Strait Access Technologies Achieves First-in-Human Milestone with CenterFlow® Following TEVAR
Cape Town, South Africa — Strait Access Technologies (www.straitaccesstechnologies.com, e-mail info@sat.za.com), a medical technology company developing next-generation cardiovascular devices, today announced the successful first-in-human use of its CenterFlow® post-TEVAR stent-graft balloon molding catheter, marking a significant clinical and commercial milestone for the company.
The CenterFlow® catheter, which recently received U.S. FDA 510(k) clearance, was used in multiple Thoracic Endovascular Aortic Repair (TEVAR) procedures at leading U.S. academic centers. Procedures were performed by Dr. Arminder Jassar at Massachusetts General Hospital in Boston and Dr. Joseph Bavaria at Jefferson University Hospital in Philadelphia—both internationally recognized leaders in aortic surgery.
CenterFlow® is designed to address long-standing limitations of conventional balloon molding catheters. Its flow-permissive architecture allows uninterrupted blood flow during balloon inflation, enabling controlled, stable, and prolonged stent-graft molding. This contrasts with traditional fully occlusive balloons, which can be highly sensitive to physiologic pulsatility, increasing the risk of endograft movement and branch vessel compromise.
In clinical use, CenterFlow® demonstrated:
Excellent intraprocedural stability, with no observable balloon or graft migration during inflation
No measurable pressure gradient across the treated aortic segment, confirming preserved perfusion
Performance comparable to or exceeding traditional molding balloons, while enabling a substantially longer and more controlled treatment window
These early clinical results validate CenterFlow®’s core value proposition: combining flow permissiveness, robust radial force, and procedural stability in a single device—an unmet need in post-TEVAR optimization.
Dr. Peter Zilla, Founder and Chief Medical Officer of SAT, together with co-developers Dr. Roman Gottardi and Dr. Martin Czerny, commented:
“This first-in-human experience confirms the clinical relevance of CenterFlow® and underscores its potential to redefine post-TEVAR stent-graft molding. By extending the effective treatment window from seconds to minutes while maintaining stability and radial force, we believe CenterFlow® represents a meaningful advance in aortic endovascular therapy.”
SAT believes this milestone positions CenterFlow® strongly for broader clinical adoption, supporting the company’s strategy to build a differentiated portfolio of cardiovascular devices that improve procedural safety and outcomes while addressing high-value, underserved segments of the endovascular market.