Portable Device Monitors Blood Clotting

A handheld medical device will allow patients and doctors to rapidly determine the international normalized ratio (INR) of blood clotting for the management of long-term oral anticoagulant treatment.

The SmartCheck is similar in size to a mobile telephone, and uses a single droplet of blood obtained by a simple finger prick. The blood droplet is placed onto a thromboplastin-treated strip, which is then inserted into the meter. In the meter, a microprocessor measures the biochemical reaction of the blood sample with thromboplastin, providing a digitally displayed reading generated within one minute.

The SmartCheck is a product of Stirling Medical Innovations (SMI; Stirling, Scotland, UK), and was developed under a research and development partnership with ITI Life Sciences (Dundee, Scotland, UK). Clinical trials of the system, involving more than 325 patients over a nine-month period, have been concluded successfully in Germany with the award of the European Community (CE) mark. Further clinical trials are ongoing to support an application to the U.S. Food & Drug Administration (FDA) for approval for point-of-care testing (POCT) use in the United States.

"Bringing SmartCheck successfully to the market is another major milestone in the provision of rapid diagnosis for near-patient or home-care treatment,” said Rob Hutchison, managing director of SMI. "This device has the potential to help millions of patients worldwide to monitor quickly and accurately their own condition in their everyday environment. Importantly, the empowerment of patients eases the pressure on healthcare professionals, freeing up their valuable time to treat others.”

The most common anti-coagulation drug treatment is warfarin, given to patients with a history of atrial fibrillation (AF), recurrent strokes, deep vein thrombosis (DVT), pulmonary embolism, or who have undergone heart valve replacement surgery. However, the optimal dose varies greatly from person to person; too small a dose increases the risk of clotting and too high a dose increases the risk of severe bleeding.


Related Links:
Stirling Medical Innovations
ITI Life Sciences