New frontiers in minimal invasive heart surgery
Over 24 million people across the EU and United States (US) are affected today by cardiac arrhythmias(opens in new window) and can highly benefit from the delivery of cardiac treatments directly on the outer surface of the heart. The tissue surrounding the heart – the pericardium(opens in new window) – is a delicate, double-walled pouch that shields the vital organ while lubricating its beating motion. Penetration of the pericardium tissue enables access to the surface of the heart (known as the pericardial space). Yet the current method risks damaging the heart muscle, as it requires using elongated needles pointed at the heart – which is in constant motion throughout the process. Complications happen in up to 30 % of the cases, with 10 % having severe life-threatening complications. This adds an extra EUR 1.7 billion a year in costs to European healthcare services and threatens patients’ lives. In the Horizon 2020-funded ViaOne project, the healthcare start-up CardioVia(opens in new window) has been developing and testing a safer method. The ViaOne is an innovative device allowing minimally invasive access to the outer surface of the heart. Once the ViaOne has penetrated the pericardium, the physician can insert a guidewire around the heart without harming it. The guidewire then allows a safe route for other instruments to enter and reach the relevant space. “During our research, we found to our surprise that this technique for accessing the outer surface of the heart has not changed in many years, and that it is a true pain for physicians,” says Ziv Menshes, CEO at CardioVia.
Gripping design
A mechanism at the device’s tip has a special texture that gently engages the tissue of the heart, allowing the tissue to be safely pulled away from the heart. The process is monitored by a smart pressure sensor that indicates to the physician when the device is properly positioned. This sensor also absorbs the forces coming from the moving heart, allowing the device’s tip to move freely along with the natural beating motion. With a gentle turn of the ViaOne controller, the pericardial tissue rises above the engagement element, reducing the risk of damage to the heart. ViaOne then makes a precise and controlled penetration through the outer layer of the pericardium within the shaft and inserts the guidewire through the device. ViaOne then serves as an anchored, hollow tube, allowing easy, controlled, secured, bi‐directional access to the heart. “Our simple, yet advanced technology utilises a hidden internal mechanism that ensures no needle is exposed at any time to the heart or any nearby organs, diminishing the risk of puncturing the heart,” says Menshes.
Forward motion
The ViaOne team spoke with physicians around the globe, including from China, the EU, India, Israel, Japan and the US. “We collected the most valuable information from the experience of highly skilled, well-known professionals. The team has also been meeting with heads of hospital units and received their great support,” says Menshes. The company is now focusing its efforts on completing clinical studies and attaining regulatory clearance from the EU (CE mark) and from the US FDA. “The heart is one of the most delicate and complicated instruments that the human body has, and it needs proper access and attention,” says Menshes.
