This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 868213
Confidence in Every Procedure
With CardioVia, physicians perform procedures confidently, knowing they're equipped with state-of-the-art technology designed for precision and patient safety
Leading a New Frontier in Modern Cardiology
Providing Safe, Efficient Access to the Heart’s Outer Surface
At CardioVia, we are developing minimally invasive devices intended to provide reliable access to the pericardium—the protective double-layered sac surrounding the heart.
The epicardial surface — the outer layer of the heart — is increasingly recognized as a critical access point for treating some of the most prevalent cardiovascular conditions, including cardiac tamponade, arrhythmias, heart failure, and myocardial infarction. It also enables promising emerging therapies such as left atrial appendage closure, epicardial lead placement, targeted drug delivery, stem cell therapies, and gene-based treatments.
These devices and opportunities will unfold greatly once safely and reliably epicardial access will be achieved. It is estimated that, annually, 2.5M patients in the U.S. and the EU will benefit from epicardial access due to a variety of pathological conditions.
At CardioVia, we leverage advanced technology and intuitive design to support physicians in performing cardiac procedures with confidence and precision. Our mission is to provide clinicians with specialized tools for safe and effective access to one of the body’s most delicate and vital organs—the heart.
“The best way to predict your future is to create it.”
Abraham Lincoln
The Clinical Need
Minimally invasive, safe and efficient access to the the
heart surface while generating a secure workspace
The Pericardium
The pericardium is a thin, double-walled sac that surrounds and protects the heart, while allowing it to move smoothly within the chest cavity. It consists of two distinct layers, and between them lies a potential space known as the pericardial space. In recent years, this space has gained growing recognition as a valuable therapeutic site for a range of advanced cardiac treatments.
The
Problem
Accessing the pericardial space presents a significant procedural challenge, as current techniques rely on exposed sharp needles directed toward the beating heart. This approach requires extreme precision and control, given the constant motion of the heart, the complexity of surrounding anatomy, and the close proximity to critical structures such as coronary vessels and cardiac chambers.
The Consequences
Complications can reach up to 30% of cases and include heart perforation. Such risks increase patient morbidity and mortality, diminish quality of life (QoL), and lead to additional interventions and higher healthcare costs. As a result, physicians often approach this critical therapeutic area as a last resort, despite its significant potential for patient care.
Current Procedure
The pericardial tissue is very thin, ~2 mm thick
Current techniques lack sufficient monitoring and control
During the insertion, the heart is in constant motion
Requires agility, experience and great precision
Technology
Precision Access to the Heart
CardioVia has developed the ViaOne Epicardial Access System — a minimally invasive, patented, and clinically validated medical device, recognized with the FDA Breakthrough Device designation for its potential to safely enable heart surface-based therapies. The ViaOne system is now FDA-cleared for use in treating cardiac arrhythmias, marking its first approved indication within our evolving clinical pipeline.
ViaOne is designed to provide controlled access to the heart's outer surface while avoiding the risk of puncturing the heart muscle or surrounding structures — a significant limitation of current techniques. The system integrates a concealed, blunt-tip needle with a unique geometric structure that leverages the natural differences between pericardial tissue and heart muscle. Integrated sensors continuously monitor the device's position, supporting safe navigation and entry into the pericardial space.
Designed for Clinical Excellence
Intuitive, user-friendly design for streamlined operation
Safe measured progress
Clear visual indicators
Special sensors for real-time procedural guidance
Creates a stable and secure workspace for therapeutic access
Allows controlled retraction of fluids
“Optimism is the faith that leads to achievement. Nothing can be done without hope and confidence."
Helen Keller
Market Trends
There is growing consensus that cardiac treatments are increasingly shifting toward a minimally invasive epicardial approach, moving beyond traditional endocardial catheterization
Ventricular Tachycardia
Ventricular tachycardia (VT) is a fast heart rhythm disorder that arises from improper electrical activity in the ventricles of the heart. When this happens, the heart may not be able to pump enough blood to the body and lungs because the chambers are beating so fast that they don't have enough time to fill properly. VT is responsible for most of the sudden cardiac deaths in the United States, at an estimated rate of 300,000 deaths per year1,2.
The Spanish Society of Cardiology’s cardiac intervention registry contains the highest number of centers in registry study for heart surface-based treatments, with 100+ cardiology centers being analyzed annually for more than a decade. A clear trend is observed in the shift from endocardial procedures towards heart surface procedures, as the efficacy of these treatments has become more widely understood over time. In 2017, 10.1% of ablation procedures were performed on the heart surface, and this number increased to 13.7% in 2018 and 19.8% in 20193.
