A medical device that aims to make administration of epidurals more reliable and safer has been cleared by the FDA, giving its developer Omeq Medical its first approved product.
The EpiFinder is designed to help anesthetists accurately position an epidural needle using the 100-year-old loss of resistance (LOR) technique, which relies on them placing the needle by feel.
Using this approach, the anesthetist waits for a moment of pushback as the needle encounters the ligamentum flavum, the last barrier before it enters the epidural space.
They then attach a syringe filled with either air or saline and incrementally advance the tip of the needle, tapping the plunger to feel for resistance—picture pressing down on the plunger of a syringe when your finger is over the end.
RELATED: Samsung gets FDA clearance for irregular heart rhythm notifications
When the needle crosses the ligament and enters the epidural space, the resistance mostly disappears and the plunger depresses much more easily. At that point, a catheter used to deliver the anesthetic can be introduced in the same location, and the needle withdrawn.
Here’s the problem. In up to 30% of cases, the technique fails at the first attempt, and while that is usually corrected without ill effects to the patient multiple insertions hike the time and cost of the procedure.
Moreover, in up to 5% of procedures, the needle accidentally tears the protective membrane surrounding the spinal fluid—a complication known as a wet tap—which can lead to severe headaches and potentially neurological side effects. Those are estimated to cost the U.S. healthcare system $500 million a year, according to Omeq.
EpiFinder aims to improve on the success rate and reduce complications by taking the operator’s skill and experience level out of the equation. It is a battery-operated, disposable sensor that fits between a standard needle and syringe and automatically monitors tissue resistance at the needle tip to detect when it enters the epidural space.
In a clinical trial, clinicians said they were able to safely provide successful epidural block in all 31 patients using the device with accurate needle placement.
Now that FDA approval is in hand, Israel-based Omeq is talking to “major US anesthesia product distributors, strategic partners, and investors” to gauge how it can start commercial sales of the device, according to a press release.
“We now turn our focus to bring EpiFinder to US patients receiving epidural injections,” said Omeq Medical CEO Lior Mangalit. “EpiFinder offers the potential to become the new standard of care while performing LOR.”
The potential market for the device is certainly very large if it does start being used routinely by health systems. Omeq estimates that there are 40 million epidural injections given annually, representing a billion-dollar category that is growing at around 9% a year. Around 10 to 11 million of those epidurals are carried out in the U.S.
Researchers have looked at using imaging procedures like ultrasound and fluoroscopy to guide the insertion process, none of which have gathered much traction yet, while other medtech companies are also taking a device approach to improving LOR.
That includes Flat Medical with its EpiFaith syringe, which has been designed with a visual feature that helps the anesthetist see when the LOR point is reached. The Japanese company’s U.S. suppliers recently won a contract to supply the device for use by the U.S. military.
New Jersey-based Milestone Scientific meanwhile has an instrument-based solution called CompuFlow, which provides a digital reading of pressure four times per second as the epidural needle is inserted and according to the company can differentiate between “true and false” LOR.
CompuFlow was first approved by the FDA to guide epidural injections in 2017, but take-up and sales so far have been modest. The company said earlier this year that it is pursuing U.S. federal supply service approval, which could open up the market.
