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Published: 2012-09-12 01:19
Medfield's monitoring study approved by Medical Products Agency and Ethics Committee
Development of the stroke diagnostic tool Strokefinder is continuing. This is presently in the form of a Strokefinder (a hat-like device) which monitors TIA patients, and a study into this has now been approved. Clinical study MF 03 is planned to commence directly after the end of MF 02 in late September. In MF 03, the R10 system will be used with a hat-like device suitable for monitoring. The study will be focusing on monitoring TIA patients overnight and patients given clot-busting treatment during the daytime.
MF 03 is the first multi-centre study into Strokefinder, and Borås Hospital (SÄS) will be participating in this study together with Sahlgrenska University Hospital (SU). The study is expected to continue for six to ten months, depending on the patient inclusion rate. Around 200 patients in total are expected to participate. MF 03 has now been approved by both the Medical Products Agency and the Ethics Committee, with no remarks.

Medfield Diagnostics' first product, Strokefinder R10, has been undergoing clinical studies at the stroke unit at Sahlgrenska University Hospital for some time now, with promising results. The new monitoring form of Strokefinder has been developed primarily for the monitoring of TIA patients. There is a high risk of a TIA (Transient Ischaemic Attack) being followed by a stroke within the first few days following the attack. Medfields “stroke hat" means that patients can be monitored constantly overnight without having to trouble the sufferer.

"MF 03 is exciting in two different ways," says Patrik Dahlqvist, CEO of Medfield Diagnostics. "On the one hand, this is our first monitoring study involving a hat. This hat will be the method we use to hold the antennas in place in our future volume products. And on the other, this will be our first multi-centre study, and it will allow us access to a considerably greater number of patients than was previously the case."

Around 10 000 people in Sweden suffer from TIAs every year. 50 per cent of all secondary strokes take place within two days of the first symptoms of a TIA. Likewise, 10 per cent of patients then go on to suffer a full stroke within two days of a TIA. At present, patients with identified TIAs are admitted to the stroke unit as emergencies and undergo rapid examinations. Appropriate treatments are given after this, such as medicines to reduce blood pressure and thin the blood, and these treatments are then followed up by one to three days of monitoring at the stroke unit.

For full press release please visit www.medfielddiagnostics.comexternal link, opens in new window (in Swedish)

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Updated: 2012-10-04
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