Laugh it off: Even simulated laughter improves your mood
(Natural News) People say that a sense of humor makes life’s troubles easier to bear. However, according to the results of a study, implementing a one-of-a-kind simulated laughter program may also help boost the overall health of an individual who requires hemodialysis. The authors posit that this special program may help improve the quality of life and... (Source: NaturalNews.com)
Source: NaturalNews.com - November 5, 2018 Category: Consumer Health News Source Type: news

Uninsured Patients Experience Delays in Obtaining Arteriovenous Access for Hemodialysis Uninsured Patients Experience Delays in Obtaining Arteriovenous Access for Hemodialysis
Uninsured patients who start in-center hemodialysis with a central venous catheter are less likely than those already on Medicare or Medicaid to obtain arteriovenous fistulas (AVF) or grafts (AVG) by their fourth month of dialysis, when they become Medicare eligible, according to a new study.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 5, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

ASN: High-Dose, Proactive IV Iron Noninferior in Hemodialysis
THURSDAY, Nov. 1, 2018 -- For patients undergoing maintenance hemodialysis, a high-dose intravenous iron regimen administered proactively is noninferior to a low-dose intravenous iron regimen administered reactively, according to a study published... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 1, 2018 Category: Pharmaceuticals Source Type: news

Another Hold up for NxStage ’s Merger with Fresenius
Fresenius Medical Care’s $2 billion acquisition of Waltham, MA-based NxStage Medical has been delayed yet again. The Bad Homburg, Germany-based company made plans to pick up NxStage in August of 2017 and the deal was supposed to close sometime this year. However, NxStage said in a regulatory filing that the pending merger could come in February of 2019. The issue around the delay seems to center around Fair Trade Commission concerns. Earlier this year, to help satisfy FTC’s antitrade concerns surrounding the deal, NxStage sold its Blood Lines business to B.Braun for an undisclosed sum. &...
Source: MDDI - November 1, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

ASN: Home Dialysis Associated With Improved Survival
MONDAY, Oct. 29, 2018 -- Home hemodialysis (HHD) is associated with better survival than in-center hemodialysis (IHD) among incident dialysis patients, according to a study presented at the American Society of Nephrology's Kidney Week, held Oct. 23... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 29, 2018 Category: Pharmaceuticals Source Type: news

High-Dose Iron an Option for Maintenance Hemodialysis
(MedPage Today) -- High-dose noninferior to low-dose, required less erythropoiesis-stimulating agent (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - October 29, 2018 Category: Hematology Source Type: news

Home Hemodialysis Tied to Better Survival in Incident Patients
(MedPage Today) -- Patient's ages (Source: MedPage Today Nephrology)
Source: MedPage Today Nephrology - October 28, 2018 Category: Urology & Nephrology Source Type: news

Prevalence of depression in Jordanian hemodialysis patients - Awwa IAA, Jallad SG.
Background: Although depression is recognized as the most common psychiatric disorder in hemodialysis patients with a significant negative impact on management and prognosis, we didn ’t find any previous data regarding its prevalence in Jordanian patients... (Source: SafetyLit)
Source: SafetyLit - October 27, 2018 Category: International Medicine & Public Health Tags: Ergonomics, Human Factors, Anthropometrics, Physiology Source Type: news

Fresenius Medical touts Crit-Line hemodialysis fluid management studies
Fresenius Medical Care‘s (NYSE:FMS) renal therapies group today released results from four studies of its Crit-Line monitor that looked to explore the relation between relative blood volume monitoring (RBV-M) and patient outcomes. Data from the studies were presented at the 2018 American Society of Nephrology’s Kidney Week Symposium in San Diego, Calif. Results from two of the studies indicated that managing fluid with RBV-M resulted in reduced hospitalizations for patients new to hemodialysis, and provided a “positive return on investment,” according to a press release. A retrospective database ana...
Source: Mass Device - October 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Fresenius Source Type: news

