Cordis announced new data from two major peripheral studies evaluating its Selution SLR drug-eluting balloon. The Miami Lakes, Florida-based company presented 12-month results from the SUCCESS PTA study at the Charing Cross Symposium in London. It then shared SELUTION SFA Japan three-year results today at the Japan Endovascular Treatment … [Read more...] about Cordis shares positive study results from multiple drug-eluting balloon studies
Technologies & Devices
Boston Scientific has positive Farapulse, Farapoint data
Boston Scientific today announced positive 12-month study results for its Farapulse pulsed field ablation (PFA) system. The company reported primary endpoints results from the second phase of ADVANTAGE AF, with findings published in Circulation. Investigators presented key findings at the second annual PFA Live Case Summit in San … [Read more...] about Boston Scientific has positive Farapulse, Farapoint data
Perfuze completes enrollment in stroke catheter study, appoints VP of sales
Perfuze announced today that it completed enrollment in its U.S. FDA investigational exemption (IDE) trial evaluating its stroke treatment. Galway, Ireland-based Perfuze also announced a new personnel appointment, naming Joe Rotger EVP of sales. According to a news release, Perfuze completed enrollment in the MARRS (millipede aspiration for … [Read more...] about Perfuze completes enrollment in stroke catheter study, appoints VP of sales
Field Medical raises $40M Series A for pulsed field ablation tech
Field Medical announced that it closed a Series A financing round worth $40 million to support its pulsed field ablation (PFA) technology. Cardiff-by-the-Sea, California–based Field Medical was founded by Dr. Steven Mickelsen, the founder of Farapulse. Mickelsen also serves as CEO. He led his previous PFA technology developer to an acquisition … [Read more...] about Field Medical raises $40M Series A for pulsed field ablation tech
FDA says Q’Apel aspiration system recall is Class I following discontinuation
Q’Apel Medical announced that the FDA classified a voluntary recall of its 072 Aspiration System as Class I, the most serious kind. The company earlier this year initiated a discontinuation and recall of the system, also known as "Hippo," which includes "Cheetah." It recalled 1,617 units of the Hippo system after receiving an FDA warning letter. … [Read more...] about FDA says Q’Apel aspiration system recall is Class I following discontinuation
BD warns on intravascular catheter
The FDA shared an alert that BD (NYSE: BDX) and its Bard subsidiary warned customers of an issue with certain intravascular catheters. BD recommended the removal of certain unused PowerPICC intravascular catheters from use or sale. In-use PowerPICC intravascular catheters also received updated instructions for use. Affected products include the … [Read more...] about BD warns on intravascular catheter
Conavi warns on intravascular catheter issue
The FDA today issued an alert related to a potentially high-risk device issue with certain Conavi Novasight Hybrid catheters. Its communication comes as part of its pilot to enhance the medical device recall program. The FDA said it became aware of the issue after Conavi sent a letter to affected customers recommending the removal of certain … [Read more...] about Conavi warns on intravascular catheter issue
Imricor kicks off first-in-human ventricular ablation trial
Imricor Medical Systems announced that it commenced a trial by completing its first-in-human ventricular ablation procedure. Guided by real-time MRI through the company's NorthStar Mapping System, the case took place at Amsterdam University Medical Centre. Imricor says the procedure marked several world firsts, including the first ventricular … [Read more...] about Imricor kicks off first-in-human ventricular ablation trial
Adagio Medical wins FDA breakthrough nod for cryoablation tech
Adagio Medical (Nasdaq:ADGM) announced today that it received FDA breakthrough device designation for its vCLAS cryoablation system. The Laguna Hills, California-based company based its vCLAS cryoablation catheter on its proprietary ultra-low cryoablation technology (ULCT). It aims to address the challenges of ventricular tachycardia (VT) … [Read more...] about Adagio Medical wins FDA breakthrough nod for cryoablation tech
CardioFocus reports successful pulsed field ablation cases
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 … [Read more...] about CardioFocus reports successful pulsed field ablation cases
