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Dialysis Treatment Articles & Analysis: Older

10 news found

Alnylam Announces FDA Approval of Supplemental New Drug Application for OXLUMO® (lumasiran) in Advanced Primary Hyperoxaluria Type 1

Alnylam Announces FDA Approval of Supplemental New Drug Application for OXLUMO® (lumasiran) in Advanced Primary Hyperoxaluria Type 1

The FDA approval is based on positive six-month results from the ILLUMINATE-C Phase 3 study, in which OXLUMO treatment resulted in substantial reductions in POx and demonstrated an encouraging safety and tolerability profile in patients with compromised renal function, including those with kidney failure and undergoing treatment by hemodialysis. ...

ByAlnylam Pharmaceuticals, Inc.


Major Biomedical Catalyst grant win

Major Biomedical Catalyst grant win

There are currently 3.3 million haemodialysis patients worldwide who receive treatment multiple times a week. Dialysis treatment can reduce life expectancy by two thirds and almost half of patients die from cardiovascular complications, in part caused by the immune system reacting to components of the dialysis apparatus. The ...

ByInvizius Limited


Tablo Hemodialysis System Cartridge Receives FDA 510(k) Clearance Enabling Production in North America

Tablo Hemodialysis System Cartridge Receives FDA 510(k) Clearance Enabling Production in North America

(Nasdaq: OM) (“Outset”), a medical technology company reducing the cost and complexity of dialysis, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a new sterilization method of the cartridge utilized in its Tablo® Hemodialysis System, enabling full production in North America. The Tablo cartridge is a single-use ...

ByOutset Medical


Outset Medical Named to Fast Company’s First-Ever List of the Next Big Things in Tech

Outset Medical Named to Fast Company’s First-Ever List of the Next Big Things in Tech

View the full release here: https://www.businesswire.com/news/home/20211118005835/en/ Outset is reinventing how dialysis is delivered to patients. Specifically designed to simplify dialysis treatment for patients and providers, the Tablo® Hemodialysis System is a first-of-its-kind enterprise solution that is approved for use across the ...

ByOutset Medical


Dicerna Presents PHYOX™2 and Primary Hyperoxaluria Healthcare Utilization Data at American Society of Nephrology (ASN) Kidney Week 2021

Dicerna Presents PHYOX™2 and Primary Hyperoxaluria Healthcare Utilization Data at American Society of Nephrology (ASN) Kidney Week 2021

These data underscore the potential of nedosiran to be a meaningful treatment option for those affected by PH1, if approved.” Separately, findings from a real-world study examining de-identified electronic medical record (EMR) data, including demographics, clinical characteristics and healthcare utilization among 47 patients with PH pre- and post-dialysis ...

ByNovo Nordisk A/S


CloudCath Announces Collaboration with American Renal Associates in Pre-Market Clinical Study for Peritoneal Dialysis Patients Innovative Remote Monitoring Platform Will Be Tested for In-Home Use

CloudCath Announces Collaboration with American Renal Associates in Pre-Market Clinical Study for Peritoneal Dialysis Patients Innovative Remote Monitoring Platform Will Be Tested for In-Home Use

CloudCath, developer of a remote monitoring and predictive analytics platform for catheter-based treatments, today announced a collaboration with American Renal Associates (ARA), a leading provider of outpatient dialysis services. In a U.S.- based, pre-market clinical study, ARA will evaluate the use of CloudCath’s System by peritoneal ...

ByCloudCath


Invizius announces £5.3m Series A

Invizius announces £5.3m Series A

For particularly ill patients with COVID-19, the virus can cause acute kidney failure which can eventually turn into chronic kidney failure – with the only treatment options being either lifelong dialysis or a kidney transplant. ...

ByInvizius Limited


Ellipsys System Offers Significant Advantages for Creating Dialysis Access, Physicians Say

Ellipsys System Offers Significant Advantages for Creating Dialysis Access, Physicians Say

The Ellipsys® Vascular Access System enables patients with kidney failure to start dialysis treatment sooner with fewer procedures, complications and interventions compared to surgery, according to several leading physicians who spoke at the recent meeting of the American Society of Diagnostic and Interventional Nephrology (ASDIN). ...

ByMedtronic


Two-year Ellipsys data featured at annual Controversies in Dialysis Access (CiDA) Meeting

Two-year Ellipsys data featured at annual Controversies in Dialysis Access (CiDA) Meeting

A landmark two-year follow-up study on the Ellipsys® Vascular Access System was highlighted at the annual Controversies in Dialysis Access (CiDA) meeting, one of the premier dialysis access medical conferences in the world. ...

ByMedtronic


SKI Vascular Center is First Ambulatory Surgical Center in the Nation to Utilize FDA-Approved Ellipsys System for Non-Surgical Dialysis Fistula Creation

SKI Vascular Center is First Ambulatory Surgical Center in the Nation to Utilize FDA-Approved Ellipsys System for Non-Surgical Dialysis Fistula Creation

A significant advancement for dialysis patients and clinicians, the Ellipsys System, developed by Avenu Medical (San Juan Capistrano, CA), transforms an open surgery connecting an artery to a vein into a minimally invasive procedure using a needle and a catheter. ...

ByMedtronic

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