Cape Town Company Achieves First-in-Human Clinical Milestone in the USA with Innovative Medical Device

Strait Access Technologies (SAT), a medical technology company developing next-generation cardiovascular devices, today announced the successful first-in-human use of the CenterFlow® post-TEVAR stent-graft balloon moulding catheter, marking a significant milestone for the company. SAT shareholders include Bidvest, the University of Cape Town, founders and management.

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 centres. 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® was designed to address long-standing limitations of conventional balloon moulding catheters. Its unique architecture allows uninterrupted blood flow during inflation, enabling controlled, stable, and prolonged stent-graft moulding. 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 moulding 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 moulding. 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.