According to a statement, HemoSep is set to change the healthcare sector after gaining the CE mark and receiving Canadian national approval, following successful clinical trials in the University of Kirikkale University Hospital in Ankara, Turkey.
The device is designed to recover blood spilled during open-heart and major trauma surgery and to concentrate the blood cells for transfusion back to the patient. This process, known as autotransfusion, reduces the volume of donor blood required and the problems associated with transfusion reaction.
Prof Terry Gourlay, who led the development of the technology at Strathclyde University’s Department of Biomedical Engineering, said: ‘This is a fantastic example of real collaboration between Strathclyde University and the medical-device industry to take this device from concept to clinical delivery.
‘The technology has distinct advantages over traditional techniques, which are not only costly but technically challenging and involve the use of a complex centrifuge and pumping apparatus by specialist technicians.
‘We expect further developments in the form of a derivative of this technology for use in children undergoing open-heart surgery where the challenges of blood conservation are even more critical.’
In the clinical trials, carried out in more than 100 open-heart surgery operations, the use of the HemoSep device is said to have significantly reduced the need for blood transfusions together with preservation of normal clotting mechanisms and a reduction in the inflammatory reaction often encountered after such surgical procedures.
The device consists of a blood bag, which employs a chemical sponge technology and a mechanical agitator to concentrate blood sucked from the surgical site or drained from the heart-lung machine after the surgery. The separated cells are then returned to the patient by intravenous transfusion.
Further clinical trials are planned, but the CE mark means that the device will now be sold to the healthcare sector. HemoSep has been licensed to Advancis Surgical, which will market and sell the device in all European territories, other regions that recognise the CE mark and Canada.
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