Ethicon, a provider of surgical care medical devices, has introduced Omnex Surgical Sealant to achieve adjunctive hemostasis in vascular reconstructions by mechanically sealing areas of leakage. The FDA had recently granted approval of the premarket approval application (PMA) for Ethicon Omnex Surgical Sealant.
Ethicon claimed that the Omnex Surgical Sealant decreases time to hemostasis and offers improved strength to other surgical sealants and creates a flexible physical seal independent of the body’s clotting mechanisms.
The Omnex Surgical Sealant is said to have proven efficacy in a broad spectrum of vascular reconstructive procedures including arteriovenous access, aortobifemoral bypass, femoral popliteal bypass, endarterectomy, abdominal aortic aneurysm and aortotomies.
The Omnex Surgical Sealant is contraindicated in patients with known hypersensitivity to cyanoacrylate or formaldehyde. The device is not for intravascular use. Ethicon said that the sealant is intended for use as an adjunctive and is not to be used in place of sutures, staples, or mechanical closure.
Alan Lumsden, MD of the Methodist DeBakey Heart and Vascular Center and chairman of the department of cardiovascular surgery at The Methodist Hospital in Houston, said: “A basic rule of patient safety and excellent outcomes is to prevent unnecessary bleeding during and immediately after surgery.
“The availability of an effective surgical sealant such as Ethicon Omnex provides surgeons with a valuable new tool that is clinically proven to decrease the time it takes to seal the surgical site, including ePTFE grafts, and prevent leakage from occurring.”