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.
MASSDEVICE WALL STREET ROUNDUP | One of Wall Street’s most notorious names raised its view of Covidien plc (NYSE:COV) today, setting a price target that’s 15 percent above yesterday’s closing price.
Although Goldman Sachs analysts stood pat on their “Buy” rating of the stock, which ended Monday at $52, they raised their price target to $60 and boosted the stock’s earnings estimate, ahead of the company’s plan to buy back up to 5 million shares of its own stock.
COV shares closed up 0.2 percent today at $52.08.
Omar Amirana, a partner at Oxford Biosciences, a life sciences VC firm that manages more than $1 billion in capital, will be pulling up anchor and moving over to Allied Minds, a “a private equity-funded innovation company.”
Allied Minds, which bills itself as “a holding company that creates subsidiary companies and supports them with capital, management, and shared services,” has offices in Boston and Los Angeles. The firm has over $250 million in assets and specializes in developing technology created at universities and research labs.
ImThera Medical Inc. said its tongue stimulation device for sleep apnea can improve patients’ snooze time.
The San Diego-based device maker concluded a European pilot study of its aura6000, an implanted neurostimulation device for treating obstructive sleep apnea (OSA) that delivers electrical pulses to the tongue during sleep.