Aptus Endosystems has received CE Mark approval for its Aptus EndoStapling System for use in endovascular aneurysm repair (EVAR) procedures. EVAR procedures are performed to treat abdominal aortic aneurysms and are performed more and more often instead of open surgical repair. Proximally, the stent is fixated to the aortic wall to avoid migration and endoleaks. During open procedures, this is done by meticulously suturing, however during endovascular procedures only the stent’s self-fixating property prevents these complications.
The EndoStapling System uses a helical staple technology for independent endograft fixation, mimicking the hand suturing performed during open surgical repair. It can be used to repair endovascular grafts that have migrated or exhibit endoleaks, by strengthening the radial fixation and/or sealing to regain or maintain effective aortic aneurysm exclusion. It can also be used at the time of initial endograft implantation to enhance an endograft’s inherent fixation and sealing mechanisms. From the press release:
“The use of the Aptus EndoStapling system will be a great advantage to simplify revision surgery for migrated endografts,” said Jean Paul de Vries, M.D., Ph.D., Head of the Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands. “The ability to staple migrated endografts to the aortic wall and to fixate extension cuffs will overcome most migrations and type IA endoleaks. This system truly mimics a sutured anastomosis.” In addition, de Vries said, “EndoStaples can improve fixation of de novo endografts in challenging proximal necks – short, large and angulated – and can potentially reduce distal migration during follow-up.”
Aptus Endosystems CEO Jeff Elkins called the CE Mark approval a “significant milestone.” He went on to comment that, “Given the recent publication of several long term EVAR outcome studies, we now recognize that late EVAR failure and the need for secondary intervention is a major underserved clinical need affecting many patients, and continued improvement in technology is required. To date, physicians have had limited prophylactic and treatment options for graft migration and Type I endoleaks. The novel concept of independent and physician controlled proximal fixation using the EndoStapling System is a considerable step toward addressing long term complications and making EVAR a more definitive solution for treating aortic aneurysms.”
The EndoStapling system is approved for use with Aptus’ own endograft and with the Cook Zenith, Gore Excluder, and Medtronic AneuRx, Endurant, and Talent endografts in both initial implant and secondary repair settings. In an initial phase I trial with 21 patients, no device migration and no Type I, III, or IV endoleaks were detected one year after implantation. A larger follow-up trial with 155 patients is currently underway, of which we anxiously await the results.