Electrophysiology recording system
to better guide ablation therapy
Medical device company CathVision has signed a multi-million venture investment from Scandinavian-based investors VF Venture and Borean Innovation. The investment is directed at developing and market the company’s superior electrophysiology (EP) recording system for treating cardiac arrhythmia.
CathVision has developed a low-noise electrophysiology (EP) recording system, CathVision Cube, to help better guide ablation therapy through exceptional EP signal quality. The product comprises a proprietary low-noise console and computer software to stream, analyze and store EP signals.
CathVision Cube interfaces with all existing diagnostic catheters, mapping catheters and ablation catheters. The system is compatible with existing 3D mapping systems used simultaneously with CathVision Cube recording.
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.
Mads is biomedical engineer who founded CathVision ApS in 2010 after observing cardiac ablation procedures and trying to solve noise problems. Mads worked as a management consultant in The Boston Consulting Group before receiving institutional investor capital to grow CathVision from 2014.
Andy is an experienced leader and engineer who completed his undergraduate studies at Rensselaer and graduate work at MIT. His expertise is in product development and commercialization, and has experience in a broad range of medical device clinical areas including cardiology.
Sigge is a biomedical engineer with expertise in medical signal acquisition and processing. He has developed systems for analysis of ECG, EEG and EMG in the areas of seizure detection, epilepsy and sleep/wake before joining CathVision in 2014.
Christian is an electrical engineer and experienced CTO with broad experience in medtech companies; Everest Biomedical, Brainscope, Medotech and more. Christian has successfully led start-up companies through regulatory product approval, proof-of-business and exit processes.
Harold has a PhD in biomedical engineering from University of Toronto and a proven track record in the areas of strategic planning, business and new product development, and due diligence. He was a co-founder of Biomedical Instrumentation Inc., a world leader in cardiology systems used to diagnose electrical problems within the heart.
Lene has a PhD in medicinal biochemistry from University of Copenhagen. She is a fund manager at Borean Innovation where she oversees life science portfolio companies. Lene previously worked as vice president of business development at Visiopharm 2009-2012 and vice president of IPR and legal affairs at Action Pharma 2007-2009. Lene was a patent attorney at Plougmann & Vingtoft.
Tonni is a medical engineer with an E*MBA from SIMI. Tonni is Managing Director and Venture Partner at VF Venture. He serves within life science and medtech where he has 25+ years executive experience in global sales & marketing, including experience with cardiology from Guidant, St. Jude Medical, Sorin Group, and DanMed.
Independent Board Member
Magnus has a PhD in atrial fibrillation and clinical electrophysiology from University of Lund. Magnus led Biosense Webster’s succesful commercialization in Europe and Middle East (1997-2008), then joined Stereotaxis (2008-2011). Magnus is currently a venture partner at Peppermint Venture Partners, Berlin, and is an independent board member at CathVision.
A formal scientific advisory board of respected and innovative electrophysiologists is currently under formation.