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Pfas Articles & Analysis

16 news found

What Are PFAS In Water & How Do They Affect Human Health?

What Are PFAS In Water & How Do They Affect Human Health?

Forever chemicals – also known as per and poly fluoralkyl substances (PFAS) – are a family of different compounds so called because of how they persist in the environment, with many (such as perfluorooctanoic acid and perfluorooctane sulfonic acid) associated with adverse effects in both animals and people. PFAS enjoy widespread use in a range of ...

ByH2O Building Services


McKinsey’s Values and Value Event to Feature Robert Chase of NewGen Surgical and Samantha Smith of Medtronic

McKinsey’s Values and Value Event to Feature Robert Chase of NewGen Surgical and Samantha Smith of Medtronic

NewGen Surgical products are California Prop 65 compliant; free of intentionally added BPA or BPA derived plastics, mercury, phthalates, PFAs, and PVC, and are USDA BioPreferred certified. Currently, the company offers 6 product lines, available direct or through major national distributors and internationally with approved CE mark. ...

ByNewGen Surgical


NewGen Surgical Earns USDA Certified Biobased Label On All Products

NewGen Surgical Earns USDA Certified Biobased Label On All Products

NewGen Surgical products are California Prop 65 compliant; free of intentionally added BPA or BPA derived plastics, mercury, phthalates, PFAs and PVC. Currently the company offers 6 product lines, available direct or through major national distributors and internationally with approved CE mark. ...

ByNewGen Surgical


NewGen Surgical Signs HHS Pledge to Mobilize Healthcare Sector to Reduce Emissions

NewGen Surgical Signs HHS Pledge to Mobilize Healthcare Sector to Reduce Emissions

NewGen Surgical products are California Prop 65 compliant; free of intentionally added BPA or BPA derived plastics, mercury, phthalates, PFAs and PVC. Currently the company offers 6 product lines, available direct or through major national distributors and internationally with approved CE mark. ...

ByNewGen Surgical


First Patients in the U.S. Enrolled in Biosense Webster Clinical Study To Evaluate VARIPULSE™ Catheter for Atrial Fibrillation

First Patients in the U.S. Enrolled in Biosense Webster Clinical Study To Evaluate VARIPULSE™ Catheter for Atrial Fibrillation

Johnson & Johnson MedTech* announced today that Biosense Webster, Inc., a worldwide leader in the science and technology of cardiac arrhythmia treatment, enrolled the first patients in its admIRE clinical study in the United States. admIRE is a prospective, multi-center, non-randomized study that will enroll more than 400 patients in the U.S. to evaluate the safety and effectiveness of ...

ByJohnson & Johnson Medical Devices Business Services, Inc.


Adagio Medical Announces Successful First-In-Human Cases of Pulsed Field Cryoablation for Treatment of Atrial Fibrillation

Adagio Medical Announces Successful First-In-Human Cases of Pulsed Field Cryoablation for Treatment of Atrial Fibrillation

The patients, a 32-year-old man with paroxysmal AF and a 60-year-old man with persistent AF underwent successful pulmonary vein and posterior wall isolation using a dedicated PFCA catheter powered by the proprietary Adagio iCLAS™ cryoablation and pulsed field ablation (PFA) consoles. “PFCA is a unique combination of Adagio’s ultra-low temperature cryoablation ...

ByAdagio Medical, Inc.


First-in-Human Trial of Pulsed Field Ablation with Kardium’s Globe® PF System

First-in-Human Trial of Pulsed Field Ablation with Kardium’s Globe® PF System

Pulsed field ablation is an innovative therapy that uses electric fields to treat heart tissue. PFA delivered by the Globe PF System is unique in that it achieves true single-shot isolation; a single application of the GlobePulse™ Waveform achieves pulmonary vein isolation (PVI) in as little as 3 seconds. ...

ByKardium Inc.


Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation

Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation

“The vision for pioneering Pulsed Field Ablation treatment was primarily due to PFA’s ability to have high-impact treatment while preserving healthy tissue. ...

ByAcutus Medical, Inc.


Adagio Medical Reports 85% Freedom from AF at 12 Months After a Single Ablation Procedure in Patients with Persistent Atrial Fibrillation and Presents Recent Developments of Pulsed Field Cryoablation Technology

Adagio Medical Reports 85% Freedom from AF at 12 Months After a Single Ablation Procedure in Patients with Persistent Atrial Fibrillation and Presents Recent Developments of Pulsed Field Cryoablation Technology

We have recently announced the initiation of the study in patients with monomorphic VT and are actively pursuing pulsed field cryoablation (PFCA), which combines ULTC and pulsed field ablation (PFA) technologies.” “There is a unique, physiologic synergy between ultra-low temperature cryoablation and pulsed field ablation,” said Dr. ...

ByAdagio Medical, Inc.


Boston Scientific Exercises Option to Acquire Farapulse, Inc.

Boston Scientific Exercises Option to Acquire Farapulse, Inc.

The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System – a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. ...

ByBoston Scientific


FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation

FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation

'The ADVENT Trial is uniquely positioned to change our field: it is not only the first pivotal trial of PFA but also the only randomized one approved to commence by the FDA. ...

ByBoston Scientific


FARAPULSE Receives European Approval To Commercialize Its Leading Pulsed Field Ablation System To Treat Paroxysmal Atrial Fibrillation

FARAPULSE Receives European Approval To Commercialize Its Leading Pulsed Field Ablation System To Treat Paroxysmal Atrial Fibrillation

("FARAPULSE" or "the Company") today announced that it has received the Conformite Europeene (CE) Mark for its FARAPULSE Pulsed Field Ablation (PFA) system for the treatment of Paroxysmal Atrial Fibrillation (AF). The approval makes FARAPULSE the first company in the world to commercialize a cardiac PFA system and permits marketing of the system across the ...

ByBoston Scientific


Kardium announces $115M in new financing for innovative atrial fibrillation treatment

Kardium announces $115M in new financing for innovative atrial fibrillation treatment

” The financing will also allow Kardium to begin additional clinical studies of a new version of the Globe System that uses pulsed field ablation (PFA), a new energy source for cardiac ablation. PFA has the potential to perform faster and safer ablations due to the non-thermal and tissue-selective nature of the energy source. ...

ByKardium Inc.


FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval

FARAPULSE’s Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval

Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial Fibrillation (AF). ...

ByBoston Scientific


Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.

Boston Scientific Announces Expanded Investment and Exclusive Acquisition Option Agreement with Farapulse, Inc.

Boston Scientific Corporation (NYSE: BSX) today announced it has signed an investment agreement with an exclusive option to acquire Farapulse, Inc., a privately-held company developing a pulsed field ablation (PFA) system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. This PFA system – comprising a sheath, generator and ...

ByBoston Scientific


EPA’s Actions to Restrict PFOA and Similar Chemicals Yield Significant Human Health and Environmental Benefits

EPA has also issued other Significant New Use Rules on perfluorinated chemicals, including perfluorooctane sulfonate (PFOS) and perfluoroalkyl sulfonates (PFAS) that were voluntarily phased-out of production. This proposal requires that anyone who intends to import these perfluorinated chemicals, including in products, or domestically produce or process these chemicals for any ...

ByUS EPA - Environmental Protection Agency

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