CONTRACT MANUFACTURING
secrets of a
CMO What CardioFocus and Minnetronix learned over 16 years of partnership Earlier this year, CardioFocus wowed the market when it won pre-market approval from the FDA for its HeartLight system, an endoscopically guided light energy device for the treatment of atrial fibrillation. The minimally invasive ablation therapy is considered a major advance in treating afib because it allows surgeons to see the actual tissue they’re ablating. To date, more than 3,400 patients worldwide have been treated using the HeartLight device. “We’re still somewhat of a small company,” vice president of engineering Jerry Melsky says. ”Our core technology is delivering laser energy to the body in unique ways.”
That core tech is employed in HeartLight as a continuous, near-infrared laser light projected by the catheter, which heats the atrial tissue around the heart’s pulmonary vein, forming scar tissue that results in electrical isolation. The catheter works to create “conduction block” by allowing the physician to place overlapping arcs of laser light into the atrial wall around the vein. Complete isolation is often obtained with several 20-30 second energy deliveries, promising a great advantage in accuracy, speed and effectiveness in comparison with other catheter methodologies. Such state-of-the-art advances don’t happen overnight. In fact, CardioFocus has been working on the technology for more than 20 years, and found a partner in Minnetronix 16 years ago. You could say the two companies grew up together, sharing successes and challenges. What happened behind the scenes holds lessons for start-ups and established companies on the CMO and OEM sides of the aisle.
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