Renal dialysis

Baxter Announces U.S. FDA 510(k) Clearance of AK 98 Hemodialysis Machine

Retrieved on: 
Friday, March 12, 2021

Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (FDA) clearance of its next-generation Artificial Kidney 98 (AK 98) dialysis machine, which is designed to be a portable and easy-to-use system to administer hemodialysis (HD) treatments.

Key Points: 
  • Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (FDA) clearance of its next-generation Artificial Kidney 98 (AK 98) dialysis machine, which is designed to be a portable and easy-to-use system to administer hemodialysis (HD) treatments.
  • The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25kg or more.
  • This release includes forward-looking statements concerning the AK 98 dialysis machine and Theranova, including anticipated availability and potential benefits associated with their use.
  • Baxter, AK 98 and Theranova are registered trademarks of Baxter International Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210312005084/en/

Christiansen Joins Renalogic, Brings Powerhouse Experience as The Industry Undergoes Transformational Change

Retrieved on: 
Wednesday, March 10, 2021

Today, Renalogic has grown to offer the industrys most comprehensive approach to reducing massive risks associated with Chronic Kidney Disease (CKD) and dialysis.

Key Points: 
  • Today, Renalogic has grown to offer the industrys most comprehensive approach to reducing massive risks associated with Chronic Kidney Disease (CKD) and dialysis.
  • Hes been a trusted advisor for so long, its difficult to overstate Johns contributions to the industry regarding ERISA, self-funded plans, and risk management.
  • The next five years of industry transformation will determine the next 50 years for health plans facing catastrophic dialysis claims.
  • Christiansen, who began his law career in 1985, has a combined emphasis on self-insured health plans and health information technology issues.

Dialysis Patient Citizens Commends Reintroduction of the Jack Reynolds Memorial Medigap Expansion Act

Retrieved on: 
Tuesday, March 9, 2021

WASHINGTON, March 9, 2021 /PRNewswire/ --Dialysis Patient Citizens (DPC) released the following statement today thanking Congresswomen Cynthia Axne (D-IA-03) and Jaime Herrera Beutler (R-WA-03) for introducing the Jack Reynolds Memorial Medigap Expansion Act in honor of founding DPC Board member and longest-serving president Jack Reynolds.

Key Points: 
  • WASHINGTON, March 9, 2021 /PRNewswire/ --Dialysis Patient Citizens (DPC) released the following statement today thanking Congresswomen Cynthia Axne (D-IA-03) and Jaime Herrera Beutler (R-WA-03) for introducing the Jack Reynolds Memorial Medigap Expansion Act in honor of founding DPC Board member and longest-serving president Jack Reynolds.
  • For Jack, he was only four years old when he was injured, and 22 when his kidneys began to fail.
  • "We commend Representatives Axne and Herrera Beutler for introducing the Jack Reynolds Memorial Medigap Expansion Act and recognizing the continued need to assist the hundreds of thousands of Americans suffering with kidney disease," said DPC Board President Andrew Conkling.
  • A founding Board member and the longest-serving president of Dialysis Patient Citizens, Jack credited a large part of his longevity during his 45 years on dialysis to the financial security he felt due to having access to Medigap coverage.

Dialyze Direct Expands SNF Home Dialysis Program to Kentucky

Retrieved on: 
Monday, March 8, 2021

"Over the past few months, we have had the privilege of working closely with the Kentucky Department of Health by participating in their pilot program for SNF home hemodialysis," said Josh Rothenberg, Dialyze Direct's Chief Operating Officer.

Key Points: 
  • "Over the past few months, we have had the privilege of working closely with the Kentucky Department of Health by participating in their pilot program for SNF home hemodialysis," said Josh Rothenberg, Dialyze Direct's Chief Operating Officer.
  • Dialyze Direct provides comprehensive, turn-key home dialysis solutions that allow patients with end-stage renal disease (ESRD) to take advantage of the latest in patient-centric dialysis care.
  • Kentuckymarks the eleventh state in which Dialyze Direct is active, with expansion slated for several additional states within the next year.
  • Dialyze Direct has operations inFlorida,Illinois,Indiana,Kentucky, Maryland,New Jersey,New York,Ohio,Pennsylvania,Tennessee, and Texas and is in the process of launching operations in additional states.

Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus

Retrieved on: 
Monday, March 8, 2021

We are delighted that the FDA accepted and granted Priority Review for this breakthrough therapy.

