The first human use and successful abdominal aortic aneurysm (AAA) repairs using Aptus Endosystems’ Aptus AAA Repair System, including the novel endovascular stapling system, have been performed at the Hospital Centro M©dico de Caracas in Caracas, Venezuela.
The procedures were performed by Dr Takao Ohki, Professor and Chief of Vascular Surgery, Montefiore Medical Center, Bronx, New York, Dr David Deaton, Chief, Endovascular Surgery, Georgetown University, Washington DC, and Dr Jos© Antonio Condado, Director, Interventional Cardiology at the Hospital Centro M©dico de Caracas in Caracas, Venezuela.
Ohki commented, “The Aptus AAA Repair System was very easy to use. The delivery and deployment of the endograft was straightforward. Staple deployment was simple and extremely precise despite the fact that the aneurysm, in one of the patients we treated, had a very angulated and short proximal neck. The endostapling process adds very little extra time to the procedure while providing maximum fixation.”
The Aptus AAA repair system consists of a highly conformable endograft, which is deployed from a low profile delivery catheter and a unique endovascular stapler for securely attaching the endograft to the artery wall. The use of endovascular staples is designed to replace the need for barbs and/or trans-renal stents, while enabling the treatment of short and angulated proximal necks.
“The Aptus AAA Repair System represents a new era in endovascular technology. It is the first system that includes endovascular stapling, which will revolutionize endovascular procedures,” said Deaton. “We were able to successfully treat an acute Type I endoleak with the endovascular staples, a world’s first. This represents a new level of control, precision and security in all future endovascular procedures”.
Dr Alan Kaganov, President and CEO of Aptus said that the company was very encouraged by the positive results of these first clinical procedures and is proceeding towards an IDE submission in the US, hoping to start clinical trials in early 2006.