AQUAHeart
Treating Atrial Fibrillation with Single-Shot Catheter Technology

Atrial fibrillation (A-fib), characterized by irregular and rapid heart rhythm, is problematic, particularly in people over 65. A-fib can lead to heart failure and cause an increase in the occurrence of strokes. Research indicates that of the 100 million people in the world who suffer from atrial fibrillation, only about 1 million are treated with ablation. This is because heart ablations require cardiac labs, expensive equipment, 3D mapping systems, and experts to perform the procedure.

To democratize heart ablations, AQUAHeart® is the only single shot High Power Short Duration (HPSD) tool, that combines the power of steam energy and balloon applications. It has a patented double balloon design for safe, fast, and complete ablation to treat atrial fibrillation on a larger scale. Using Pulmonary Vein Insulation (PVI), a catheter connected to an ablation system is inserted into the left atrium of the heart through the groin to the area that needs to be ablated. There is an outer and inner balloon, where the inner balloon is inflated with steam and the outer balloon insulates blood from the heat. A hot zone is created at the area of contact between the two balloons and thermal energy from the inner balloon passes through the outer balloon to ablate the pulmonary vein ostia.

AQUAHeart removes the need for 3D mapping as well as high-end labs to perform more complex procedures.

This increases the pool of potential sites and reduces the treatment time, enabling more patients to be treated. Moreover, the technology could allow interventional cardiologists to perform the procedure, increasing the number of potential therapists. The device is easy to use and comes with an automated energy delivery system to speed up patient treatment. It is currently in the advanced stage of the development and regulatory approval process.

In its testing stage, AQUAHeart has performed pre-clinical trials in their labs and has obtained positive results, with no thermal blood coagulation or collateral organ damage observed. They produced the entire ablation process in six or seven seconds, faster than the time required by competing techniques.

In the future, we might have a close loop system where automatic feedback from heart signals suggest starting or ending the therapy

“In the future, we might have a close loop system where automatic feedback from heart signals suggest starting or ending the therapy,” says Dr. Holger Friedrich, CEO of AQUAHeart. This will enable individualization of the therapy to the patients and their conditions. The device will go into first in human trials in 2024 with approx. 20 patients initially, most likely in Europe, with 6 months follow-up with the endpoint being safety, efficacy, and freedom from AF.

By collaborating with their cardiology advisors once the first device is introduced, AQUAHeart plans to launch follow-up devices based on the technology. With the use of specialized catheters, the company’s goal is to treat various elements of cardiac arrhythmia. According to the inventors, their innovation should be perceived as a “platform technology,” that is simple, safe, and quick to use.