High-Dose Iron Safe, Effective in Hemodialysis Patients High-Dose Iron Safe, Effective in Hemodialysis Patients
High-dose iron reduces the amount of erythropoiesis-stimulating agent needed to treat dialysis patients with anemia, with no rise in risk for infection or cardiovascular events, new research shows.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 26, 2018 Category: Consumer Health News Tags: Nephrology News Source Type: news

Humacyte launches Phase II vascular trauma Humacyl vessel trial
Humacyte said yesterday it launched a U.S. Phase II trial of its Humacyl investigational human acellular vessel exploring the systems’ use for vascular replacement or reconstruction in patients with life or limb-threatening vascular trauma. The Research Triangle Park, N.C.-based company said it hopes to enroll 40 adult patients at six U.S. sites for the trial, with patient monitoring extending out to 24 months. “As a world leader in trauma research, we are constantly exploring new and innovative approaches to treating life threatening injuries. We look forward to evaluating this bioengineered blood vessel in th...
Source: Mass Device - October 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Featured Vascular Humacyte Source Type: news

NxStage touts home hemodialysis study data
NxStage Medical (NSDQ:NXTM) today released data from a study comparing home hemodialysis to traditional treatment in a skilled nursing facility, touting a lower risk of death and cardiovascular hospitalization for those treated more often with home hemodialysis. Full results from the trial are slated to be presented at the American Society of Nephrology Kidney Week 2018 Annual Meeting next week, the Lawrence, Mass.-based company said. Investigators analyzed data collected from 3,619 patients treated in skilled nursing facilities between 2011 and 2015, and found that patients treated more frequently at home experienced...
Source: Mass Device - October 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials NxStage Medical Inc. Source Type: news

Vascular Therapies raises $12m for drug-eluting vascular access implant
Vascular Therapies has raised $12.4 million from 29 investors as part of a $21.1 million round, according to a document filed last week with the SEC. The Cresskill, N.J.-based company is developing a sirolimus-eluting collagen implant for patients with end-stage renal disease. The bioresorbable drug-delivery system is designed to keep open a portal of entry into a patient’s vascular system for hemodialysis. Get the full story at our sister site, Drug Delivery Business News. The post Vascular Therapies raises $12m for drug-eluting vascular access implant appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 15, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Featured Funding Roundup Pharmaceuticals Vascular vasculartherapies Source Type: news

Ultrasound Can Predict Success of AV Fistula for Hemodialysis
Blood flow, diameter, and depth predict unassisted, overall maturation (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - October 12, 2018 Category: Cancer & Oncology Tags: Nephrology, Oncology, Radiology, Surgery, Journal, Source Type: news

Ultrasound Can Predict Success of AV Fistula for Hemodialysis
FRIDAY, Oct. 12, 2018 -- Detection of arteriovenous fistula (AVF) blood flow, diameter, and depth on ultrasound can predict AVF clinical maturation, according to a study published online Oct. 11 in the Journal of the American Society of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 12, 2018 Category: Pharmaceuticals Source Type: news

Study: Online positive psychology exercises improve quality of life in hemodialysis patients
(University of Illinois at Urbana-Champaign) Patients with depression who used tablet computers to complete brief positive psychology exercises online several times a week scored lower on depressive symptoms and reported that they felt better able to cope with their kidney disease by the end of the five-week pilot study, led by University of Illinois social work professor Rosalba Hernandez. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 10, 2018 Category: International Medicine & Public Health Source Type: news

Rockwell Medical Appoints VP, Strategic Accounts
WIXOM, Mich., Oct. 1, 2018 -- (Healthcare Sales & Marketing Network) -- Rockwell Medical, Inc. (NASDAQ: RMTI) (the "Company" or "Rockwell Medical") today announced that Anne Boardman has been appointed Vice President, Strategic Account... Biopharmaceuticals, Personnel Rockwell Medical, Triferic, ferric pyrophosphate, hemodialysis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 1, 2018 Category: Pharmaceuticals Source Type: news

Ethanol locks in catheters for dialysis may prevent sepsis
This Expert commentary, of a meta-analysis that reported ethanol lock is effective in reducing catheter-related bloodstream infection in haemodialysis patients, notes that further research is required before specific recommendations on ethanol locks can be made. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - September 28, 2018 Category: Consumer Health News Source Type: news

