothing left behind and the ability to address challenging anatomies. The initial successful cases we have had demonstrate the promise of this new technology.”