CardioFocus announced the completion of successful clinical cases with its QuickShot Nav large-area focal pulsed field ablation (PFA) catheter. Dr. Ante Anić performed the cases for the treatment of persistent AFib at KBC Split in Split, Croatia. They came as part of the Quick AF study evaluating the investigational PFA catheter. Anić serves as principal […]
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CardioFocus has positive pulsed field ablation data
CardioFocus today announced the publication of 12-month data from a study of its pulsed field ablation (PFA) system. ECLIPSE AF, evaluated the safety and performance of the CardioFocus Centauri system with commercial focal ablation catheters. The first-in-human study enrolled 82 patients treated across two centers in Europe. Centauri, which holds CE mark approval, remains investigational […]
CardioFocus completes first-in-human pulsed-field ablation case in investigational trial
CardioFocus announced today that investigators completed the first series of treatments in a study of its OptiShot pulsed-field ablation system. The VISION AF clinical trial evaluates OptiShot as a treatment for paroxysmal AFib. Dr. Vivek Reddy of Mount Sinai and Dr. Petr Neužil of Na Homolce Hospital (Prague) performed the first cases. The company expects […]
Design considerations you need to know when making ablation catheters to treat AFib
Catheters are increasingly deploying heart devices in minimally invasive procedures. CardioFocus VP of engineering Jerry Melsky describes the components and design considerations that go into making successful ablation catheters to treat AFib. Atrial fibrillation (AFib) is the most common irregular heart rhythm disorder. If the atria of the heart beats rapidly and irregularly, blood does […]
CardioFocus names new CFO
CardioFocus today said it appointed Stephan Ogilvie as chief financial officer. Prior to joining the Marlborough, Mass.-based company, Ogilvie served as managing director of healthcare investment banking at B Riley Securities. He has also served as VP of corporate development at Nuvasive and has held numerous leadership roles at ThinkEquity Partners, Lazard Capital Markets and Medtronic. […]
CardioFocus wins Japan regulatory approval for HeartLight X3 system
CardioFocus today said its HeartLight X3 catheter ablation technology received approval from the Japanese Ministry of Health, Labor and Welfare. Marlborough, Mass.-based CardioFocus designed the catheter ablation technology for controlled and consistent pulmonary vein isolation to treat atrial fibrillation (AFib). Get the full story on our sister site, Medical Tubing + Extrusion.
CardioFocus, China Grand Pharmaceutical partner to commercialize catheter ablation system in China
CardioFocus today announced a licensing and distribution agreement with China Grand Pharmaceutical to seek regulatory approvals for the HeartLight X3 catheter ablation technology in China. Marlborough, Mass.–based CardioFocus designed the HeartLight X3 system for controlled and consistent pulmonary vein isolation, which is the primary treatment for atrial fibrillation (AFib). Get the full story on our […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]
CardioFocus wins FDA approval for HeartLight X3 endoscopic ablation system
CardioFocus announced today that it received FDA approval for its next-generation HeartLight X3 endoscopic ablation system. Marlborough, Mass.-based CardioFocus’ system treats drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Last year, the company won CE Mark approval in Europe for the device and in February of this year, it announced that it sought out a PMA […]
CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system
CardioFocus is seeking a PMA supplement with FDA so that it can launch its next-gen HeartLight X3 endoscopic ablation system in the U.S. The move comes more than 10 months after Marlborough, Mass.–based won a CE Mark in Europe for the device, which is used to treat AFib. CardioFocus plans to launch HeartLight X3 in […]
CardioFocus names new CEO
CardioFocus announced today that its board of directors promoted chief operating officer Burke Barrett as its new CEO, effective Jan. 19, 2020. The 30-year veteran joined CardioFocus in 2002 and held roles ranging from vice president though president and COO, according to a news release. Before CardioFocus, Barrett served as VP of clinical operations at […]
