TriVascular announced on 6 August 2013 approval from Health Canada of the Ovation Abdominal Stent Graft System. The ultra-low profile system, with novel O-ring sealing technology, expands the patient population suitable for endovascular aortic repair (EVAR) by addressing a wider range of diseased anatomy, according to the company. Delivered through a 14F (4.7mm) outer diameter catheter, the Ovation device is the lowest profile commercially available system for EVAR. In a 161-patient, global clinical study, the Ovation system demonstrated excellent safety and effectiveness results.
Prior to Health Canada approval, the Ovation Abdominal Stent Graft System was used to treat 20 patients in Canada under Health Canada’s Special Access Program. The Ovation system received premarket approval from the US Food and Drug Administration (FDA) in October 2012. TriVascular has been actively marketing the Ovation system in Europe since late 2010. Since initiating a first-in-man clinical study with the Ovation Abdominal Stent Graft System in late 2009, TriVascular has treated over 2,000 patients worldwide.
“I believe the Ovation Abdominal Stent graft system is an important addition to our clinical toolkit. The combination of a novel sealing technology with a low profile delivery system allows us to safely expand the pool of patients to whom we can offer EVAR,” commented Randolph P Guzman, head and professor of Surgery, Section of Vascular Surgery, University of Manitoba. Canada. His team recently performed the first post-approval cases in Canada at St Boniface Hospital in Winnipeg. “Our experience to date is encouraging and we look forward to broader use now that Health Canada has approved the Ovation system,” said Guzman.
“We believe aneurysm access advantages enabled by our low profile system, combined with our unique O-Ring sealing technology will enable Canadian physicians to offer this clinically proven therapy to many patients who were previously ineligible for EVAR” said Christopher G Chavez, chairman, CEO and president of TriVascular. “We are excited about the approval of the Ovation system in Canada and look forward to partnering with Canadian physicians to expand patient access to EVAR.”
TriVascular has signed an exclusive distribution agreement with Inter V Medical, a Montreal-based Canadian medical products distributor, to commercialise the Ovation Abdominal Stent Graft in Canada. “This partnership is a natural fit between the companies. For over 20 years, Inter V Medical has been proud to provide the Canadian interventional specialties market with the latest innovative technology like the Ovation Abdominal Stent Graft,” said Geneviève Bedard, president of Inter V Medical.