What Causes Hyperkalemia?
Discussion Potassium (K+) is an alkali metal (Group 1 of periodic table with Hydrogen, Lithium and Sodium) with an anatomic number of 19. Its chemical symbol K, comes from the medieval Latin, kalium which means potash (mainly potassium carbonate or potassium hydroxide), the substance it was first isolated from. Potassium is an important cation and it mainly resides in the intracellular fluid with only a small amount in the extracellular fluid. Potassium regulates cell volume, pH and enzyme functions. Hyperkalemia is defined as a potassium level> 5.5 mEq/L in children and> 6.0 mEq/L in newborns. Hyperkalemia incre...
Source: PediatricEducation.org - September 24, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

Antimicrobial lock solutions for preventing catheterrelated infections in haemodialysis
This systematic review of 39 studies (n=4216) found antibiotic antimicrobial and combined (antibiotic ‐non antibiotic) lock solutions (LSs) decreased incidence of catheter‐related infection compared to control LSs. The effect on thrombosis incidence is uncertain for all antimicrobial LSs. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - September 12, 2018 Category: Consumer Health News Source Type: news

How sensors are helping hemodialysis move into the home
Providing advanced medical care in a patient’s home once required the help of trained professionals. No longer – new sensor technology is enabling a massive migration from hospitals to home care environments. Outset Medical’s Tablo home hemodialysis platform features a streamlined touchscreen interface and a small size. But the real core of its effectiveness lies in its sensors. [Image courtesy of Outset Medical] Medtech is on the move again. New technological advances are enabling systems that have, for years, been shackled to hospitals and clinics, to travel home with their users. For decades, hemo...
Source: Mass Device - September 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Dialysis mHealth (Mobile Health) Outset Medical teconnectivity Source Type: news

Investors & #039; Faith in Outset Overwhelming with Whopping $132M round
When Leslie Trigg took the helm of Outset Medical in 2013, she helped lead a $60 million series B round. The San Jose-based company was also working to get the Tablo Hemodialysis system, a device that simplifies dialysis procedures, on the market. But oh, how things have changed. Outset Medical has seen Tablo gain a nod from the FDA in 2015 and has even seen a surge in investor and consumer interest in the device. Earlier this week, Outset Medical executives revealed the company closed on a $132 million a series D equity round. The round was backed by some heavy hitters and led by new investor Mubadala Investment Company, ...
Source: MDDI - August 29, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Outset Medical closes $132m Series D funding round
Outset Medical said today it raised $132 million in a Series D round of equity financing, with funds slated to accelerate the commercial expansion of its Tablo hemodialysis system. The San Jose, Calif.-based company develops and produces the Tablo hemodialysis system, an all-in-1 dialysis machine designed to handle water purification and dialysate production and be used in a variety of different settings. The round was led by the newly invested Mubadala Investment Company and joined by existing investors Baxter Ventures, Fidelity Management and Research Company, Partner Fund Management LP, Perceptive Advisors, funds advise...
Source: Mass Device - August 28, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Funding Roundup Outset Medical Source Type: news

Vascular Graft Solutions ’ aneurysm graft used in hemodialysis patients
  Vascular Graft Solutions’ Frame external support Vascular Graft Solutions has reported the first clinical use of its Frame external support technology in high-flow arteriovenous (AV) fistulas. The first five cases were performed by Dr. Vladimir Matoussevitch from Cologne University Hospital in Germany. The braided cobalt chrome, kink-resistant external support was designed for autologous vein grafts in bypass or reconstruction of peripheral arterial blood vessels. Mattoussevitch used them to prevent high-flow AV fistula and aneurysmal enlargement complications, which are common in patients undergoing...
Source: Mass Device - August 20, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Vascular vasculargraftsolutions Source Type: news

Dialysis Linked to Dementia in Seniors
TUESDAY, Aug. 14, 2018 -- Older kidney failure patients on hemodialysis have high rates of dementia, which is associated with an increased risk of early death, a new study shows. Researchers analyzed data from nearly 357,000 dialysis patients aged... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 14, 2018 Category: General Medicine Source Type: news

