Closure Receives CE Mark for OMNEX

Closure Medical has received the European Union's CE Mark approval for its proprietary OMNEX Surgical Sealant, the company's first product indicated for use inside the body.

OMNEX sealant is a synthetic, biodegradable material that mechanically seals the surfaces of blood vessels and artificial grafts to prevent blood leakage after traditional suturing. The product's clinical application under the CE Mark allows for its use as an adjunct to sutures to achieve hemostasis in peripheral vascular reconstructions, including when bypassing an occluded blood vessel or creating a shunt for hemodialysis access in diabetic patients.

Closure plans to seek approval for OMNEX sealant from the FDA in 2005. The company has completed the enrollment phase of its 150-patient pivotal study for OMNEX sealant, which assessed the ability of the sealant to prevent leakage following reconstruction of vascular structures in patients receiving femoral bypass or arteriovenous shunt procedures for hemodialysis access.