CathVision is developing non-invasive technology to guide therapy for arrhythmia. The company’s product visualizes the smallest heart signals. High quality electrophysiology signals are a key component of delivering accurate therapy to complex arrhythmia.
Approximately 2% of the Western population suffers from cardiac arrhythmia, and hospital-based catheter ablation procedures are directed at terminating arrhythmia. Still, a number of challenging arrhythmia suffers from unsatisfactory low efficacy of 50%.
CathVision works to address the unmet need of successfully ablating challenging arrhythmia, such as atrial fibrillation and ventricular tachycardia.
New low-noise technology
CathVision’s product is a proprietary low-noise EP system that helps guide the medical professionals to the right spot for cardiac ablation. Contrary to competitors, CathVision has IP protected low-noise technology to provide the medical staff electrogram-driven clinical decision support.
CathVision is working with international leading physicians and electrophysiologists to test and market its proprietary low-noise EP recording system. The new investment allows the company to conduct clinical tests and market the product.
The EP/ablation market is a $3Bn market, comprising disposable catheters, 3D mapping systems and EP recording systems. CathVision is pursuing a market leader position in the EP recording system segment, while most competition is addressing 3D mapping and ablation catheter technology. CathVision expects market entry in 2018.
The proprietary hardware technology rejects noise, prevents signal artifacts and improves signal quality by a patented hardware design and patented amplification methodology. The high quality EP recordings are obtained without the use of digital noise filters, such as 50/60Hz notch filters, that are known to distort EP signals.
There are two possible set-ups dependent on the type of external 3D mapping system used:
a) The CathVision Cube is directly connected to catheters using catheter cables. The CathVision Cube shares the signals with the 3D mapping system to allow simultaneous signal acquisition. The CathVision Cube also connects directly to the external RF generator and the stimulator.
b) The external 3D mapping systems and/or recording systems are directly connected to catheters and the CathVision Cube is connected through a pin box.
The CathVision Cube software allows for real-time streaming and for multiple review windows for analyses, at a remote work station and on monitors in front of the physician.
The CathVision Cube is expected to have CE mark and FDA approval in 2018. The product has been validated in pigs in multiple EP labs with respected physicians over the past two years. Clinical studies are currently being scheduled.
In catheter-based ablation therapy, physicians are faced with many new advanced mapping systems and ablation technologies in order to guide and deliver successful ablation. New electrical equipment can often interfere with the signal quality of electrograms, leading to a risk of misinterpreting the cardiac electrophysiology. CathVision is developing a plug-and-play EP recording system that connects to existing EP lab equipment and to existing catheters.
Atrial fibrillation: Approximately 6 million people suffer from atrial fibrillation in Europe and the US. Persistent atrial fibrillation remains a challenging arrhythmia to cure. New mapping technologies aim to better measure and display cardiac electrophysiology. Multielectrode catheters now in use have smaller electrodes and higher density than prior generation catheters. These new catheters have better spatial resolution and can help identify gaps in the electrical isolation. For multielectrode catheter mapping of atrial fibrillation patients, unipolar electrograms are typically used rather than bipolar electrograms. Since unipolar electrograms are more prone to noise than bipolar electrograms, physicians often cannot see subtle signal morphologies, or are forced to use signal filters that add distortion.
Atrial tachycardia and ventricular tachycardia: These arrhythmias are characterized by macroreentrant loops within the myocardium. These are typically sustained by channels of slow conduction interspersed in scar tissue that are measured as small, low voltage late potentials. Identifying low-voltage late potentials is central to guiding and validating successful ablation. Clean, low-noise electrograms are therefore vital for these types of arrhythmia.
Use of unipolar vs. bipolar electrograms: Bipolar electrograms are currently the standard used during EP/ablation procedures. Bipolar electrograms represent local activity, as they are mathematical subtraction of two adjacent electrode signals. Bipolar electrograms theoretically represent the velocity of change (dv/dt) of voltage in this local area. This means an activation front is clearly depicted as a sharp deflection. However, information about propagation direction and propagation depth perpendicular to the electrodes is lost. Unipolar signals, on the other hand, are a local electrode signal subtracted from an electrode signal ’infinitely far away’. Unipolar signals are truer representations of heart activity seen from each electrode. Unipolar signals have been largely abandoned due to the higher noise displayed using traditional recording systems. Today, especially for ablation of atrial tachycardia and ventricular tachycardia, noise-free unipolar electrograms hold the key to interpreting the isthmus and exit block of reentrant loops.