During the International Congress in Phoenix, AZ, Dr Takao Ohki, Montefiore Medical Center, NY, presented his first-in-man experience with the Aptus endostapler device (Aptus Endosystems).
Ohki began by stating that there needs to be honesty when it come to migration: “Every graft migrates, especially if they are used outside the IFU, even with suprarenal stent and barbs, although less frequently, but the migration rate is certainly not 0% in a ‘real-world’ setting.”
As well as migration, he said that another problem with current endografts is that once you put the stent inside the main body, you get a friction that leads to fabric wear. To combat these events, the Aptus Modular Endograft was designed to replace the need for barbs and/or trans-renal stents, while enabling the treatment of short and angulated proximal necks.
This incorporated the use of a short stent for the purpose of delivery and sealing. The deployment system is a low profile 16F sheath, which is possible as the fabric insertion is separate from the fixation mechanism. The graft remains connected to the delivery system until all the endostaplers have been used.
The steerable guide allows physicians to direct the endostapler to the desired position by rotating the handle. The endostapler has a failsafe mechanism that allows the user to ‘fire’ halfway through the procedure to check for tissue purchase – if not we can retrieve it, Ohki commented.
The first human cases and successful abdominal aortic aneurysm (AAA) repairs using the Aptus Endosystems’ Aptus AAA Repair System were performed in July 2005, at the Hospital Centro M©dico de Caracas in Caracas, Venezuela. The procedures were performed by Ohki and Drs David Deaton, Chief, Endovascular Surgery, Georgetown University, Washington DC, and Jos© Antonio Condado, Director, Interventional Cardiology at the Hospital Centro M©dico de Caracas in Caracas, Venezuela. The first two procedures took a mean time of 2 hours 19 minutes, “Not bad for a first in man and considering no-one spoke English,” added Ohki. He believes that this system can be used in severely angulated necks due to the lack of robust stents.
In a comparison of current endovascular grafts and the Aptus system, Ohki said that migration would still continue to be an issue with current grafts, whereas the Aptus system provides physicians with a surgical-grade fixation. In addition, as there is no stent body in the Aptus graft, there is no occurrence of stent-fabric interaction (fabric-wear) seen with current systems.
In conclusion, Ohki said the Aptus system was safe and easy to use. The stapler can be applied readily at the desired location and be used for fixation and sealing purposes.
The company is starting Phase I clinical trials in the second quarter of 2006 and hopes to begin a Pivotal study in 2007.