South African cardiovascular innovation reaches major milestone in United States

Novel dilatation balloon catheter gives surgeons more time and stability during life-saving aortic artery repair procedures

Overview

South African innovation goes global: Strait Access Technologies (SAT) achieves first human use of its CenterFlow® balloon dilatation catheter in the USA.

Breakthrough design: Unique hollow balloon design allows uninterrupted blood flow, giving surgeons more time and stability during life-saving aortic artery repair procedures.

Regulatory milestone: CenterFlow® recently received U.S. FDA 510(k) clearance for commercial use.

World-class validation: First procedures performed at internationally renowned, Massachusetts General Hospital and Jefferson University Hospital by leading cardiovascular surgeons.

Investor opportunity: SAT, whose shareholders include JSE-listed Bidvest Group and the University of Cape Town, is developing a new generation of aortic heart valves for a procedure known as Transcatheter Aortic Valve Replacement (TAVR). SAT’s heart valves are designed for extended durability, making TAVR possible in younger patients.

[Cape Town, South Africa, 24 March 2026]:

Strait Access Technologies (SAT), a pioneering medical technology company based at the University of Cape Town, has announced the successful first human use of its CenterFlow® balloon catheter in the United States, marking a significant step forward in addressing a critical safety challenge in aortic artery repair procedures.

This milestone not only marks a major advancement in patient outcomes globally but also highlights South Africa’s role as a leader in medical technology innovation.

Cardiovascular disease is a major health burden in South Africa and globally. Access to safer, more advanced devices means improved outcomes for patients and reduced reliance on imported technologies.

Breakthrough In Aortic Repair Procedures

During conventional aortic artery repair, blood flow is temporarily blocked while a balloon is inflated to mould a sleeve-like repair device, creating an extremely high-risk window for patients and surgeons alike.

The CenterFlow® catheter incorporated a hollow-balloon design that allows uninterrupted blood flow during inflation, enabling surgeons to operate under more stable conditions and with extended timeframes when repairing life-threatening weaknesses or ruptures in the aorta, known as aneurysms.

The aorta is the largest artery in the human body and the main vessel that carries oxygen-rich blood away from the heart to the rest of the body.

Regulatory And Clinical Milestones

Following nine years of development, the device recently received U.S. FDA 510(k) regulatory clearance for commercial use.

The first in-human procedures were successfully performed at Massachusetts General Hospital in Boston and Jefferson University Hospital in Philadelphia by internationally recognised leaders in aortic surgery, Dr. Arminder Jassar and Dr. Joseph Bavaria.

Dr. Peter Zilla, founder and Chief Medical Officer of SAT, together with co-developers Dr. Roman Gottardi and Dr. Martin Czerny, commented:

“This first use in patients confirms that CenterFlow® has real clinical value and the potential to change how aortic aneurysms are treated. By extending the treatment window from seconds to minutes while maintaining stability and radial force, it represents a meaningful advance in patient care”

Growth And Investment Potential

SAT’s shareholders include the Bidvest Group, the University of Cape Town, founders, and management.

This milestone strengthens the company’s trajectory toward broader clinical adoption and supports its strategy to build a differentiated portfolio of cardiovascular devices.

With a focus on improving patient outcomes while addressing high-value global markets, SAT is positioned as an attractive partner for investors seeking to back innovation with proven clinical impact.

For more information, please visit https://www.straitaccesstechnologies.com.

Issued by Aprio on behalf of Strait Access Technologies

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