The image on the left illustrates how, in certain cases, the source of the arrhythmia (marked in red) is located on the heart’s outer surface. In such scenarios, accessing the pericardial space is crucial for enabling effective ablation therapy4.
1. Out-of-hospital cardiac arrest surveillance --- Cardiac Arrest Registry to Enhance Survival (CARES), United States, October 1, 2005-- December 31, 2010; MMWR Survival Summ. 2011 Jul 29. 60 (8):1-19. McNally B, et al.
2. Outcome of patients with in-hospital ventricular tachycardia and ventricular fibrillation arrest while using a wearable cardioverter defibrillator. Am J Cardiol. 2017
3. Quesada A, Cózar R, Anguera I; Spanish Catheter Ablation Registry collaborators. Spanish Catheter Ablation Registry. 19th Official Report of the Heart Rhythm Association of the Spanish Society of Cardiology (2019). Rev Esp Cardiol (Engl Ed). 2020 Dec;73(12):1049-1060. English, Spanish. doi: 10.1016/j.rec.2020.08.022. Epub 2020 Nov 3. PMID: 33153956
4. Epicardial Substrate and Outcome With Epicardial Ablation of Ventricular Tachycardia in Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia. Fermin C. Garcia, Victor Bazan, Erica S. Zado, Jian-Fang Ren, Francis E. Marchlinski
Atrial Fibrillation
Atrial fibrillation (A-Fib) is an irregular heart rhythm that increases the risk of stroke, heart failure, and other serious cardiac complications. During A-Fib, the heart’s two upper chambers beat out of sync with the two lower chambers, disrupting normal blood flow.
A-Fib is the most common serious abnormal heart arrhythmia. Billions of dollars are spent annually on its diagnosis and treatment (more than $6 Billion in the USA alone each year)1,2. With more than 750,000 hospitalizations that occur each year, A-Fib contributes to an estimated 130,000 deaths each year3,4.
The graph highlights findings from recent studies evaluating the effectiveness of the hybrid approach. This technique combines epicardial and endocardial strategies, showing superior outcomes — particularly in patients with persistent A-Fib, who represent around 25% of all A-Fib cases5. While current endocardial procedures have an average success rate of around 60%, the hybrid approach consistently demonstrates improved success rates across multiple studies.
1.AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. Journal of the American College of Cardiology. 2014.
2. Mozaffarian D, Benjamin EJ, et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015.
3. Agency for Healthcare Research and Quality. Weighted national estimates. HCUP National Inpatient Sample. 2012.
4. Centers for Disease Control and Prevention. About multiple cause of death 1999–2011. CDC WONDER Online Database. 2014.
5. Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S. Epidemiology of atrial fibrillation: European perspective. Clinical Epidemiology. 2014.
Drug Delivery
There are promising indications for both improving existing drug therapies and enabling new treatments through direct delivery to the heart surface. This unique and targeted approach provides effective cardio-active therapy while helping to minimize many of the side effects associated with conventional drug delivery methods.
This field aims to enhance the effectiveness of current treatments by broadening their therapeutic window and by enabling the use of novel agents that are otherwise difficult to administer systemically, such as gene therapies and stem cell therapies. Emerging applications include regenerative treatments as stem cell therapy for heart failure and post-myocardial infarction recovery.
CardioVia enables minimally invasive, safe, and efficient delivery of therapeutic agents directly to the epicardial space (the heart surface).
1. "Delivery of drugs, growth factors, genes and stem cells via intrapericardial, epicardial and intramyocardial routes for sustained local targeted therapy of myocardial disease Mikhail Maslov, Stephan Foianini & Mark Lovich"
Complications related to epicardial access can be further subdivided into those related to (1) RV puncture and (2) vascular injury. RV puncture can occur in up to 17% percent of cases in which percutaneous access is attempted.
Unusual Complications of Percutaneous Epicardial Access and Epicardial Mapping and Ablation of Cardiac Arrhythmias
The hybrid approach could hold significant promise for those patients with persistent or longstanding persistent, drug-resistant AF to offer improved results over minimal access surgical ablation or catheter ablation alone.
Trends in Catheter Ablation for Atrial Fibrillation in the United States 2017 Expert Consensus Statement
The epicardial ablation is an essential approach that must be available in an EP laboratory but the complexity of all the problems connected limits it extensive use only in high volume Centers provided of
the necessary skillnes
and competences.
Epicardial Ablation For Ventricular Tachycardia
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