Acutus Medical, a Biotectix licensee, received CE Mark approval for the AcQMap high resolution imaging and mapping system and AcQMap 3D imaging and mapping catheter to diagnose and treat complex cardiac arrhythmias.
With CE Mark, the AcQMap system and catheter have met the requirements of all relevant Medical Device Directives in the European Union, making it the first CE Mark approval of a medical device using Biotectix’s Amplicoat, 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, according to Biotectix.
The coating can be applied to a variety of materials, which can eliminate the need for precious metals, and provides a potentially option for numerous applications including cardiac electrophysiology mapping, pacing, neural recording, and neuromodulation.
The Acutus AcQMap detects and displays 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, Richmond, CA, develops electro-conductive coating technologies for medical devices and non-medical applications. Acutus Medical, Carlsbad, CA, is a global heart rhythm technology company focused on diagnosis and treatment of cardiac arrhythmias.
