FDA approves catheter-based systems that offer vascular access for hemodialysis
The FDA has approved marketing two catheter-based devices to connect to veins and arteries in patients with chronic kidney disease who need hemodialysis. (Source: Health News - UPI.com)
Source: Health News - UPI.com - June 25, 2018 Category: Consumer Health News Source Type: news
Austin medical device company gets FDA approval for kidney-disease treatment
TVA Medical Inc. has received federal authorization to sell a medical device that could change how people suffering from serious kidney disease receive treatment.
The Austin-based company announced June 22 that it has received "de novo" authorization from the U.S. Food and Drug Administration for its EverlinQ EndoAVF System, a minimally invasive piece of equipment that can give doctors hemodialysis access to a patient using magnetic catheters and radiofrequ ency energy. Once a person's kidneys can… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 25, 2018 Category: American Health Authors: Will Anderson Source Type: news
FDA OKs Two Devices for Endovascular AV Fistula Creation FDA OKs Two Devices for Endovascular AV Fistula Creation
The Ellipsys Vascular Access System and the everlinQ endoAVF System create arteriovenous fistulas percutaneously in patients with chronic kidney disease who need hemodialysis access.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 22, 2018 Category: Consumer Health News Tags: Nephrology News Alert Source Type: news
News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9 #medicaldevice
News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9 #medicaldevice (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 22, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news
FDA grants de novo clearance to hemodialysis catheters from Avenu Medical, TVA Medical
The FDA today granted de novo clearance to a pair of companies that make catheters designed for hemodialysis, Avenu Medical and TVA Medical.
The federal safety watchdog said the catheters are designed to create an arteriovenous fistula connecting veins and arteries for a less-invasive way to access the vascular system. Avenu’s device is called Ellipsys; TVA Medical makes the EverlinQ EndoAVF system.
“Dialysis is a necessary and life-saving procedure for thousands of individuals. With today’s action, there will be additional, less-invasive vascular access options for patients who will require hemodialysis...
Source: Mass Device - June 22, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Dialysis Food & Drug Administration (FDA) Regulatory/Compliance Avenu Medical TVA Medical Source Type: news
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
(Source: Food and Drug Administration)
Source: Food and Drug Administration - June 22, 2018 Category: American Health Source Type: news
Hemoglobin Concentration and Stroke Risk in Hemodialysis Hemoglobin Concentration and Stroke Risk in Hemodialysis
Might low hemoglobin concentrations contribute to the risk for hemorrhagic or ischemic stroke among hemodialysis patients?Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 13, 2018 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news
Fresenius Medical Care, Humacyte ink $150m strategic partnership deal
Fresenius Medical Care (NYSE:FMS; ETR:FRE) said today it inked a $150 million strategic partnership deal with Humacyte through which Fresenius will gain exclusive rights to commercialize Humacyte’s Humacyl bioengineered blood vessel technology.
Research Triangle Park, N.C.-based Humacyte is exploring the use of its Humacyl human acellular vessel as a conduit for hemodialysis in patients with end-stage renal disease who cannot have fistula placement.
Fresenius Medical will now be responsible for the marketing, sales and distribution of Humacyl following appropriate regulatory approval, the companies said. Fresenius ...
Source: Mass Device - June 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Vascular Fresenius Humacyte Source Type: news
FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
On June 7, 2018, the Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 7, 2018 Category: Drugs & Pharmacology Source Type: news
Baxter touts Theranova HDx dialysis tech study data
Baxter (NYSE:BAX) today released new data from studies exploring expanded hemodialysis with its Theranova dialyzer, touting the device’s ability to clear large middle molecules at a higher rate than standard hemodialysis and equal or faster removal rates compared to high-volume hemodiafiltration.
Results from a number of studies and poster presentations on the Theranova dialyzer were presented at the 55th Congress of the European Renal Association and European Dialysis and Transplant Association meeting this month, Baxter said.
The Deerfield, Ill.-based company’s Theranova dialyzer is designed to extend the range...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Dialysis Baxter Source Type: news
Pursuit Vascular wins expanded indication for antimicrobial device
ClearGuard HD antimicrobial caps [Image courtesy of Pursuit Vascular]Pursuit Vascular (Maple Grove, Minn.) today announced that it has won FDA clearance for a broader indication of its ClearGuard HD antimicrobial caps.
The new indication for the caps — used as an antimicrobial device for catheter-based dialysis patients — includes reduction in the incidence of central-line associated bloodstream infection in hemodialysis patients with central venous catheters.
Get the full story on our sister site Medical Design & Outsourcing.
The post Pursuit Vascular wins expanded indication for antimicrobial device appeared f...
Source: Mass Device - May 30, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: 510(k) Business/Financial News Catheters Dialysis Food & Drug Administration (FDA) News Well Regulatory/Compliance infections Pursuit Vascular Source Type: news
FDA Broadens ClearGuard(R) HD Antimicrobial Barrier Cap Indications
ClearGuard HD Caps Have Been Shown to Reduce Central Line-Associated Bloodstream Infections in Hemodialysis Patients
MAPLE GROVE, Minn., May 30, 2018 -- (Healthcare Sales & Marketing Network) -- Pursuit Vascular, Inc., manufacturer of ClearGuard HD Ant... Devices, FDA Pursuit Vascular, ClearGuard, Antimicrobial Barrier, hemodialysis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 30, 2018 Category: Pharmaceuticals Source Type: news
TrioxBio Announces Fast Track Designation Granted by U.S. FDA to Raviten(R) for the Treatment of Intradialytic Hypotension
Phase II clinical trials in patients undergoing hemodialysis to be initiated in Q4, 2018
NEWARK, Delaware, May 29, 2018 -- (Healthcare Sales & Marketing Network) -- TrioxBio Inc., a clinical-stage biopharmaceutical company specializing in the developme... Biopharmaceuticals, FDA TrioxBio, Raviten, ethylisothiouronium, Intradialytic Hypotension, hemodialysis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 29, 2018 Category: Pharmaceuticals Source Type: news
Moral Distress for Docs Providing Emergency - Only Hemodialysis
Docs describe burnout and emotional exhaustion; moral distress at seeing suffering and injustice (Source: The Doctors Lounge - Psychiatry)
Source: The Doctors Lounge - Psychiatry - May 22, 2018 Category: Psychiatry Tags: Endocrinology, Internal Medicine, Emergency Medicine, Nephrology, Nursing, Psychiatry, Journal, Source Type: news
A holistic approach to factors affecting depression in haemodialysis patients - Gerogianni G, Kouzoupis A, Grapsa E.
Depression in dialysis populations is affected by co-morbid diseases, such as cardiovascular disease, diabetes, and immune dysfunction, and it also includes high suicide risk and frequent hospitalizations. Depressive disorders have a close association with... (Source: SafetyLit)
Source: SafetyLit - May 22, 2018 Category: International Medicine & Public Health Tags: Suicide and Self-Harm Source Type: news
