Milestone Scientific's new FDA-cleared epidural instrument senses pressure

By Jeff Lagasse
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Note: This article has been updated to clarify the claims being made by Milestone Scientific about its new technology.

If Milestone Scientific has its way, epidural procedures will no longer be done blindly by feel.
 
The company has developed a technology that will be used for epidural procedures, and allows anesthesiologists and other clinicians the ability to determine the pressure at the tip of a needle in real-time. If widely adopted, the technology has the potential to reduce procedural risks to patients, and perhaps even reduce the malpractice risks to medical professionals administering epidurals.
 
The newly cleared epidural instrument uses a new innovation to drug delivery called Dynamic Pressure Sensing, the same technology used by Milestone Scientific’s dental instrument, the Wand STA. In the dental application, Dr. Mark Hochman, Director of Clinical Affairs at Milestone Scientific, said it’s the pressure, and not the needle itself, that often causes a patient to experience pain.
 
“For the first time you precisely can control the rate of administration of a drug, but more importantly you can precisely monitor and control fluid pressure …,” Dr. Hochman went on to say. “We embarked upon a research project to determine what benefits could be realized from controlling and monitoring both flow-rate and fluid pressure as any drug leaves the needle into a tissue space.  That led to the development of a technology that has numerous applications for an unlimited number of different injections.”
 
Hochman and his team developed an algorithm that allows one to change the disposable components as well as the drug and it still ensures the operators ability to precisely control and monitor rate and pressure, in real time and on a continuous basis. They then took things one step further:  Since they were able to identify what the pressure was at the tip of a needle, the team used that as a feedback loop to control the instrument. 
 
The first in a series of studies on the technology’s efficacy indicated that it did, indeed, reduce patients’ pain perceptions. But the applications were found to go beyond that.
 
“Remarkably, when we started to use the technology, we noticed we were able to identify tissue type based on a pressure signature,” said Hochman. “If you think about it, radiology functions on that basis. You have different tissues of different densities. That’s what allows us to look at a radiograph. … We can identify a target in the body.” For epidural procedures, that target is the epidural space. Conventional practice relies on a subjective feel with a ‘loss of resistance’ syringe to locate the epidural space.

Milestone Scientific received CE Mark approval to market and sell the CompuFlo Epidural Instrument in Europe and other international markets, where commercial efforts have been going on for a little over a year. In June, the FDA gave Milestone Scientific the green light for use in the United States.
 
As for the avoidance of potential malpractice incidents, no specific data exists at the moment -- although Hochman said this side benefit makes sense from a logical standpoint.
 
“If the practitioner is able to identify the correct location with a higher degree of effectiveness and safety, it stands to reason we’re going to mitigate those risks; in putting the needle in the wrong location, that oftentimes leads to litigation,” he said. “We certainly believe there should be that reduction.”
 
The next step for the company will be to identify key opinion leaders in the U.S. and abroad and get the technology into their hands, working with key distributors for certain geographic areas.
 
“There’s no reason why the concept of subcutaneous drug delivery shouldn’t be brought into the 21st century,” said Hochman.