As if it’s bad enough going to the emergency room with chest pain, the additional trauma of being hooked up to all the monitoring machines can be unforgettable. And for the patient who needs long-term or at-home monitoring, the discomfort is multiplied.

Now, a start-up company is making it possible for patients to “wear” the monitoring equipment and still have freedom of movement without placing the electrode directly on the skin.

Textronics (Washington, Delaware) has received FDA clearance to market its textile-based ECG electrode for use in general electrocardiograph monitoring and recording procedures. The company calls its textile a “heart-sensing fabric,” saying that it offers an alternative to adhesive electrodes and metal wristbands commonly used with most ECG instruments on the market.

“It’s basically a highly conductive textile patch that’s picking up the electrical activity of the heart,” Stacey Burr, CEO of Textronics, told Medical Device Daily.

Textronics was created as a spin-off of an existing product effort. Burr was running the lycra business for DuPont (Wilmington, Deleware), which later sold the business to Koch Industries.

Burr decided to venture out on her own and focused on a specific piece of technology – a type of sports bra which held the small electrodes in place. With formation of Textronics, the company has created a non-invasive, flexible textile electrode technology, called the neumetrix heart monitoring system, for more comfortable monitoring of heart/respiration rates.

The Textronics technology enables the knitting of conductive sensing fibers directly into stretchy fabrics to create textile/electrode garments, straps and wristbands that can monitor physiological conditions comfortably as well as accurately.

Machine washable and reusable, these fabrics can be used for a wide range of ECG monitoring and recording applications, including cardiac event recorders, stress testing, Holter monitoring, trans-telephonic pacemaker monitors, and respiration sensing devices.

“The electrodes offer the same flexible textile electrode technology that we are using in the neumetrix heart monitoring apparel line,” Burr told MDD. “Basically these products have the same efficacy, and we’re using them in a consumer non-diagnostic sense for heart monitoring for sports and fitness applications.

“We really wanted to seek FDA approval to demonstrate the quality of the data that these textile electrodes can provide and to pave the way for us to work with partners in the medical device or telemedicine space, and give them confidence that the technology is here and ready to be integrated into their systems and applications as well.”

Burr said that the idea to make the ECG monitoring system came from contacts with people in the medical device space.

“From that experience,” she said, “in order for these electrodes to be adopted in their systems or devices which do require FDA approval, we [knew we] would need to give them some validation that these textile electrodes would be comparable to a sticky electrode. We felt comfortable that we could get that FDA status.”

She added: “We have already reached into fitness and sports markets, where heart rate monitoring is widely used to enhance performance and to ensure safety. We can now bring our ECG electrode technology to the healthcare market, where advances in technology are enabling people to monitor their biofeedback from the comfort of their own homes.”

Burr said that the ideal candidates for the electrodes are patients “who have applications where they might need to have electrodes in contact with the body for long periods of time. They are going to prefer some kind of wearable or ‘garment-based’ form factor as opposed to sticky electrodes — something that might be more comfortable for someone who is in a long-term or extended-wear situation.

“It’s not our view that somebody goes into the ER for a crisis situation that they will go for a shirt-based electric system — that wouldn’t make much sense. But for people in a long-term monitoring or rehab situation, this might be a more comfortable way to interface with the monitoring system.”

“We can now bring our ECG electrode technology to the healthcare market, where advances in technology are enabling people to monitor their biofeedback from the comfort of their own homes.”

Textronics sells sensor components and markets its own line of clothes for personal monitoring under the brand name NuMetrex.