HIGH WYCOMBE, England, January 29, 2013 /PRNewswire/ --
European regulators have approved CE Mark extensions for the transformational geko device, designed to increase blood circulation for a range of circulatory disorders.
Bosses at Firstkind Medical, a wholly owned subsidiary of Sky Medical Technology, say the decision will allow the geko™ device to move beyond its initial use for the prevention of deep vein thrombosis (DVT) and reduce global healthcare costs in the process.
Clinicians currently use the device as an alternative to compression stockings, IPC devices or anticoagulants for DVT prophylaxis. The expanded approvals will allow clinicians to use the geko to promote wound healing, prevention and treat oedema, venous insufficiency and ischemia, where the veins struggle to send blood back from the legs to the heart.
"This new approval will allow us to extend the proven circulation benefits of geko device to a number of key clinical indications. It's a clever device, simple to use and well tolerated by patients, so we're pleased that we'll be able to help them in other ways," said Ross.
The wristwatch-size device fits to the back of the knee and delivers painless electrical impulses, via the common peroneal nerve, to gently activate the muscle pumps in the lower leg. The mechanism of action returns blood to the heart at a rate shown to be up to 70% of walking, without the user having to move or exert energy.
"It's this simplicity and accelerated patient mobility that differentiates the geko device" says Ross. "Now we can expect better patient outcomes across a range of indications, reduced length of hospital stay and substantial cost savings for health services globally."
Issued on behalf of Firstkind Medical Ltd by Paver Smith.
Note to editors:
Firstkind Medical Ltd
Firstkind Medical Limited is a wholly owned subsidiary of Sky Medical Technology Limited ("Sky Medical"), a privately-held UK company based in High Wycombe, Buckinghamshire.
Sky Medical manufacture medical devices using OnPulseTM, Sky Medical's proprietary neuromuscular electro-stimulation technology, indicated for increased blood circulation, for the prevention of venous thrombosis, for the prevention and treatment of oedema, for promoting wound healing and for the treatment of venous insufficiency and ischemia. The clinically effective OnPulseTM technology is non-invasive and embedded within the small, portable, one-size-fits-all gekoTM device, that is easily attached to the back of the knee.
The gekoTM device, incorporating OnPulseTM technology, has received CE Marking and is approved in Europe, Australia and Canada for increasing blood circulation, for the prevention of venous thrombosis, for the prevention and treatment of oedema, for promoting wound healing and for the treatment of venous insufficiency and ischemia. The gekoTM device and other embodiments of the OnPulseTM technology have not been cleared by the US FDA and are not available for sale in the USA.
SOURCE Firstkind Medical Ltd