CardioFocus said yesterday it launched its HeartLight endoscopic ablation system in the U.S., touting that the 1st commercial procedure with the device had been performed at New York City’s Mount Sinai Hospital. The HeartLight system allows electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural […]
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 […]
CardioFocus said today it won FDA premarket approval for its HeartLight endoscopic ablation system, indicated for treating drug refractory recurrent symptomatic paroxysmal AF. The approval is based on data from a 353-patient, multi-center pivotal clinical study which met the primary safety and efficacy endpoints and reported freedom from paroxysmal AF at 12 months post-procedure, the Marlborough, […]
CardioFocus said today that the FDA accepted its pre-market approval application for the HeartLight visually-guided laser balloon ablation device for treating atrial fibrillation. The PMA bid, backed by data from a 353-patient pivotal study in which subjects were randomly assigned to treatment with either the laser balloon or standard radiofrequency ablation. The results, presented last May at the annual […]
CardioFocus this week reported a funding round worth nearly $32 million and said it inked a distribution deal in Japan for its HeartLight laser ablation system for treating atrial fibrillation.
Massachusetts-based medical device maker CardioFocus announced the launch of a new clinical trial of its HeartLight endoscopic ablation system for atrial fibrillation, this time spanning multiple centers across Europe.
CardioFocus added $11 million to its coffers in a round of debt financing from Oxford Finance and Silicon Valley Bank as it commercializes its HeartLight endoscopic ablation system overseas and winds up enrollment in a pivotal U.S. trial.
CardioFocus CRO Renny Clark said the funds will help the company prepare for its submission to the FDA for the HeartLight device, which combines an endoscope and a laser ablation device, according to a press release.
CardioFocus successfully treated the first patient in a pivotal trial of its HeartLight endoscopic ablation system for atrial fibrillation.
The HeartLight device is the first of its kind to to allow direct visualization of a beating heart in real time, without using radiation, to allow physicians to better aim delivery of ablation energy, according to a press release.