With CE Mark, the AcQMap system and catheter have met the requirements of all relevant Medical Device Directives in the European Union (EU), making this the first CE Mark approval of a medical device using Biotectix’ Amplicoat™.
Amplicoat is a highly durable, biocompatible coating that enhances communication at the interface of human tissue and medical device electrodes. The material enables higher signal fidelity, reduced power requirements, device miniaturization, and increased safe stimulation capabilities.
Amplicoat overcomes many of the limitations of other conductive coatings, including poor durability, difficult processing requirements, and limited performance. The coating can be easily applied to a variety of materials, which can eliminate the need for precious metals.
This provides a potentially optimal solution for numerous applications including cardiac electrophysiology mapping, pacing, neural recording, and neuromodulation.
"This is a major milestone for our company and for the treatment of complex cardiac arrhythmias such as atrial fibrillation," said Jeff Hendricks, PhD, Director of Engineering and Co-Founder of Biotectix.
"The speed, signal quality, and resolution of Acutus’ AcQMap system are impressive. We are very pleased to work with Acutus Medical on their innovative system and are delighted with the regulatory approval. This will help lay the groundwork for approval of many more medical devices that benefit from our Amplicoat electrode coating."
Omar Amirana, MD, Acting CEO and board member of Biotectix, added, "We are extremely proud to partner with Acutus Medical. This marks a pivotal moment for Biotectix as we enter the commercialization stage and begin to execute on the Biotectix revenue model."
Acutus’ AcQMap is the first and only system to detect and display both standard voltage-based and higher resolution charge-source (dipole density) maps.
The system is also able to generate real-time, 3-D images of the heart chamber using ultrasound with quality comparable to a CT or MRI in a matter of minutes.
Dipole, non-contact mapping creates a highly accurate, instantaneous global view that captures the activation pattern of every heartbeat, making it uniquely capable of mapping and displaying both stable and unstable cardiac arrhythmias.
Biotectix develops electro-conductive coating technologies for medical devices and non-medical applications.
