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
Terumo Neuro wins FDA nod for first dual-layer carotid stent
Terumo Neuro (formerly MicroVention) announced today that it received FDA premarket approval (PMA) for its Carotid Stent System. Aliso Viejo, California-based Terumo Neuro says this marks the first dual-layer micromesh carotid stent approved in the U.S. It offers physicians a clinically proven option to improve patient outcomes in carotid artery … [Read more...] about Terumo Neuro wins FDA nod for first dual-layer carotid stent
Imperative Care to kick off new trial of Zoom stroke treatment
Imperative Care announced today that it intends to fund a trial comparing its Zoom stroke system plus best medical treatment to treatment alone. Campbell, California–based Imperative Care designed Zoom for fast and effective clot removal from access through reperfusion. It treats patients with acute ischemic stroke, enabling smooth tracking … [Read more...] about Imperative Care to kick off new trial of Zoom stroke treatment
Spectrum Vascular bolsters executive team with new CEO, CCO
Spectrum Vascular announced today that it added to its executive team with the appointment of Ken Miller as CEO and Doug Shook as CCO. The company said its leadership appointments help advance its mission to deliver improved patient outcomes and scale impact. They build upon recent momentum, according to a news release, following a strategic … [Read more...] about Spectrum Vascular bolsters executive team with new CEO, CCO
Cagent Vascular initiates balloon angioplasty study
Cagent Vascular announced that it enrolled the first patient in a study comparing its Serranator system to plain old balloon angioplasty (POBA). The prospective, randomized (2:1 treatment to control) dual-center study plans to enroll up to 60 subjects. Investigators intend to use optical coherence tomography (OCT) imaging to demonstrate the … [Read more...] about Cagent Vascular initiates balloon angioplasty study
Merit Medical launches aortic access delivery system
Merit Medical Systems (Nasdaq:MMSI) announced that it launched the Ventrax delivery system for cardiac interventions. South Jordan, Utah-based Merit adds the latest delivery system to its growing electrophysiology (EP) and cardiac rhythm management (CRM) portfolio. It joins solutions such as HeartSpan, Worley, Prelude Snap and SafeGuard … [Read more...] about Merit Medical launches aortic access delivery system
