New vascular closure device launched

The ExoSeal™ Vascular Closure Device, which incorporates a number of new advances in technology and simplicity of design has been launched by the Cordis Corporation during EuroPCR, in Paris recently.

According to the manufacturers, ExoSeal™ was shown in a recent clinical trial to have an excellent clinical safety* profile during vascular procedures.

Marcus Wiemer, MD, Investigator of the ECLIPSE trial, Department of Cardiology, Heart and Diabetes Center North Rhine Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany

The ‘ECLIPSE Trial’ recorded no adverse clinical events and achieved a level of safety comparable to manual compression while significantly reducing time to ambulation. The device has achieved this level of clinical safety by combining easy-to-use functionality with trusted bioabsorbable technology and precise extravascular closure.

The ExoSeal™ Vascular Closure Device incorporates key advancements including the use of the Polyglycolic Acid Plug, two visual indicators to moderate control of the device and lockout features to reduce the risk of complications. The device is designed for ease of use, reducing the number of components and deployment steps.

The ExoSeal™ Vascular Closure Device is due to be available for the commercial market in June in Europe. Alongside the ExoSeal™ Vascular Closure Device launch, Cordis will roll out a comprehensive programme of customer training and certification to ensure that all users are fully confident in the handling of the device.

“From our experience in the ECLIPSE trial, we were impressed with the safety and the effectiveness of this new closure device. It is very easy to use and nothing is left inside the vessel to threaten arterial blood flow, explains Marcus Wiemer, M.D., Primary Investigator, Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, in Bad Oeynhausen, Germany*.

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“An advantage compared to other devices is the procedural sheath does not need to be changed which helps promote patient comfort. The two visual indicators are important for positioning the bioabsorbable plug ” .

The Eclipse Trial

The safety and effectiveness of the device was assessed in two non-randomized studies conducted in Mexico and Germany, as well as a study in the US where the 6F ExoSeal™ was compared with manual compression (MC) with a 2:1 randomisation in patients undergoing diagnostic and interventional coronary/peripheral procedures. The trials tested the time to hemostasis, the time to ambulation and the 30-day combined rate of access site-related complications. The results showed that there were no major adverse events, no vascular repair, no access site-related bleeding requiring transfusion, no access site-related infection requiring treatment, no new ipsilateral low extremity ischemia and no surgery for access site-related nerve injury.