In February, after years of development, the FDA granted 510k clearance to APN Health LLC to market their Navik 3D system for treating cardiac arrhythmia. The biotech startup came about because the founder, Jasbir Sra, wanted to provide a less-expensive way for developing nations to perform ablation on dysfunctional heart tissue. Physicians use ablation to treat supraventricular tachycardia and sometimes atrial fibrillation which affects almost 10% of people in the U.S. over age 65.
After spending $15 million and writing a million lines of code, the electrophysiologist and his team are ready to begin testing their platform at Aurora St. Luke’s Medical Center in Milwaukee, Wisconsin.
Because conventional ablation procedures only produce a 2D images of the heart, there is some risk of damaging healthy heart tissue. Sra’s team wanted to employ 3D mapping to more precisely locate the problematical heart tissue and the catheter used to destroy it. To make sure the technology was affordable, they wanted to operate with standard patient monitoring and fluoroscopic imaging equipment commonly found in hospital electrophysiology labs
In order to isolate the heart tissue causing the arrhythmia, a catheter containing sensors measures electrical signals from specific areas in the heart, each signal correlating with a place in 3-D space. Meanwhile, the fluoroscopic imaging system follows the catheter’s movements in 2-D. The APN technology combines the catheter images with the signal and calculates catheter size to create a 3-D color-coded map showing the electrical activity and misfiring area of the heart chamber.
The Navik system includes a workstation and iPad to display real-time 3-D maps in various formats, including cardiac anatomical maps, electrical activation maps and voltage maps. The company holds 13 patents with more in the works.
Early in the development phase, the startup hired a well-regarded San Francisco consulting firm that helped foster a positive relationship with the FDA whom they first met with in 2013. The Navik FDA application was 10,000 pages.
In today’s economy, startups like APN Health have opportunity to tap into highly specialized skill sets once limited to large corporations. Sra’s conception transitioned into a marketable technology because a virtual team of mathematicians, engineers and physicists spread throughout the U.S. and India solved complicated math and engineering challenges.
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