Omeq Medical, part of The Trendlines Group, has obtained regulatory approval from the US Food and Drug Administration (FDA) for its EpiFinder device that helps physicians precisely place an epidural needle while conducting the standard Loss of Resistance (LOR) technique.

EpiFinder is capable of providing physicians with an added signal recognising the epidural space.

It is a sensor-driven, battery-operated single-use epidural placement device that can be used for safe, accurate epidural injections.

Users can place the device between a standard needle and a syringe. It eliminates the need for capital equipment and is compatible with the existing epidural syringes.

EpiFinder also has the capability to monitor tissue resistance at the needle tip to accurately identify penetration of the needle into the epidural space, thereby safeguarding the patient from complications arising out of misplacement.

In a first-in-human clinical trial conducted by Omeq to show the safety and effectiveness of EpiFinder, it was found that the device can be safely used to accurately position an epidural needle.

Using EpiFinder, physicians of the trial were able to securely provide successful epidural blocks in all 31 patients.

Omeq Medical CEO Lior Margalit said: “We now turn our focus to bring EpiFinder to US patients receiving epidural injections.

“EpiFinder offers the potential to become the new standard of care while performing LOR. The procedure today is performed by advancing the epidural needle forward until the clinician senses a loss of resistance indicating that the epidural space in the spine has been reached.

“Using the same procedure, EpiFinder adds a second independent objective signal that the epidural space has been reached. Our initial clinical experience indicates that clinicians’ targeting and placement are accurate with the EpiFinder.”