"APN Health has developed a highly effective and simple 3D cardiac mapping system that allows physicians to confidently perform interventional procedures that are critical for the treatment of heart rhythm disorders. Navik 3D uses technology that already exists in all electrophysiology labs, which makes it affordable to a greater number of hospitals and clinics around the world. Our goal is to make this important navigational tool widely available to help ensure the best outcomes for patients with cardiac arrhythmias."
APN Health, LLC is a new medical device company that has developed proprietary and patented software algorithms to create an innovative and cost-effective 3D cardiac imaging system called Navik 3D. These algorithms are capable of using real-time 2D fluoroscopic image data to locate the precise 3D x-y-z location of cardiac catheters. This information is then incorporated with other integrated algorithms and a display screen to create 3D maps that can be used for catheter mapping and ablation of cardiac arrhythmias.
APN Health's Navik 3D technology is driven by increasing global demand for heart rhythm disorder treatments in rapidly aging populations, which are expensive procedures. The current mapping systems capable of creating 3D cardiac maps can cost anywhere from $500,000 to $3 million. The disposable catheters required by these systems, which allow a cardiologist to locate and destroy the heart tissue that's causing the irregular beats, can cost more than $3,000 each.
Jasbir Sra, a cardiac electrophysiologist with Aurora Health Care in Milwaukee, Wisconsin, set out in 2010 to find a less-expensive approach, hoping to make cardiac ablation procedures more widely available, particularly in the developing world.
The Navik 3D system creates 3D maps of a heart chamber using basic patient monitoring and fluoroscopic imaging systems, which already exist in hospital catheter labs, at a fraction of the cost of other mapping products.
Future product expansion for APN Health includes the inevitable and planned extension of this technology for use in other procedures requiring 3D imaging, in areas such as orthopedics, neurosurgery, interventional radiology and cardiology.
In 2007 APN Health was incorporated by Dr. Jasbir Sra.
Initial prototypes were developed to evaluate the Navik3D technology.
NAVIK Predicate Device was identified and key product marketing goals were established.
Quality and Regulatory team was established with key electronic design history and electronic approval process was implemented.
Software Configuration Management using Visual Studio Team Foundation 2012 with automatic workflow to provide control on (1) task managements, (2) code checkin and (3) automated build processes were established.
Usability experience and risk control mitigation through design was incorporated into the software development of NAVIK3D.
Phase 1 of software development includes (1) Customer Requirements, (2) System Requirements, (3) Usability Requirements.
A working model of NAVIK3D prototype with real time data acquisition and processing & information rendering
Navik 3D™ is intended for catheter-based atrial and ventricular mapping using compatible catheters, and acquired data from compatible fluoroscopy systems and patient recording and monitoring systems. Navik 3D is intended to provide 3D location of these catheters from acquired 2D fluoroscopic images. The device allows real-time display of cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps and cardiac voltage maps.
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