Tenaxis Medical, a developer of sealants for use in vascular and general surgery, has completed patient enrollment in its pivotal US study for the ArterX Vascular Sealant. The study was designed to enroll up to 220 patients who were scheduled to receive a synthetic vascular graft or patch at 12 investigational sites within the US.
Typical applications involved the placement of arteriovenous dialysis access grafts, carotid endarterectomy patches and large vessel reconstruction, such as the open repair of abdominal aortic aneurysms.
The company claims that ArterX was compared to a thrombin-soaked gelatin-sponge hemostat in a superiority study, to reduce or eliminate suture line bleeding.
Ronald Dieck, president and chief executive officer of Tenaxis Medical, said: “Completion of the enrollment phase of the study is a key milestone in the development of Tenaxis Medical. We look forward to submitting our PMA to the FDA in the next few months.”
California-based Tenaxis Medical is engaged in the development of sealants for use in vascular and general surgery. In addition to the ArterX vascular Sealant, the company is developing a second high performance sealant for use throughout the gastrointestinal tract, and an anti-adhesion agent that can be delivered laparoscopically to prevent pelvic and abdominal adhesions.