Last November we announced that California-based company TriVascular had gained FDA clearance to supply its Ovation EndoGraft on a Humanitarian Device Exemption basis. Now the agency has issued Consumer Information about the system.
FDA grants Humanitarian Device Exemption(HUD) approval for products, the applicable target audience for which is under 4000 per year, yet representing a patient group where such a device would provide a potentially life-saving option. In November 2011 we covered TriVascular’s announcement that it had gained HUD approval for its endovascular aneurysm repair device intended for use specifically in patients for whom endovascular repair (EVAR) is an option, but who have smaller access vessels and small aortic anatomy.
The 20-mm Ovation system differs from traditional endografts in that a portion of the metal stent is replaced with ring-shaped channels. After the device is in place in the aorta, the channels are injected with a polymer, expanding the endograft against the aorta to create a seal.
FDA’s information can be found here.
According to the product’s instructions for use, the Ovation Abdominal Stent Graft System is indicated for use in subjects diagnosed with an aneurysm in the abdominal aorta with small aortic diameters and access vessels of less than 7 mm in diameter, having vascular morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories; a non-aneurysmal proximal aortic neck with a length of at least 7 mm proximal to the aneurysm, with an inner wall diameter of no less than 15.5 mm and no greater than 17.4 mm, and with an aortic angle of <= 60 degrees if proximal neck is > 10 mm and < 45 degrees if proximal neck is < 10 mm; adequate distal iliac landing zone with a length of at least 10 mm, with an inner wall diameter of no less than 8 mm and no greater than 17 mm.
Source: FDA, TriVascular Inc