![]() Radiopaque markers are affixed to the device to facilitate fluoroscopic positioning. The endograft is constructed of a seamless, low-porosity, woven polyester fabric tube, supported by a series of electropolished, laser-cut, self-expanding nitinol stent rings along its entire length, each sutured to the inner surface of the graft material. If distal extension is desired, additional iliac limb prostheses can be deployed. The device is typically assembled from the three components: the aortic bifurcate prosthesis main body and the two iliac limb prostheses. The INCRAFT AAA Stent graft System is a trimodular (one aortic bifurcate prosthesis main body and two iliac limb prostheses), bifurcated, endovascular graft ( Fig 1) that is preloaded into a delivery system. The study was conducted in accordance with the International Conference on Harmonization Guidelines, Good Clinical Practices, Declaration of Helsinki, ISO 14155-1, ISO 14155-2, and ethics committee requirements, and all patients gave written informed consent prior to participation. The trial was registered on (NCT01106391) and Competent Authority approval was obtained. Between March and June 2011, 35 additional patients were enrolled in the second phase of the trial. To comply with regulatory requests for a larger sample size, the protocol was revised to increase the study to 60 patients, and three Italian sites were added. ![]() The first phase of the trial included 25 patients at three German sites, enrolled between March and November 2010. The INNOVATION study (multicenter, open-label, prospective, nonrandomized study of INCRAFT in subjects with AAAs) is a multicenter, prospective, nonrandomized evaluation of the first in-human experience with the INCRAFT device. ![]() No limb thromboses or stent fractures were noted on postoperative imaging studies and no patient required rehospitalization, a secondary procedure, or open surgical conversion through 1 month of follow-up. There were no type III or IV endoleaks and no device or procedure-related major adverse events at 1 month. The primary safety end point was met in 56 of the 58 patients (97%) with complete core laboratory data at 1 month two patients had type I endoleaks. Technical success was achieved in 54 patients (90%) one patient had a type I endoleak, four had type IV endoleaks, and one had an endoleak of undetermined origin. A single patient had successful deployment of the device although it was located more distally than planned. Successful graft deployment at the desired location was achieved in 59 patients (98%). A percutaneous approach was used in 36 patients (60%). Over a 16-month period divided into two different phases, 57 men and three women with a mean age of 74.4 ± 6.9 years were enrolled at three German and three Italian centers. Journal of Vascular Surgery Cases, Innovations and Techniques.Journal of Vascular Surgery: Venous and Lymphatic.We also offer this same custom chimney cap with mesh in 8 inch, 10 inch, and 12 inch height to fit almost everyone's needs. This item comes in widths of 9 inches to 28 inches, and lengths of 9 inches to 58 inches, with a 16 inch mesh height. And we mean your needs - semi-custom means that you get to choose the length, height, mesh size and and overhang for yourself. This Gelco semi-custom, multi-flue chimney cap is built to take care of exactly your needs. But if you've got a chimney with multiple flues, it should be a bit more complicated, shouldn't it? Not here. Just a simple metal cage, sitting on top of your flue, that keep the rain and animals out, while the wire mesh lets smoke out and keep sparks in. Here's the thing, though - chimney caps help prevent all of those problems. Unless it's paying for water damage in your chimney, or having a wayward spark from your fireplace catching your roof on fire. *Please Note: This item is custom made by the manufacturer and can not be cancelled or returned once the order is placed unless the item is defective or damaged in transit.įew things in life are less fun than dealing with an unwanted animal visitor in your home. ![]() *Also Note: GSC Lids are embossed if the width is 14” or greater but lids that are 13” and less width have no embossing. * Please Note: These chimney caps are made to order and cannot be returned once purchased. Comes with both standard bolts and washers for easy installation.Trimmed-off screen barbs to protect the installer's hands.Cross-braced for additional structural strength.Durable stainless steel construction resists weather.Options of 3/4" mesh or 5/8" mesh (California compliant) for stricter spark protection. ![]()
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