Omeq Medical, a portfolio company of Israel-based Trendlines Group, has received the US Food and Drug Administration (FDA) approval for its EpiFinder smart device.

EpiFinder is a sensor-based, battery-operated single-use epidural placement device, intended for safe and accurate delivery of epidural injections.

It helps physicians in accurately positioning an epidural needle while performing the standard Loss of Resistance (LOR) technique.

EpiFinder is a simple, easy-to-use device that fits between a standard needle and syringe, requires no capital equipment, and is compatible with standard epidural syringes.

Also, the device can be easily integrated with the standard LOR technique and monitors tissue resistance at the needle tip to accurately detect needle penetration into the epidural space.

It protects the patient from complications arising from misplacement, said the medical device company.

Omeq Medical chairman Carl Rickenbaugh said: “With the FDA’s US marketing clearance achieved, we are excited to accelerate our discussions with the anesthesia community to bring this exciting development to market for the benefit of US patients.

“Our current discussions include major US anesthesia product distributors, strategic partners, and investors. We encourage interested parties to contact us directly.”

Omeq medical director and senior anesthesiologist at Johns Hopkins Hospital, David Gichtin said: “The EpiFinder smart device offers to improve the performance of epidural technique for potentially better outcomes, with the intent to make epidural procedures safer and easier for doctors and patients.”

Historically, epidurals have been performed using the LOR technique, which depends upon the clinician’s experience, dexterity, and tactile feedback to identify a narrow 4-5mm space.

The procedure initially fails in up to 30% of cases, and the needle tip inadvertently tears the protective sac surrounding the spinal fluid in more than 5% of cases.

It leads to severe headache and possible neurological complications in patients.

Omeq said that its EpiFinder provides physicians with an additional signal to identify the epidural space and is the first real improvement of this technique.

The company has conducted a first-in-human clinical study, which confirmed the safety and effectiveness of EpiFinder, for accurately placing an epidural needle.

Omeq Medical CEO Lior Margalit said: “We are grateful to the anesthesia community that has supported our development. 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 indicative 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 is accurate with the EpiFinder.”