US-based Milestone Scientific’s (MLSS) subsidiary Milestone Medical has secured CE Mark to market and sell its epidural injection system the CompuFlo Epidural Computer Controlled Anesthesia System (CompuFlo Epidural Model 6000) in Europe.
The system is intended for verification of needle tip placement in the lumbar epidural space in patients aged 18 years and older.
It will also be used for the delivery of medication and other fluids in a controlled manner in the lumbar epidural space as part of an in-patient or out-patient procedure established by their health care provider.
Milestone Scientific chief executive officer Leonard Osser said: "CE approval is an important achievement and further validation of our technology as our subsidiary moves towards commercial sale of the epidural injection system.
"Our subsidiary’s next steps involve securing strategic partners to distribute its products in Europe, as it has already done in the US. Injection technology has not changed meaningfully since the advent of the hypodermic syringe over 150 years ago.
"Millions of patients that require epidural drug delivery and millions of women who give birth each year choose not to have an epidural due primarily to safety concerns about the high risks associated with this injection.
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"Epidurals represent a multi-billion dollar global market and we believe our technology can transform these injections from an art to a science."
The injection technology is based on a patented dynamic pressure sensing system (DPS), which is used to measure the density of body tissue and thus help a clinician know the location of a hypodermic needle during an injection.
The system uses computer controlled technology to offer real-time feedback to the medical practitioner and identify with precision when a needle has reached the location where a drug should be administered to a patient.