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Topera Case Study

Cardiac Mapping Catheter for Rotor Modulation/Atrial Fibrillation.

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The Challenge

Topera, Inc. was a startup endeavor that had licensed technology for Focal Impulse and Rotor Modulation mapping software and had secured seed funding. The CEO was charged with creating a virtual team of medical device veterans to rapidly develop and commercialize the technology.

The Solution

Starting in late 2011, Rev.1 developed three different 64-electrode, “basket” mapping catheters that were deployed through a very small sheath, capable of navigating the coronary vessels to reach the chamber of the patient’s beating heart. Once within the heart, the basket electrode array expands outward, contacting the heart tissue, sensing and relaying the rogue electrical pulses. In just over 20 months, Rev.1 developed three distinct basket catheters, the workstation that runs the software and controls the device, and positioned Topera for regulatory submissions for CE mark and FDA approval. Rev.1 also developed and transferred the manufacturing line fixtures, documentation and procedures to international and domestic contract manufacturers.

“What we wanted to achieve was a breakthrough product and opportunity. We were a small startup with no in-house resources. REV·1 gave us a much higher degree of success. They delivered from cradle to market, taking on the entire project from the get-go to approval and transition to manufacturing. This was a complete product and project. REV·1 blended with our organization perfectly. We talked to other companies who said they could do this. They can’t.”