Search Results for “dialysis” – media

Outset Medical gets FDA nod for dialysis accessory months after halting sales

Dive Brief Outset Medical received 510(k) clearance for TabloCart with prefiltration, an accessory that filters sediment and minerals out of water before it enters the company’s dialysis machines. Outset stopped distributing the accessory last year after receiving a warning letter in July 2023 from the Food and Drug Administration stating that it needed 510(k) clearance. BTIG analyst Marie Thibault wrote in a research note that the clearance is a “big win” for Outset, adding that she expects the company to now be able to work through a customer backlog. Dive Insight San Jose, California-based Outset is competing in the market for dialysis equipment. Its Tablo hemodialysis system can be used in acute or chronic care facilities and was cleared for home use in 2020. The company also makes an accessory for the system, called TabloCart, which includes wheels, storage drawers, and water prefiltration to remove sediment and minerals from supply ...
- Source: drugdu
- 81
- May 9, 2024
FDA Approves Akebia’s Vafseo for Anemia in Adults with Chronic Kidney Disease on Dialysis

Don Tracy, Associate Editor Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan in adults with chronic kidney disease.Akebia Therapeutics announced that the FDA has approved Vafsen (vadadustat) for the treatment of anemia in adults with chronic kidney disease (CKD) who are on dialysis. According to a company press release, the once-daily, oral tablet works as a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, activating the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. In other words, it copies the body’s response to low oxygen levels. The FDA based the approval was on positive outcomes from the INNO2VATE program and additional safety data from its use in Japan, where it was launched in August 2020. Now approved in 37 countries, Akebia stated that Vafsen has the potential to improve overall outcomes for patients struggling with ...
- Source: drugdu
- 149
- March 30, 2024
Comprehensive protein analysis reveals potential targets for treating dialysis-related amyloidosis

Dialysis patients often develop dialysis-related amyloidosis and exhibit bone and joint disorders that impair their activity of daily living. Blood purification devices consisting of hexadecyl-immobilized cellulose beads aimed at removing the precursor protein, β2- microglobulin (β2-m), are used in the treatment of dialysis-related amyloidosis. Dr. Yamamoto et al. investigated that comprehensive analysis of proteins adsorbed onto blood purification devices revealed the identification of 200 types of proteins, including β2-m. Among these, several molecules, such as lysozyme, were shown to be involved in amyloid fibril formation. I. Background of the study Patients with advanced chronic kidney disease (CKD) require kidney replacement therapy, such as hemodialysis, to manage their condition. Hemodialysis patients often experience various symptoms, leading to a compromised quality of life and reduced activity levels. Itching is a common symptom frequently observed in hemodialysis patients. Although its exact causes remain unclear, a survey conducted in Japan in 2000 found that ...
- Source: drugdu
- 133
- March 4, 2024
After Novo’s Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. But dialysis bigwig DaVita—whose future business could be on the line—is making its skepticism known. Based on the inclusion criteria for CKD patients in Novo Nordisk’s FLOW trial, which stopped early this week after hitting pre-specified criteria for efficacy, DaVita believes there may only be “limited application” of the findings to the overall CKD population. DaVita, which shares a significant chunk of the dialysis industry with its German rival Fresenius, admitted it’s “nearly impossible” to draw any conclusions from Novo’s study at this point, given that the detailed results are still under wraps. Emboldened by Ozempic’s performance thus far, Novo on Wednesday said it would begin powering down FLOW on the advice of the study’s independent data monitoring committee. The company expects the ...
- Source: drugdu
- 134
- October 14, 2023
Medtronic’s dialysis device recall assigned to Class I by the FDA

Dive Brief Medtronic’s recall of hemodialysis catheters was categorized by the U.S. Food and Drug Administration as a Class I event, according to a Friday entry in the FDA’s database. The company contacted customers in June after routine manufacturing testing identified a blockage that could obstruct the catheter, potentially delaying treatment and leading to outcomes such as blood clots and the destruction of red blood cells. Healthcare providers with devices covered by the recall should immediately quarantine and stop use of the catheters. Medtronic has received no confirmed complaints related to the problem, and no reports of adverse events or deaths. Dive Insight The Medtronic recall affects specific lots of Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple Lumen Catheters. Medtronic’s Mahurkar Elite Catheters are unaffected by the recall. “Medtronic initiated a voluntary recall related to Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple ...
- Source: drugdu
- 146
- August 18, 2023
Identifying, educating patients are essential to successful peritoneal dialysis programs

Beginning or growing a peritoneal dialysis program requires knowledgeable staff who can reach as many potential patient candidates as possible, according to a speaker at ASN Kidney Week. “A successful PD program is a program that can offer PD to the widest possible range of patients and not only can a successful program offer PD to these patients, but it can maintain these patients on PD to maximally realize their goals of care,” Brendan McCormick, MD, FRCPC, associate professor at the University of Ottawa and medical director of home dialysis at the Ottawa Hospital, said during the meeting, which was held as a virtual event. Nephrologists, nurses and other health care team members can most easily identify potential candidates in chronic kidney disease programs, but it is important to avoid overlooking patients in the hospital, McCormick said. Educating potential candidates is a key component. Effective education requires knowledgeable staff and ...
- Source: drugdu
- 174
- October 29, 2020
educating patients
This Artificial Kidney Eliminates The Need For Kidney Dialysis

It is estimated by The National Kidney Foundation that over 100,000 patients are on the waiting list for kidney donors. A further 3,000 names are added to the list every year. An average patient has to wait for 3.6 years for a viable transplant. The patients are treated with dialysis while they are waiting for a transplant and only one in three patients survive for more than five years without a transplant. All that could change as scientists have developed the world’s first artificial kidney.
- Source: wonderfulengineering
- 473
- November 20, 2017
artificial kidney Market Views
Stent Tek Closes Series A Investment Round for its ePATH AVF Device, Aiming to Improve Vascular Access for Haemodialysis

Stent Tek, a medical device company that is developing a minimally invasive catheter system for dialysis patients, announced today it has successfully closed a Series A funding round with investments from two institutional investors.
- Source: prnewswire
- 587
- September 8, 2017
catheter invasive Market Views Series
Stent Tek Closes Series A Investment Round for its ePATH AVF Device, Aiming to Improve Vascular Access for Hemodialysis

Stent Tek, a medical device company that is developing a minimally invasive catheter system for dialysis patients, announced today it has successfully closed a Series A funding round with investments from two institutional investors.
- Source: infomeddnews
- 406
- September 1, 2017
dialysis Market Views Stent Tek
Global Hemodialysis Consumables Market Analysis

As the most potential market in china, Hemodialysis market appears a large revenue space. With the opening of private hemodialysis services, private economy in the hemodialysis industry is about to take a ”Golden era”.
- Source: Ddu
- 591
- June 24, 2017
hemodialysis consumables Market Reports

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