Key Points: 
  • We are delighted that the FDA accepted and granted Priority Review for this breakthrough therapy.
  • Pruritus in hemodialysis patients is a debilitating condition with a significant impact on quality of life and increased risk for hospitalization and mortality.
  • We are highly committed to bringing this important new treatment to patients in the US as soon as possible following FDA approval, together with our partner Cara Therapeutics, commented Stefan Schulze, CEO of Vifor Pharma Group.
  • The FDA acceptance for filing and granting of Priority Review for the KORSUVA NDA marks a significant milestone for Cara and for the substantial number of hemodialysis patients with chronic intractable pruritus, said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics.

ERAS 2021: CHF Solutions to Host On-Demand Presentation on Management of Fluid Overload in Cardiac Surgery Patients

Retrieved on: 
Thursday, March 4, 2021

He will discuss the morbidity and mortality issues surrounding fluid overload in patients undergoing cardiac surgery, the cardio-renal connection, and how to best manage these patients.

Key Points: 
  • He will discuss the morbidity and mortality issues surrounding fluid overload in patients undergoing cardiac surgery, the cardio-renal connection, and how to best manage these patients.
  • Fluid overload is extremely common after cardiac procedures and can lead to ongoing cardio-renal complications.
  • CHF Solutions, Inc. (Nasdaq: CHFS) is a medical device company dedicated to changing the lives of patients suffering from fluid overload with its novel ultrafiltration therapy system.
  • The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload).

Mohawk Valley Health System Brings Leading Kidney Care and Dialysis Organization U.S. Renal Care to Community

Retrieved on: 
Tuesday, March 2, 2021

2, 2021 /PRNewswire/ --The Mohawk Valley Health System (MVHS) is pleased to announce it has entered into an agreement with U.S. Renal Care (USRC) to enhance and grow the dialysis services in the community.

Key Points: 
  • 2, 2021 /PRNewswire/ --The Mohawk Valley Health System (MVHS) is pleased to announce it has entered into an agreement with U.S. Renal Care (USRC) to enhance and grow the dialysis services in the community.
  • Mohawk Valley Health System and U.S. Renal Care (USRC) to enhance dialysis services in the community.
  • U.S. Renal Care partners with the nation's top nephrologists to build operational infrastructures that allow clinicians to focus on delivering the highest quality patient care.
  • U.S. Renal Care intends to invest significantly in enhancing the patient experience and improving clinical outcomes for the kidney care population of Mohawk Valley by implementing technology advancements and purchasing new dialysis equipment including new dialysis machines and water treatment systems.

VenoStent Announces $2.3M in Seed Funding to Transform Vascular Access Surgery for Hemodialysis Patients

Retrieved on: 
Tuesday, February 23, 2021

The product is aimed to eliminate vascular surgery failures, at first targeting vascular access surgery required to initiate hemodialysis treatment for end-stage renal disease (ESRD) patients.

Key Points: 
  • The product is aimed to eliminate vascular surgery failures, at first targeting vascular access surgery required to initiate hemodialysis treatment for end-stage renal disease (ESRD) patients.
  • Our bioengineered solution has the potential to transform the lives of these patients," said Tim Boire, Ph.D., VenoStent's Co-Founder and CEO.
  • However, dialysis itself is not without difficulties: vascular access surgery required to initiate hemodialysis have a 55-65% failure rate.
  • Its first product, SelfWrap, is a slip-on, bioresorbable wrap aimed to eliminate vascular access surgery failure rate of 55-65% in hemodialysis patients.

Global Hemodialysis and Peritoneal Dialysis Market (2020 to 2027) - by Product, Type, and End-user - ResearchAndMarkets.com

Retrieved on: 
Monday, February 22, 2021

The "Hemodialysis and Peritoneal Dialysis Market by Product, Type, and End User - Global Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Hemodialysis and Peritoneal Dialysis Market by Product, Type, and End User - Global Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.
  • Based on the peritoneal dialysis product type, the consumables segment is estimated to account for the largest share of this market in 2020.
  • The large share of this segment is mainly attributed to the requirement of peritoneal dialysis consumables for both types of peritoneal dialysis.
  • North America is estimated to command the largest share of the hemodialysis and peritoneal dialysis market in 2020, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

Rockwell Medical Announces U.S. Availability of Triferic® AVNU for Replacement of Iron and Maintenance of Hemoglobin in Patients on Hemodialysis

Retrieved on: 
Tuesday, February 9, 2021

Triferic is a novel, physiologic iron maintenance therapy that provides bioavailable iron to replace iron lost during every dialysis treatment and maintain hemoglobin.

Key Points: 
  • Triferic is a novel, physiologic iron maintenance therapy that provides bioavailable iron to replace iron lost during every dialysis treatment and maintain hemoglobin.
  • Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment.
  • Triferic and Triferic AVNU address a significant medical need in treating functional iron deficiency in end-stage kidney disease patients.
  • Triferic is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office.