Medfields monitoring study approved by the Swedish FDA and Ethics Board
The development of Strokefinder continues. Now as a supervisory Strokefinder (“stroke hat”) for TIA patients, whose study now is approved. The clinical study MF 03 is scheduled to start immediately after MF 02 ends at the end of september. In MF 03 the R10 system will be used with a hat adapted for monitoring. The study focuses on the monitoring of TIA patients at night and patients receiving anticoagulant treatment during the day.
MF 03 is the first mulity-center study for Strokefinder, where Borås Hospital (SÄS) is included in the study together with Sahlgrenska University Hospital (SU). The study is expected to last 6-10 months depending on patient inclusion rate. In total, approximately 200 patients participate. MF 03 is now approved by both the Swedish FDA and the Ethics Board without comment.
Medfield Diagnostics first product Strokefinder R10 has been included in clinical trials for a long time at the Stroke Unit at Sahlgrenska University Hospital with promising results. The new supervisory Strokefinder is primarily developed for the monitoring of TIA patients. TIA (Trans Ischemic Attack) represent a high risk of stroke within the first days. Medfields “stroke hat” means that the patient can be monitored continuously at night without having to disturb the patient.
– MF 03 is interesting in two ways, says Patrik Dahlqvist, CEO of Medfield Diagnostics. First, it’s our first monitoring study of the hat, which will be the method of keeping the antennas in place in the future of our volume products. Not only is it our first multi-center study, which means we will have access to a much larger numbers of patient than before.
In Sweden 10 000 people are affected by TIA each year. 50 percent of all secondary stroke appears within two days after the first TIA symptoms. 10 percent of the victims suffer a full stroke within two days after a TIA. Today, patients with acute TIA identified is transported to the stroke unit for a rapid investigation with appropriate treatment as antihypertensive and anticoagulant medication is inserted followed by the monitoring of a stroke unit in 1-3 days.