Cordis, a Johnson & Johnson company, has said its EXOSEAL Vascular Closure Device has received the US Food and Drug Administration (FDA) approval in the US.
The safety and effectiveness of EXOSEAL was assessed in the ECLIPSE trial where it was compared with manual compression (MC) with a 2:1 randomization in patients undergoing diagnostic and interventional coronary/peripheral procedures.
The trial tested the time to hemostasis, the time to ambulation and the 30-day combined rate of access site-related complications.
Primary investigator S Chiu Wong said the use of EXOSEAL significantly reduced time to ambulation compared to MC.
"There were no major adverse events, no vascular repair, no access site-related bleeding requiring transfusion and no access site-related infection requiring treatment," Wong said.
Another primary investigator William Bachinsky said the EXOSEAL device’s two visual indicators and lockout features provide additional measures to help ensure precise extravascular placement.
"Because of the design there is minimal tugging and pulling required which could help to improve patient comfort during closure," Bachinsky said.
Cordis CSO and R&D global head Campbell Rogers said they are looking forward to building upon the experience that clinicians and patients have had outside the US since June 2010 when EXOSEAL received CE mark in Europe.
The device has been available in Europe, Asia and Latin American markets since June, 2010.
It is due to be available to the commercial market in June in the US.