Case Study: Torch
Merge OEM adds imaging component to customer's cardiac interventional system
Custom engineering project combines Merge OEM's 3D visualization, surgical navigation and cardiac solution strengths
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A device OEM determined that the atrial fibrillation treatment application of its cardiac mapping and navigation system could be improved by enhancing the system's imaging capabilities.
In the OEM's existing product, treatment of atrial fibrillation entailed initial advancement of a set of ultrasound positioning (3) and ablation treatment catheters (1) into various cardiac structures. One catheter is positioned in the coronary sinus and other catheter is positioned in the bottom of the left ventricle. Under pulsed fluoroscopy guidance, a third positioning catheter and the treatment catheter are advanced through the septum into the left atrium. Another fluoroscopy period is used to guide the treatment catheter to atrium wall locations whose dysfunctional electrical activity is causing atrial fibrillation. Subsequently, the catheter's heating element ablates these atrial wall locations to neutralize the problem tissue. The method worked in practice, but to keep up with competitors the OEM wanted to integrate cardiac CT volumetric datasets to create a more sophisticated, less time-consuming option that exposed the patient to less fluoroscopy.
The OEM chose Merge OEM to supervise the system improvements by virtue of the company's long-time experience in 3D visualization, surgical navigation solutions and cardiology applications – combined with expertise in creating custom engineered solutions. The project was conducted using Merge OEM's methodology and a Rapid Application Development strategy that emphasized investigational and prototyping phases.
Merge engineers worked to develop an advanced algorithm that would provide precise 3D registration between the cardiac CT data and the catheter set intraoperatively, in addition to innovative and experimental 3D visualization techniques. The solution also included automated analysis of multiple anatomical and intra-cardiac structures, distances and proximity warnings.
Throughout the development process, successive iterations of the solution were subjected to surgical trials employing animal subjects. These studies helped Merge OEM validate workflow and functionality and to increase system accuracy to well within the required specifications.
The final result is an advanced, modernized atrial fibrillation treatment system that speeds up the procedure and lowers the x-ray exposure to patients and cardiac interventionalists.