What is Electrophysiology?
Electrophysiology involves the measurement and analysis of electrical signals in living organisms, particularly in cells and tissues of the body. This can include:
- Cardiac Electrophysiology: Studying the electrical activity of the heart to diagnose and treat conditions like arrhythmias (abnormal heart rhythms).
- Neurophysiology: Investigating the electrical activity in the nervous system, including the brain and nerves, to understand how they function and to diagnose conditions like epilepsy or nerve disorders.
- Muscle Electrophysiology: Evaluating the electrical activity in muscles to diagnose and monitor conditions such as myopathies or neuromuscular disorders.
- Cellular Electrophysiology: Examining the electrical properties of individual cells, such as neurons, to better understand their role in various physiological processes.
Radiofrequency energy catheters used in cardiac electrophysiology.
Electrophysiology Medical Devices
Electrophysiology (EP) devices are specialized instruments and equipment used by healthcare professionals, particularly cardiologists and electrophysiologists, to diagnose and treat various cardiac arrhythmias and related conditions
These devices are crucial for studying the electrical activity of the heart and for performing procedures such as ablation to correct abnormal heart rhythm.
Key devices include:
- Electrocardiography (ECG) machines for heart electrical activity,
- Holter monitors for continuous rhythm recording, and
- Event monitors for intermittent arrhythmias.
- Electrophysiology Study (EPS) equipment, like specialized catheters and recording systems, diagnose and map arrhythmias.
- Ablation catheters treat arrhythmias via energy delivery.
- Implantable cardiac devices such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices regulate heart function.
- Loop recorders monitor rhythms long-term.
- Imaging systems like Intracardiac Echocardiography (ICE) assist in procedures.
Electrophysiology recording software and remote monitoring systems enhance diagnostics and patient care, contributing to ongoing advancements in electrophysiology.
Electrophysiology catheter electrode basket.
Insights into the Electrophysiology Medical Device Market
The electrophysiology medical device market is a fast-growing segment of the overall cardiovascular device market. As per the Verified Market Research estimates, the global electrophysiology device market was valued at $5 billion in 2022 and is expected to reach $13.2 billion by 2030, at a CAGR of 11.47%.
The key reasons contributing to the growth in this segment are:
- the aging population,
- increasing incidence of heart rhythm disorders,
- and advancements in technology.
Most importantly,
- the increasing adoption of minimally invasive procedures and
- the use of remote monitoring instruments
contribute to this segment's growth.
Precision laser ablation and laser welding of electrophysiology catheter components.
Solutions for Electrophysiology Medical Devices by AMETEK EMC
AMETEK Engineered Medical Components (EMC) specializes in manufacturing Electrophysiology (EP) Medical Devices as one of many key medical device segments. Design and manufacturing solutions include
- mapping and sensing electrodes,
- mapping and sensing spline assemblies,
- imaging wire harnesses,
- pull wire assemblies,
- magnetic positioning cables, and
- custom interconnects.
AMETEK EMC will also design and assemble the entire
- high-density mapping catheters,
- steerable & non-steerable catheter shafts,
- catheter input modules, and
- generator modules.
Example of use-case of AMETEK EMC’s Solutions
One of the crucial steps in the diagnosis of distorted heart rhythm disorders such as atrial fibrillation and ventricular tachycardia are mapping the electrical signals. Specialized catheters are used in this process. These catheters are inserted into the patient's heart through the vascular system to investigate its electrical activity and identify the tissues that are giving the abnormal electric signals.
And after diagnosing the abnormal electrical signals, the tissue of the heart can be treated using the minimally invasive surgical technique of ablation. During the ablation catheter treatment, a higher current is provided through the catheter into the heart tissue through electrodes.
AMETEK EMC, with is expert brands Avicenna, TSE and Laserage, manufactures catheters for cardiac mapping catheters as well as ablation. Both brands are heavily involved in the electrophysiology space:
- Avicenna creates custom wire sets for the electrodes and also ablates the insulation from the contact wires. Avicenna also laser-welds the contact wires to the electrodes, feeds the wire inside the catheter, and clamps the electrode on the insulating sleeve of the spline.
- TSE manufactures unique cable assemblies and interconnectors for the catheters that meet customer-specific requirements. A collaborative design process is used to understand the customer’s total requirements. Once complete, custom cables are manufactured in the United States where also numerous electrical contacts are attached to the connecting assembly.
- LASERAGE offers precision laser cutting, laser welding, shape-setting, and finishing of the nickel-titanium frames of catheters. Laserage will also laser cut and weld the steering mechanisms for the steerable catheter assemblies.
Read the case study AMETEK EMC manufactures OEM’s next generation diagnostic electrophysiology catheter.
AMETEK EMC is a leading provider of advanced technology products and systems for the medical device industry, with a strong focus on precision engineering. More than half of major OEMs in the electrophysiology field utilize AMETEK EMC’s collaborative design and manufacturing capabilities.
High Quality Biomaterials
All electrophysiology components are manufactured using industry-approved and standardized biomaterials, for example metals such as titanium, platinum-iridium, Nitinol, and stainless steel or polymers like silicone and PTFE.
Materials are carefully selected according to industry standards depending on their biocompatibility, strength, and durability to ensure accurate electrical signals, precision, and optimal treatment for patients. All manufacturing processes are compliant with quality management systems such as ISO 13485. All facilities are ISO 13485 registered.
The electrophysiology device component market is a critical market with a high focus on precision, reliability, and innovation. With over 25+ years of experience in this market, AMETEK Engineered Medical Components has stood the test of time to continuously offer advanced, creative, and efficient solutions to medical device clients.