The main phase of the trial, which planned to enroll up to 150 patients with high-angle aortic necks, has also finished, but those data are not yet publicly available. Lombard Medical, the company developing this device, submitted the main-phase data to the FDA, and should make the results public in the next 6 months, he said.
• Prefenestrations. Perhaps one of the more exciting new devices is the Ventana fenestrated system, an "off-the-shelf" device that comes with prefenestrations for the renal arteries that precludes the need for a custom-made device.
Dr. Daniel Clair
A current "unmet clinical need" for EVAR is a device to address patients with a short or nonexistent infrarenal neck, something that occurs in about a quarter of abdominal aortic aneurysm patients, said Dr. Daniel Clair, professor and chairman of vascular surgery at the Cleveland Clinic.
The system can potentially treat even aneurysms that include the renal arteries. The material used in the device is a multilayer polytetrafluoroethylene that forms small branches at the fenestrations that reach out into the renal arteries, and the device is delivered in a 22-Fr sheath.
Pilot studies used this system successfully on 15 patients outside the United States last year, and in February the next phase starts with another 30-50 patients scheduled for treatment both in and outside the United States, he said.
The pivotal U.S. trial (with 122 patients scheduled for treatment) also starts this year, with Dr. Clair as the principal investigator.
• Aneurysm sealing. Also in development is an EVAR-like device that’s not a stent. The Nellix system seals an aneurysm endovascularly, by deploying bags that fill with a liquid polymer that quickly solidifies to seal an aneurysm sac around a pair of stents. The system delivers the polymer at greater than blood pressure to extrude all blood from the aneurysm sac, said Dr. Lindsay Machan, a vascular surgeon at the University of British Columbia in Vancouver. This facilitates treatment of aortas with short or severely angulated necks. "The polymer anchors the devise at the bifurcation," Dr. Machan said, producing "remarkable" stability, better than devices that rely on barbs for anchoring.
So far, operators have used the Nellix system in 47 patients in New Zealand and Latvia, the first 31 with a first-generation device and, more recently, the remaining 16 patients with a second-generation version. More than 1 year of follow-up exists for 34 patients. These cases had 100% technical success with no ruptures, no conversions to open repair, and no endoleaks (either persistent or type II), he said. Two patients needed a secondary procedure, one for renal insufficiency, the other for a type I endoleak after 15 months.
The pivotal U.S. trial is planned to start later this year. "This ‘out-of-the-box’ technology addresses many shortcomings of EVAR, and uses a simple insertion procedure that takes 20-30 minutes," Dr. Machan said.
Dr. Böckler said that he has financial relationships with W.L. Gore, Medtronic, VASCOPS, and Siemens. Dr. Sievert said that he has financial relationships with TriVascular, W.L. Gore, and 55 other device companies. Dr. Greenberg said that he has an ownership interest in Cook Medical. Dr. Bersin said that he has financial relationships with Cordis Endovascular, W.L. Gore, Cook, and Bard. Dr. Gray said that he is a consultant to Cordis. Dr. Clair said that he has financial relationships with Endologix, ev3, Medtronic, Boston Scientific, and Covidien. Dr. Machan said that he has financial relationships with Boston Scientific, Cook, Calgary Scientific, Endologix, and Ikomed.