Santa Rosa, CA (PRWEB) August 03, 2011
TriVascular, Inc. today announced the initiation of a Phase 3 (Continued Access) trial of the Ovation™ Abdominal Stent Graft System in the United States. This protocol will allow the 28 US sites involved in the pivotal Ovation Abdominal Stent Graft Trial to continue treating patients who meet the study criteria.
“We are thrilled to be able to continue enrolling patients in the US, both to continue making the Ovation Abdominal Stent Graft available to our clinical investigators and to further expand the body of clinical experience with our device,” said Michael Chobotov, Ph.D., President and CEO of TriVascular, Inc. “This program is intended to complement our already enrolled 161 patient global pivotal trial and recently initiated 500 patient European Post Market Registry, resulting in a robust collection of clinical experience to support our device.”
The first patient was enrolled in the Continued Access trial by Dr. William Jordan, Professor and Chief of Vascular Surgery at UAB Medical Center in Birmingham, AL. Dr. Jordan noted, “By combining a unique sealing mechanism with an extremely low profile, 14F OD delivery system, Ovation has the potential to expand treatment options and improve patient outcomes for patients undergoing treatment for AAA.”
With a 14F OD, Ovation is the lowest profile AAA system undergoing clinical study in the United States. The innovative, low profile system separates and optimizes the two most important elements of EVAR, fixation and seal, and is designed to expand the pool of treatable patients by addressing a wider range of diseased anatomy.
Ovation received CE Mark Clearance in August 2010, and officially launched in Europe in January 2011. Enrollment in the pivotal study of the Ovation Abdominal Stent Graft concluded in March 2011. A European Post Market Registry, designed to treat 500 patients, was initiated in June 2011.
About TriVascular, Inc. - TriVascular’s initial product offerings are novel endovascular grafts focused on significantly advancing EVAR. Building upon partnerships with thought leading clinicians worldwide, TriVascular’s products are designed to address unmet clinical needs and expand the pool of patients who are candidates for EVAR. Based in Santa Rosa, California, TriVascular offers highly talented, motivated individuals the opportunity to positively impact global healthcare.