This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 868213
PROVIDES CONFIDENCE TO THE PHYSICIANS
By using CardioVia, physicians are able to work with great assurance knowing they have the ultimate device in their hands
Leading a new frontier in modern cardiology
Providing safe and efficient access to the pericardial space
We at CardioVia are developing minimal invasive access to the outer surface of the heart via the pericardium which is a double-walled sac that surrounds the heart.
The outer surface of the heart has been recognized as a promising entry route for the treatment of the most prevalent cardiovascular diseases such as cardiac tamponade, mapping & ablation for various arrhythmias such as Atrial fibrillation and Ventricular tachycardia, left atrial appendage closure, epicardial lead placement and in the future, epicardial pacemaker implantation, drug, stem cells and gene therapy.
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 US and the EU will benefit from epicardial access due to a variety of pathological conditions.
By using cutting edge technologies with the simplest ideas, CardioVia will be able to provide physicians with the right access to perform advanced cardiac treatments on the outer surface of the heart like never seen before. By using CardioVia's device, physicians will be able to perform procedures on one of the most delicate and complicated instruments that the human body has.
“The best way to predict your future is to create it.”
NOT SAFE - NOT EFFICIENT - NOT EASY
The Clinical Need
Minimally invasive, safe and efficient access to the pericardial space while generating a secure workspace
The pericardium is a thin (only 2 mm) double-walled sac that surrounds the heart, protects and lubricates its motion. It is composed of two layers, and in between these layers, there is a potential space called the pericardial space.
Penetration to the pericardial space carries a significant risk of damaging the heart as current procedures use an exposed sharp needle that is directed towards the beating heart and fails to generate a secure work space.
NOT SAFE - NOT EFFICIENT - NOT EASY
Complications can reach up to 30% and include heart puncture, cardiac tamponade and pericardial bleeding, which can result in an increase in patients morbidity and mortality. Quality of life (QoL) will deteriorate and will result in additional treatments and healthcare costs.
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
CardioVia's device performs an accurate entrance between the layers of the pericardium thanks to cutting edge technologies while changing the way we think about the access. NO needle is exposed towards the heart.
The procedure is performed in a controlled and measured manner, while synchronizing with the heartbeats and the system allows penetration to the outer surface of the pericardial space without the risk of puncturing the heart muscle.
While using a unique geometric structure tip, CardioVia's system utilizes the physiological differences between the pericardial tissue and the heart muscle itself.
Once inserted, the device anchors to the pericardium and serves as a pathway that allows through it easy and secure continuous access.
Having An Edge
Intuitive and easy to use
Safe measured progress
Visual status indicators
Special sensors for real-time detection
Generate a secure workspace
Allows controlled retraction of fluids
“Optimism is the faith that leads to achievement. Nothing can be done without hope and confidence."
Leading Studies & Latest Research
There is a consensus that more and more cardiac treatments are moving towards a
minimal invasive epicardial approach instead of traditional endocardial catheterization
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 graph displays the increased rate of VT ablation procedures performed through the pericardium out of the total VT ablations that were performed in a multi-central study3.
The imaging on the left shows that in some cases the focus of the arrhythmia (marked in red) is presented on the surface of the heart (The right column). In this case, it is shown that there is a high relevance in accessing the pericardial space in order to perform ablation procedures for a more efficient treatment4.
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. 15th Official Report of the Spanish Society of Cardiology Working Group on Electrophysiology and Arrhythmias, 2015
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 (A-Fib) is an irregular heart rate disorder that increases the risk for stroke, heart failure and other heart-related complications. During atrial fibrillation, the heart's two upper chambers beat out of coordination with the two lower chambers of the heart.
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.
This graph shows the results of recent studies that examined the efficiency of the hybrid approach. The superiority of the hybrid approach is particularly high in patients with persistent A-Fib which accounts for approx. 25% of A-Fib patients5.
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.
There are promising indications for the improvement of existing drugs by direct delivery to the epicardial space. This unique and specific area provides effective cardio active drug therapy without many of the side effects of conventional drug delivery methods.
This field aims to enhance outcomes of existing therapies by broadening their therapeutic window and to utilize new agents that otherwise could not be implemented systemically, such as gene and stem cells therapy. CardioVia will allow minimally invasive, safe and efficient agent delivery to the epicardial space.
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.
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.
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
Unusual Complications of Percutaneous Epicardial Access and Epicardial Mapping and Ablation of Cardiac Arrhythmias
Trends in Catheter Ablation for Atrial Fibrillation in the United States 2017 Expert Consensus Statement
Epicardial Ablation For Ventricular Tachycardia
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