Variation in the Hemodialysis Access Journey and Its Burden Variation in the Hemodialysis Access Journey and Its Burden
In what ways do the wide variations in hemodialysis access methods used impact individual patients?Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 13, 2018 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

The Effect of Online Hemodiafiltration on Nutritional Status The Effect of Online Hemodiafiltration on Nutritional Status
What additional benefits might high-volume online hemodiafiltration offer over conventional hemodialysis?Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 30, 2018 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

Do You Know How to Manage Japan ’s Revised Reimbursement Approach?
One significant change in Japan’s revised reimbursement process for new medical devices involves pricing. Applicants have been required for some time to provide pricing for their medical devices in other primary markets such as the United States, the United Kingdom, Germany, France, and Australia. Pricing has been based on list price, not market price, and the intention was to cap the reimbursement of medical devices. Given the typical differences between U.S. pricing and European pricing, the high U.S. price tended to pull the average up. (Please see the example below in Table 1; each price is converted ...
Source: MDDI - July 27, 2018 Category: Medical Devices Authors: Keisuke Suzuki Tags: Regulatory and Compliance Source Type: news

Baxter shares dip despite Q2 earnings beat
Shares in Baxter (NYSE:BAX) have fallen slightly today despite the medical giant beating expectations on Wall Street with its second quarter earnings results. The Deerfield, Ill.-based company posted profits of $343 million, or 63¢ per share, on sales of $2.8 billion for the three months ended June 30, seeing profits grow 29.4% while sales grew 9.1% compared with the same period last year. Adjusted to exclude one-time items, earnings per share were 77¢, just ahead of the 71¢ expectations on Wall Street where analysts expected too see sales of $2.8 million, which the company met. “Our solid second ...
Source: Mass Device - July 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Baxter Source Type: news

B. Braun to Pick Up NxStage ’s Bloodlines Business
Braun Medical is set to acquire NxStage Medical’s bloodlines business. The potential acquisition is subject to Federal Trade Commission approval and is contingent upon the closing of the $2 billion merger between NxStage and Waltham, MA-based Fresenius Medical Holdings. The bloodlines business is operated under the Medisystems name. “We are pleased to add the Streamlinebloodline to our dialysis product portfolio,” Sam Amory, Vice President of B. Braun Medical, said in a release. “Although we have been selling Streamline for many years, this acquisition will allow us to more broadly promote Streamlin...
Source: MDDI - July 20, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

B Braun inks deal to buy NxStage ’ s bloodlines biz
B. Braun said today it inked a deal to acquire the NxStage Medical‘s (NSDQ:NXTM) bloodlines business, which operates under the Medisystems moniker. Bethlehem, Penn.-based B. Braun did not release any details of the acquisition, and has not revealed how it plans to integrate the business into its existing product lines. “We are pleased to add the Streamline bloodline to our dialysis product portfolio. Although we have been selling Streamline for many years, this acquisition will allow us to more broadly promote Streamline’s benefits as part of our transformative system of products, which includes...
Source: Mass Device - July 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions B. Braun NxStage Medical Inc. Source Type: news

Top symptoms of aluminum poisoning and toxicity
(Natural News) Exposure to high levels of aluminum may lead to potentially harmful toxicity. Old age and reduced kidney function are two most common risk factors associated with aluminum poisoning. According to an article published in Medscape.com, aluminum toxicity is commonly found in patients with renal impairment. Long-term hemodialysis is also linked to increased odds of aluminum... (Source: NaturalNews.com)
Source: NaturalNews.com - July 14, 2018 Category: Consumer Health News Source Type: news

BD closes TVA Medical buy
Becton Dickinson (NYSE:BDX) wasted no time in closing the cash buyout of  TVA Medical, which just a few weeks ago landed FDA clearance for its EverlinQ EndoAVF hemodialysis device, for an undisclosed amount. Austin, Texas-based TVA won de novo clearance June 22 for the EverlinQ EndoAVF device, which uses a pair of magnetic catheters and radiofrequency energy to create an arteriovenous fistula for hemodialysis access without open surgery. BD said today that it plans to change the system’s name to WavelinQ EndoAVF as it integrates TVA into its peripheral intervention business. “The FDA’s...
Source: Mass Device - July 9, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Dialysis Mergers & Acquisitions bectondickinson TVA Medical Source Type: news

