The National Heart, Lung and Blood Institute (NHLBI) of the U.S. National Institutes of Health (NIH) has awarded VESTECK Inc. a Direct to Phase II SBIR Grant to support the pre-market development and clinical validation of the Suture-Tight™ Endovascular Suturing device (Award Number R44HL178318). This grant, totaling $1.98M, is broken into 2 years with initial first year award of $1.36M.
The project supported by the awarded grant will be led by Principal Investigator Kent Stalker along with the veteran team at VESTECK, including its Board of Directors and Scientific Advisory board, with their combined decades of expertise in the development, manufacturing and commercialization of more than twenty cardiovascular medical devices. The Suture-Tight™ Endovascular Suturing System is a novel medical device for the treatment of Abdominal Aortic Aneurysms (AAA) that uses an endovascular technique to secure the top (proximal) neck of implanted endografts to the aorta, preventing endograft migration.
The SBIR funding will support obtaining FDA approval of an Investigational Device Exemption (IDE) to conduct a pre-market pivotal trial, as well as the start-up and conduct of the trial, to clinically validate the Suture-Tight™ for FDA 510(k) clearance.
Federal Award Project Title:
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
Link to Grant: https://reporter.nih.gov/search/E5D_isWrgkO9FEPohEP1Sg/project-details/11185822