Suture-Tight™ First-in-Human Safety and Performance Study (Suture-Tight™)

Single center, open label, prospective, single-arm, first-in-human (FIH), pre-market clinical study with the objective of validating the safety and performance of the Suture-Tight™ Suture Delivery System in an EVAR procedure.

Single center, study conducted at the Prince of Wales Private Hospital in Randwick, Australia. Up to 6 subjects may be enrolled. 1 to 3 subjects will complete initial enrollment and be followed for 30-days evaluating procedure and device safety. Additional subjects may be enrolled following the safety review to complete the 6-subject study. All subjects will be followed for six (6) months. Subjects meeting all inclusion and exclusion criteria will be consented to receive an elective endovascular aortic aneurysm repair (EVAR) with graft anchoring utilizing the Suture-Tight device. Procedure and device safety and performance will be evaluated at 1- and 6-months by completing CT scans and KUB x-rays. Data may be used to support a pivotal study of the investigational device and future global regulatory submissions.

Subjects meeting all inclusion and exclusion criteria will receive graft anchoring utilizing the Suture-Tight Suture Delivery System.

Implantation of the Suture-Tight Suture in the deployment of multiple nitinol sutures to provide augmented fixation and sealing between endovascular aortic graft and the native artery.

Recording of all Serious Adverse Event (SAE) related to the Suture-Tight™ Suture Delivery System procedure or device

Documentation of Procedural success defined as: Successful delivery of the Suture-Tight™ Delivery Catheter to the site of intended treatment Successful removal of Suture-Tight™ Delivery Catheter Absence of evidence of acute endograft migration or dysfunction at the conclusion of the procedure Absence of a Type 1a Endo Leak Absence of a stent graft migration

Evaluation of Changes in Stent graft patency, migration or displacement in follow-up as measured by an abdominal CT scan

Evaluation of the Suture-Tight™ Suture migration, displacement, or fracture as measured by an abdominal CT scan and KUB x-rays.

Inclusion Criteria: Currently scheduled for an elective endovascular repair of an abdominal aortic aneurysm (AAA) by EVAR with CT scan from within last 4 months. Acceptable AAA parameters include: AAA ≥ 5.5 cm in diameter (men) or ≥ 5.0 cm in diameter (women) OR AAA ≥ 4.5 cm in diameter with an increase of ≥ 0.5 cm within the past 6-months or ≥ 1.0 cm over the past 12-months Neck diameter, length and angulation that meets labeling requirements for the endograft used Successful EVAR graft placement with no evidence of EVAR-associated serious adverse event. Exclusion Criteria: Mycotic or inflammatory AAA Prior surgical repair of an AAA Renal dialysis or significant chronic renal failure Evidence of recent acute coronary disease, thrombotic disease, or cerebral infarct Pregnancy