central venous catheter News
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FDA grants new QIDP Designation Status for BTX 1801
Botanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801. This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central ...
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Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer System Procedure
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid Services (CMS) has finalized a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification (APC) assignment ...
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Bluegrass Vascular Announces New Paper Reporting Ability to Eliminate Use of a Femoral Catheter with the Surfacer System
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a case report demonstrating the ability to utilize the Surfacer® System to perform the Inside-Out® procedure and obtain right-sided central venous access in a patient with central venous occlusion and ...
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Bluegrass Vascular Announces Publication of Surfacer System SAVE Registry Results
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of the results from the company’s prospective, multicenter SAVE (Surfacer® System to Facilitate Access in VEnous Occlusions) Registry in the Journal of Vascular and Interventional ...
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Bluegrass Vascular Technologies Announces Publication of Surfacer System IDE Study Results
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of the results of its prospective, multicenter SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) study in the Journal of Vascular Access. This ...
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Bluegrass Vascular Announces Publication Reporting Long-term data following facilitation of HeRO graft placement using the Surfacer System
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a report three cases where the Surfacer System was used to help facilitate the placement of the HeRO graft in patients with thoracic central venous obstruction (TCVO) where other methods for crossing the ...
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Bluegrass Vascular Announces Publication Reporting Experience with Cardiac Resynchronization Therapy Device Lead Placement following Use of Surfacer System
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a report documenting the clinical utility of the Surfacer System to gain venous access prior to the placement of cardiac resynchronization therapy (CRT) device leads in a patient with obstructed central veins. ...
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Bluegrass Vascular Announces Featured Paper in the Journal of Vascular Surgery Reporting on the Use of the Surfacer System
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a paper featured on the cover of the June 2022 issue of the Journal of Vascular Surgery (JVS) which reports on the use the Surfacer System to perform an Inside-Out® procedure to obtain central venous ...
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Bluegrass Vascular Announces New Paper Reporting Use of the Surfacer System via Transcollateral Approach
Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of a paper reporting on the use of the Surfacer® System to perform the Inside-Out® procedure via transcollateral approach. “The Surfacer Inside-out system represents a new approach to restore ...
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Bluegrass Vascular Closes $5 Million Convertible Debt Financing
Privately held Bluegrass Vascular Technologies, a leading innovator and global manufacturer of lifesaving devices and methods based on the Inside-Out® vascular access procedure, today announced the closing of a $5.0 million financing in convertible promissory notes to a group of qualified investors, including new investors and existing shareholders who participated in previous capital raises. ...
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FDA Grants the Hemolung® De Novo Clearance
PITTSBURGH – (BUSINESS WIRE) – November 15, 2021 – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company De Novo clearance for the Hemolung Respiratory Assist System. The Hemolung ...
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New Study Shows Advantages of Ellipsys System in Safely and Quickly Creating Reliable Dialysis Access
A new study shows significant benefits of the Ellipsys Vascular Access System in easily and safely creating durable vascular access for end-stage renal disease (ESRD) patients who require hemodialysis. It also offers a standardized process for using the minimally invasive technology that other physicians can follow to reproduce the results, which “will make it easier for more practitioners ...
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