SAT’s FDA-Cleared CenterFlow Post-TEVAR Moulding Catheter Used in FIH Procedures

July 29, 2026—Strait Access Technologies (SAT), which is based in Cape Town, South Africa, announced the first-in-human use of its CenterFlow post-thoracic endovascular aneurysm repair (TEVAR) stent graft balloon moulding catheter. The CenterFlow catheter recently received FDA 510(k) clearance, noted the company.

According to SAT, CenterFlow devices have been used in multiple TEVAR procedures performed by Arminder Jassar, MBBS, at Massachusetts General Hospital in Boston, Massachusetts, and Joseph Bavaria, MD, at Jefferson University Hospital in Philadelphia, Pennsylvania.

SAT stated that CenterFlow’s architecture is intended to allow uninterrupted blood flow during inflation, enabling controlled, stable, and prolonged stent graft moulding.

As summarized in the company’s press release, clinical use of CenterFlow demonstrated intraprocedural stability with no observable balloon or graft migration during inflation and preserved perfusion with no measurable pressure gradient across the treated aortic segment. The catheter’s performance was comparable to or exceeded that of traditional moulding balloons, while enabling a longer and more controlled treatment window.

The early clinical results validate CenterFlow’s value of combining flow permissiveness, robust radial force, and procedural stability in a single device, stated SAT.