Tenaxis Medical, Inc. Announces Completion of the Enrollment Phase of Their Pivotal Study
MOUNTAIN VIEW, Calif., Jan. 25 /PRNewswire/ — Tenaxis Medical has completed enrollment of its pivotal US study for the ArterX Vascular Sealant(TM). 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.
ArterX was compared to a thrombin soaked gelatin-sponge hemostat in a superiority study to reduce or eliminate suture line bleeding. President & Chief Executive Officer, Ronald Dieck commented, “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.”
About Tenaxis Medical, Inc.
Incorporated in 2004 and located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company. It develops novel, high performance 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.
CONTACT: Cindy Carter of Tenaxis Medical, Inc., +1-650-691-9016, Ext. 101, firstname.lastname@example.org
SOURCE Tenaxis Medical, Inc.