CardioFocus readies HeartLight’s U.S. coming-out party at HRS 2016

Pre-market approval from the FDA in hand, CardioFocus is readying for a coming-out ball of sorts for its HeartLight cardiac visualization and ablation device at this week’s annual meeting of the Heart Rhythm Society in San Francisco. Chairman Paul LaViolette told MassDevice.com that Marlborough, Mass.-based CardioFocus is planning a selective U.S. launch for HeartLight starting in July. The device combines a balloon dilation catheter with a laser-based micro-endoscope and ablation device to allow electrophysiologists to see the tissue they’re targeting for ablation. “The nice thing that we offer is because we can see directly, we’re really conducting ablation under direct visualization. We don’t need complex electro-anatomical mapping as a result. We’re really doing an anatomical ablation, not electrical ablation, and it ultimately is actually quite an effective, standalone technology. It doesn’t really need to be integrated into the all of the other complex systems in the EP suite,” LaViolette told us. “That, frankly, enables us to commercialize as a standalone company without having to offer a very broad product line of there ancillary, EP technologies.” The April 1 FDA approval came earlier than expected, said LaViolette, formerly the longtime operations chief at Boston Scientific (NYSE:BSX), who’s now a managing partner & COO at venture capital shop SV Life Sciences. “It’s actually quite ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Catheters Wall Street Beat CardioFocus Inc. HRS 2016 newtag Source Type: news