December 22, 2011 — TriVascular Inc. announced the first Canadian patients treated with its Ovation Abdominal Stent Graft. The ultra-low profile (14F OD) system is designed to expand the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomy. Cherrie Abraham, M.D., vascular surgery, McGill University, performed the first case in Canada at Montreal Jewish General Hospital (JGH). The second case, also performed at JGH, was performed by Daniel Obrand, M.D., chief of vascular surgery, JGH.
"The Ovation abdominal stent graft performed very well in the two cases completed here," said Abraham. "We are pleased to be in a position to offer this technology to patients that would otherwise not have a viable treatment option for their abdominal aortic aneurysms. The significantly reduced profile of the delivery catheter will increase the pool of patients to whom we can offer EVAR. This was our first aneurysm patient that has gone home on the same day as his surgery and may be the start of a new paradigm in vascular surgery: same day surgery for abdominal aortic aneurysm repair for select patients. I think the low profile grafts give us the confidence to send patients home sooner."
The device is available in Canada under Health Canada's Special Access Program (SAP). The program allows doctors to gain access to medical devices in emergency use cases or when conventional therapies have failed, are unavailable, or are unsuitable to treat a patient.
Ovation has been used to treat more than 500 patients worldwide. The device is approved for use by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). In Europe, it is CE marked and is used to treat a broad range of patients with abdominal aortic aneurysms.
For more information: www.trivascular.com