New trial results on ExoSeal support its clinical safety and efficacy
Published date : 01 June 2010
Article date : 01 June 2010
The new ExoSeal vascular closure device (Cordis) received CE mark in May 2010 and was recently launched at the EuroPCR meeting in Paris. The company states that it incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure. The new product was shown in a recent clinical trial to have an “excellent” clinical safety profile (in terms of vessel injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischaemia or serious adverse events [SAE]) during vascular procedures.
The ExoSeal device makes use of key technological developments to support the clinical safety of the closure procedure. The bioabsorbable polyglycolic acid (PGA)-plug, is fully reabsorbed in 60–90 days. According to Cordis, a system of deployment through the existing procedural sheath makes ExoSeal quicker and easier to use and increases physician convenience by minimising 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 helps ensure that only extra-vascular plug placement can take place.
ECLIPSE Trial
The safety and effectiveness of the ExoSeal was assessed in two non-randomised 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 haemostasis, 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 ischaemia and no surgery for access site-related nerve injury.
The 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.