$65B global giant Becton Dickinson buys Austin company making life easier for those with kidney disease
Becton Dickinson and Co., or BD, has purchased Austin medical-device company TVA Medical Inc. Financial terms were not disclosed but the deal hands control of a small company in the Texas capital's medical-technology world to a global player with annual revenue in the 11 figures. It's an exit sure to be watched by other local medical-device companies such as Ortho Kinematics Inc. and Alaf air Biosciences Inc. TVA Medical, founded in 2009, makes it easier for doctors to create hemodialysis access,… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - July 9, 2018 Category: Pharmaceuticals Authors: Will Anderson Source Type: news

Fresenius Medical Care offers $585m in notes
Fresenius Medical Care (NYSE:FMS; ETR:FRE) this week successfully placed notes with an aggregate principal amount of €500 million ($584.9 million). The notes will mature in 7 years and have an annual coupon of 1.5%, the company noted. Fresenius reported that the issue price is 99.704% and the resulting yield amounts to 1.545%. “The transaction was very well received by investors and substantially oversubscribed. The proceeds will be used for general corporate purposes, including the refinancing of upcoming maturities,” Fresenius said in a press release. Last week, the medtech giant inked a $150 m...
Source: Mass Device - July 5, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Dialysis Funding Roundup Wall Street Beat Fresenius Source Type: news

FDA Permits Marketing of Devices to Create Arteriovenous Fistula
TUESDAY, July 3, 2018 -- The U.S. Food and Drug Administration has permitted marketing of two catheter-based devices designed to create an arteriovenous (AV) fistula in patients with chronic kidney disease in need of hemodialysis. The devices are... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 3, 2018 Category: Pharmaceuticals Source Type: news

Few Hemodialysis Patients on Medicare Enroll in Hospice
WEDNESDAY, June 27, 2018 -- Among Medicare beneficiaries on hemodialysis, few patients are enrolled in hospice at the end of life, regardless of the spending trajectory during the last year of life, according to a study published in the June issue... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 27, 2018 Category: Pharmaceuticals Source Type: news

Ellipsys & #039; FDA Nod Is a Major Turning Point for Hemodialysis
A new catheter-based technology could provide a non-surgical option for arteriovenous (AV) fistula creation. FDA recently gave de novo clearance to Avenu Medical’s Ellipsys Vascular Access System. The San Juan Capistrano, CA-based company’s device challenges the surgical option to create an AV fistula, which has been the gold standard for about 50 years. “This is what we call a disruptive technology for sure,” Ed Chang, Co-Founder, Director and VP Marketing for Avenu, told MD+DI. “We liken this to lap chole. Prior to lap chole it was always done surgically. That was the gold standard until lap...
Source: MDDI - June 27, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

FDA grants de novo clearance to Avenu Medical for Ellipsys vascular access system
Vascular access system maker Avenu Medical said today it won FDA de novo clearance for its Ellipsys vascular access system designed for use with end-stage renal disease patients who require hemodialysis. The San Juan Capistrano, Calif.-based company touted that its Ellipsys EndoAVF technology acts as an alternative to traditional AV fistula creation. The system, which can be used under local or regional anesthesia, uses an ultrasound-guided catheter that delivers a small amount of thermal energy to fuse a permanent anastomosis between the vein and artery to create an AVF. “Using the Ellipsys vascular access...
Source: Mass Device - June 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Avenu Medical Source Type: news

A Tool for Incremental Hemodialysis Prescription A Tool for Incremental Hemodialysis Prescription
A new, easy to use spreadsheet may be a helpful tool for the prescription of incremental hemodialysis.Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 27, 2018 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

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 hemodial...
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. Fr...
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 exte...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Dialysis Baxter Source Type: news