TriVascular Technologies (Santa Rosa, CA) won FDA approval for the CustomSeal Technology that’s used in placing the company’s Ovation stent grafts to treat abdominal aortic aneurysms (AAA). The special polymer O-ring on the neck of the stent sits within the aorta, but does not apply continuous pressure against the vessel’s walls to maintain a leak-proof seal.
In order to achieve this, after the delivery of the main part of the stent the O-ring is filled with a polymer to match the patient’s aorta. Once cured, a process that’s now 30% faster that’s to the customized polymer delivery, the rest of the stent graft can be deployed.
Here’s an animation demonstrating the Ovation Prime implantation procedure:
Flashbacks: TriVascular Ovation Prime Stent for AAA Gets U.S. Clearance…; TriVascular Ovation Abdominal Stent Graft System Receives Humanitarian Device Exemption…; TriVascular’s Ovation AAA Stent Gets Green Light in EU…
Info page: CustomSeal Technology…
Press release: TriVascular Announces FDA Approval of CustomSeal(TM) Technology for the Ovation Prime(R) System…