New Trial Results on ExoSeal(TM) Vascular Closure Device Support its Clinical Safety* and Efficacy
PARIS, May 27, 2010 /PRNewswire/ -- Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced the launch of the ExoSeal(TM) Vascular Closure Device. ExoSeal(TM) incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure. Cordis Corporation received CE-Marking approval for ExoSeal(TM) Vascular Closure Device in May 2010. This new product was launched during EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
ExoSeal(TM) was shown in a recent clinical trial to have an excellent clinical safety* profile during vascular procedures. 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.
"We are very pleased to announce the launch of our first Vascular Closure Device" said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation. "The ExoSeal(TM) 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."
"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. 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 ," explains Marcus Wiemer, M.D., Primary Investigator, Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, in Bad Oeynhausen, Germany**.
ExoSeal(TM) in detail
The ExoSeal(TM) Vascular Closure Device makes use of key technological developments to support the clinical safety of the closure procedure. In the ECLIPSE Trial, the extravascular plug placement was associated with no embolization, infection or other major adverse events, comparable to manual compression [despite the significantly shorter time to ambulation for ExoSeal(TM)]. The bioabsorbable PGA-plug, which is designed to close the femoral artery puncture site with minimal or no inflammation, is fully reabsorbed in 60-90 days. PGA (Polyglycolic Acid) is a trusted non-collagen plug material that is metabolized to carbon dioxide and water. A system of deployment through the existing procedural sheath makes ExoSeal(TM) quicker and easier to use and increases physician convenience by minimizing or eliminating the need for sheath exchange during the procedure. The device uses visual indicators to help the clinician deploy the device correctly. This "visual feedback" also promotes patient comfort during deployment and the 'lock-out' system of ExoSeal(TM) helps ensure that only extra-vascular plug placement can take place.