South African MedTech firm SAT debuts CentreFlow catheter in U.S. human trials

USA—South African medical technology company Strait Access Technologies (SAT), backed by the Bidvest Group and the University of Cape Town, has reached a significant milestone in the United States with its innovative cardiovascular device.

For the first time, surgeons have used SAT’s CenterFlow balloon catheter on human patients, addressing a long-standing safety challenge in aortic artery repair.

Two internationally recognised leaders in aortic surgery, Dr Arminder Jassar at Massachusetts General Hospital in Boston and Dr Joseph Bavaria at Jefferson University Hospital in Philadelphia, successfully performed the procedures.

SAT founder and Chief Medical Officer Dr Peter Zilla, alongside co-developers Dr Roman Gottardi and Dr Martin Czerny, confirmed that the results validate the device’s clinical value.

According to Dr Zilla, CenterFlow has the potential to fundamentally change how surgeons treat aortic aneurysms—dangerous bulges or ruptures in the aorta, which is the body’s largest artery and the main vessel carrying oxygen-rich blood from the heart to the rest of the body.

How the device works

During conventional aortic repair, surgeons must temporarily block blood flow while inflating a balloon to position a sleeve-like repair device.

This creates an extremely high-risk window, leaving both patients and surgeons with only seconds to complete a critical step.

CenterFlow changes this dynamic through a hollow-balloon design that keeps blood flowing continuously during inflation.

Rather than racing against a ticking clock, surgeons can now work under more stable conditions, with the treatment window extending from seconds to minutes while maintaining the necessary stability and radial force required for effective repair.

The device is the result of nine years of development, and it recently received US FDA 510(k) regulatory clearance for commercial use — a rigorous approval process that confirms its safety and effectiveness for clinical application.

South Africa’s growing role in global MedTech

This achievement places South Africa firmly on the map as a contributor to global medical technology innovation.

Cardiovascular disease remains a significant health burden both locally and worldwide, and access to safer, more advanced devices directly translates to better patient outcomes.

It also reduces reliance on imported technologies, strengthening local capacity in a field where innovation can save lives.

SAT’s success demonstrates that world-class medical devices can be conceived, developed, and validated in South Africa—and that the country’s medtech sector is capable of making a meaningful difference in operating theaters worldwide.