PARIS, May 27, 2010 /PRNewswire/ --
- New Trial Results on ExoSeal(TM) Vascular Closure Device Support its ClinicalSafety* and Efficacy
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
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.
Notes to editors:
About the ExoSeal(TM) Vascular Closure Device:
The ExoSeal(TM) Vascular Closure Device is due to be available for the commercial market in June in Europe. Alongside the ExoSeal(TM) 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.
About 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(TM) 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.
* Clinical data from the ECLIPSE trial indicates safety in terms of vessel injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischemia or serious adverse events (SAE). ** In addition to his role as Primary Investigator, Dr. Weimer is compensated for his services as a member of the Company's scientific advisory board and provides other consulting services.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has been a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.
SOURCE Cordis Corporation
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