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Aug4TriVascular Technologies, Inc. Receives FDA Approval of the Ovation iX(TM) Abdominal Stent Graft System


Next Generation Aortic Body Delivery System Approval Continues Strong Cadence of New Product Introductions 

 

Santa Rosa, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (NASDAQ:TRIV) announced today that the U.S. Food and Drug Administration (FDA) approved the Ovation iX Abdominal Stent Graft System. Delivery system enhancements of Ovation iX, which stands for integrated exchange, are designed to provide physicians with additional flexibility for even more predictable deployment and greater ease of use. A new, built-in procedural option is available to replace retrograde cannulation of the main body device, facilitating placement of the contralateral iliac stent graft. A low profile, 12-13F integrated sheath is designed to minimize vessel trauma and reduce procedural steps. At 14F OD, the Ovation iX abdominal stent graft system remains the lowest profile FDA-approved EVAR device.

 

"The improvements reflected in the new Ovation iX aortic body set the Ovation® system even further ahead in terms of ease of use and predictability of deployment. This allows me to treat both straightforward and more challenging AAA anatomies with confidence," commented Dr. Steve Henao, Vascular Surgeon at New Mexico Heart Institute. "By providing an alternative to retrograde cannulation - there when I need it, imperceptible when I don't - the Ovation iX system offers not only excellent accuracy, but also procedural predictability. As a result, I am confident in my ability to offer my patients consistent, high quality clinical outcomes with the Ovation system."

 

The FDA approval of the Ovation iX Abdominal Stent Graft System marks the sixth FDA approval related to the Ovation platform since September 2011. This demonstrates TriVascular's ongoing commitment to quickly providing physicians with clinically useful products. The ease-of-use enhancements incorporated into the iX aortic body delivery system, as well as the recently approved iX iliac limb technology, are a direct result of physician input and indicative of TriVascular's responsiveness to clinical feedback.

 

"The launch of the complete Ovation iX system supports our mission to improve and safely expand EVAR for all and serves as evidence of our commitment to deliver a strong pipeline of products," said Christopher G. Chavez, Chairman, CEO and President of TriVascular. "We believe the Ovation iX delivery system enhancements will complement the broad IFU of the Ovation system and further enable our physician partners to provide improved, on-label EVAR treatment to more patients."

 

The Ovation platform has been used in the successful treatment of over 7,000 patients worldwide. Excellent clinical results have been reported from both the Ovation global pivotal trial and a 501-patient European Post-Market Registry. The Ovation platform is available for sale in over 35 countries.

 

About TriVascular Technologies, Inc.  

 

TriVascular is a medical device company developing and commercializing innovative technologies to significantly advance minimally invasive treatment of abdominal aortic aneurysms. The company manufactures the Ovation Abdominal Stent Graft platform, the lowest profile FDA-approved EVAR system, which utilizes a novel, polymer-based sealing mechanism. TriVascular is based in Santa Rosa, California.

 

Forward-Looking Statements

 

In addition to the historical information, this press release contains forward-looking statements with respect to our business, the Ovation system, our stent graft technology and our ability to expand EVAR treatment option to a broader population of patients with AAA disease. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; continued market acceptance of our endovascular aortic repair systems; our ability to manufacture our endovascular systems to meet demand; the level and availability of third party payor reimbursement for our products, our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; our ability to develop new or complementary technologies; the regulatory requirements applicable to us and our competitors; competition in our industry; additional capital and credit availability, our ability to attract and retain qualified personnel; product liability claims; and general economic and worldwide business conditions. These factors, together with those that are described in greater detail in our Annual Report on Form 10-K filed with the SEC on March 9, 2015 and our other filings with the SEC, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

 

CONTACT:

 

Company Contact:

TriVascular Technologies, Inc.

Michael Kramer

Chief Financial Officer

707-543-8709

mkramer@trivascular.com

 

Media Contact:

TriVascular Technologies, Inc.

Vivek K. Jayaraman

VP, Global Sales & Marketing

707-543-8804

 

Investor Relations Contact:

Westwicke Partners

Jamar Ismail

415-513-1280

jamar.ismail@westwicke.com