Handheld Devices Monitor Blood-Clotting Status of Patients

A range of handheld devices monitor the blood-clotting status of patients using anticoagulant treatments.

Coagmax and Coaglite are a point-of-care test and a home-use test respectively that clinicians and patients can use to establish the correct dosage of anticoagulation medication such as Warfarin and to monitor treatment. The devices incorporate a disposable Smartstrip that uses embedded sensors to measure the clotting speed of blood from a drop of the patient's blood taken by a finger prick, with the results displayed on a handheld reader.

The Smartstrip medical diagnostic strip is based on a microelectromechanical System (MEMS) with an on-board memory chip that was originally created as a movement system for nanobots. The coagulation status (clotting speed) of the patient is measured by tiny multilayered paddles on the surface of the strip and a memory chip ensures the device is calibrated to provide the highest levels of accuracy, while the MEMS technology means that high volumes of the device can be manufactured at low cost.

Microvisk Technologies (St. Asaph, United Kingdom) showcased the devices at the 2011 American Association of Clinical Chemists annual conference held at the Georgia World Congress Center in Atlanta (GA, USA) from July 24-28, 2011.

Both devices have a common design theme allowing instant recognition between the units and accessories. The devices are simple to use with a large display and buttons, shaped to give a comfortable fit to the hand– the home use device is sized to be discreet.

Multicenter European clinical trials of CoagMax and CoagLite are already under way in the United Kingdom and Germany. The devices will be introduced to the German market in November 2011 at Medica, a leading medical trade fair, which attracts over 137,000 visitors. Product launches in both countries are scheduled for early 2012.

Seven million people in the western world use Warfarin and the US Food and Drug Administration (FDA; Silver Spring, MD, USA) estimates that over one million new patients start taking the drug every year. Patients must have regular blood tests at their doctor’s surgery or hospital clinic to ensure they receive the correct dose. Warfarin is affected by food and exercise and if the dose is too low, there is a risk of blood clots forming which can result in a stroke or heart attack, while too high a dose can lead to a life threatening bleed.

John Curtis, CEO of Microvisk, said: “We are delighted at the overwhelming interest shown by United States distributors and potential partners in our CoagMax and CoagLite devices–it is extremely encouraging. We remain on track to commence US clinical trials this autumn and are gearing up for product launch there in summer 2012."

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