Gelweave™ Vascular Prostheses

Gelweave™ Vascular Prostheses are gelatin-sealed woven polyester grafts designed to repair or replace damaged and diseased vessels of the thoracic and abdominal aorta in cases of aneurysm, dissection, or occlusive disease. Branched configurations support debranching procedures and hybrid approaches combining open surgical debranching with endovascular repair. The Valsalva variant is specifically indicated for aortic root replacement.

Both subject and predicate devices use identical woven polyester textile technology with PET yarn and bovine gelatin sealing. Technological differences include a change in gelatin supplier, change in yarn supplier, implementation of a new sterilization suite, and addition of new device configurations. The core materials, design principles, and operational mechanisms remain the same.

Not stated in this summary.

The device achieves substantial equivalence through identical intended use and shared foundational technology (woven polyester with bovine gelatin). Although supplier and sterilization changes occurred, nonclinical testing—including bench testing, sterilization validation, packaging, shelf-life, biocompatibility, chemical characterization, and an animal performance study—demonstrated that these modifications do not affect safety or effectiveness. No clinical testing was needed because the material composition, design, and principles of operation remain unchanged from the predicate device.