Endovascular Suturing Device for Augmentation of Endograft Fixation During Endovascular Repair of Abdominal Aortic Aneurysm to Reduce Reinterventions Due to Endograft Migration or Type 1a Endoleak

PROJECT SUMMARY Abdominal Aortic Aneurysm (AAA) is diagnosed in over 200,000 Americans each year. Large AAAs are treated with stented grafts using an open surgical repair (OSR) procedure or with a less invasive endovascular repair technique (EVAR). Under current practice guidelines, 80% of patients are treated with EVAR because of the greater peri-operative mortality associated with OSR (5%). However, current practice is being challenged by the mounting evidence of long-term endograft durability following EVAR. Roughly 20% of EVAR patients require reintervention at 5 years, and 30% at 10 years; 10 year mortality has been found to be worse following EVAR compared to OSR. The cause of EVAR failure is graft migration over time. The solution is to secure the proximal cuff (the top portion) of the endograft to the aorta immediately below the renal arteries, a solution that has been validated by a currently marketed device. While this device has established the feasibility of EVAR endograft anchoring, it uses a technique that has been found to be difficult to use with high failure rates. Vesteck has developed and established the feasibility of a device that utilizes novel and proprietary technology to address both the problem of long term EVAR durability and the problems associated with the currently marketed endoanchoring device. Preliminary pre-clinical V&V testing of the Vesteck device was completed in 2022 to support First-in-Human early feasibility studies. To date, 14 patients have been successfully treated without any device-related safety events. Vesteck has developed a robust regulatory strategy targeting the U.S. market through a series of pre-submissions with FDA’s Division of Circulatory Support, Structural and Vascular Devices, receiving invaluable feedback. Our goal in this Direct to Phase II SBIR project is to complete activities required to clinically validate the safety and effectiveness of the Suture-Tight Suture Delivery system to support a Class II 510(k) premarket notification for FDA clearance. The specific aims of this project are to: 1) Conduct pre-clinical verification and validation of device performance requirements to demonstrate that the device design and pre- market manufacturing processes meet design requirements based on the V&V test strategy and test protocols reviewed by FDA; 2) Demonstrate device-readiness for pre-market clinical validation by successfully obtaining FDA approval of an Investigational Device Exemption (IDE); 3) Clinically validate device safety and effectiveness; and 4) Develop processes to scale up device manufacturing and reduce product costs. Successful completion of this SBIR Phase II project will be an important milestone indicating readiness for a marketing submission to the FDA. The activities of this SBIR project are most critical to not only achieving market clearance of a device that is safe, effective, and marketable, but also toward providing users and patients with a solution to the problem of long-term EVAR durability.