South African medical technology innovation sees successful maiden use in the US
University of Cape Town- (UCT-) based South African medical technology company Strait Access Technologies (SAT) reported on Monday that its CenterFlow balloon dilation catheter had been used in humans for the first time. The first two surgeries using the device had both been conducted in the US, at Massachusetts General Hospital in Boston and Jefferson University Hospital in Philadelphia, Pennsylvania.
“This first use in patients confirms that CentreFlow has real clinical value and the potential to change how aortic aneurysms are treated,” affirmed SAT founder and chief medical officer Dr Peter Zilla. “By extending the treatment window from seconds to minutes while maintaining stability and radial force, it represents a meaningful advance in patient care.”
Hitherto, during repairs to the aortic artery, which is the largest artery in the human body, a little balloon was inflated to mould a repair device (which looked like a sleeve). Unfortunately, inflating this balloon temporarily blocked the blood flow, which created a period of high risk for both the patient and the surgeons, giving very little time for the work to be done.
CenterFlow uses a hollow balloon which allows the blood to flow while it is inflates and moulds the repair device. This creates more stable conditions for the surgeons and gives them more time to repair the aneurysm (which is a weakness or rupture in the aorta, and is life-threatening).
The development of the CenterFlow took nine years, with Dr Roman Gottardi and Dr Martin Czerny as the co-developers. It recently received US Food and Drug Administration 510(k) regulatory clearance, permitting its commercial use. The development of the device highlights that South Africa is a leader in technological innovation in medicine.
“This milestone strengthens the company’s trajectory toward broader clinical adoption and supports its strategy to build a differentiated portfolio of cardiovascular devices,” stated SAT. “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.”
In addition to its founders and management, the company’s shareholders include UCT and the Bidvest Group.
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