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

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 d...
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

Moral Distress for Docs Providing Emergency-Only Hemodialysis
TUESDAY, May 22, 2018 -- Clinicians who provide emergency-only hemodialysis (EOHD) to undocumented immigrants experience moral distress and professional burnout, according to a study published online May 22 in the Annals of Internal Medicine. Noting... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 22, 2018 Category: Pharmaceuticals Source Type: news

Physicians report feeling moral distress over hospital policies that force inadequate care
(American College of Physicians) Clinicians in safety-net hospitals describe feeling moral distress and being driven toward professional burnout because of policies that prevent them from performing hemodialysis to undocumented immigrants, except in the case of an emergency. Being forced to provide inferior care due to the patient's immigration status was a significant burden to the clinicians who reported feeling a sense of admiration for these patients and a desire to advocate on their behalf. (Source: EurekAlert! - Social and Behavioral Science)
Source: EurekAlert! - Social and Behavioral Science - May 21, 2018 Category: International Medicine & Public Health Source Type: news

Mortality in Patients on Hemodiafiltration vs Hemodialysis Mortality in Patients on Hemodiafiltration vs Hemodialysis
Might hemodiafiltration patients realize better outcomes than those receiving hemodialysis?Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 16, 2018 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

Making Dialysis Safer for Patients: Tools to Prevent Infections in Hemodialysis
May 18, 2018 2:00-3:15pm ET. (Source: HSR Information Central)
Source: HSR Information Central - May 8, 2018 Category: International Medicine & Public Health Source Type: news

Access to hemodialysis technology: From Toronto to Addis Ababa
(Source: St. Michael's Hospital News and Media)
Source: St. Michael's Hospital News and Media - May 2, 2018 Category: Hospital Management Tags: Hospital News Source Type: news

Opioids Tied to Adverse Outcomes in Hemodialysis Patients
THURSDAY, April 19, 2018 -- For patients on hemodialysis, opioids are associated with adverse outcomes, according to a study published online April 19 in the Clinical Journal of the American Society of Nephrology. Julie H. Ishida, M.D., from the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 19, 2018 Category: Pharmaceuticals Source Type: news

Antifreeze poisoning : the case of a  patient with repeated ethylene glycol poisoning - Prinz J, Böll B, von Bergwelt M, Burst V, Becker JU, Carvalho-Fiel D, Shimabukuro-Vornhagen A, Kochanek M.
Ethylene glycol poisoning of incidental or suicidal intention can cause life-threatening metabolic acidosis, diverse secondary damage, and even lead to death. Beside hemodialysis effective therapy consists of the administration of fomepizole and ethanol. W... (Source: SafetyLit)
Source: SafetyLit - April 16, 2018 Category: International Medicine & Public Health Tags: Home and Consumer Product Safety Source Type: news

CVS is diving into the dialysis market
Drug store operator CVS Health (NYSE:CVS) said today it plans to expand into the dialysis market, launching a program focused on early identification of kidney disease and unveiling plans to develop a new home hemodialysis system. CVS said it will approach its entry into the dialysis market in stages, focusing on early disease identification and education, followed by the development of a home dialysis program for both hemodialysis and peritoneal dialysis. As part of its program, the company said it will launch a pivotal trial of a new home hemodialysis system in support of planned FDA submission, though it has not ye...
Source: Mass Device - April 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development CVS Health Source Type: news

Notes from the Field: False-Negative Hepatitis B Surface Antigen Test Results in a Hemodialysis Patient — Nebraska, 2017
(Source: CDC Morbidity and Mortality Weekly Report)
Source: CDC Morbidity and Mortality Weekly Report - March 15, 2018 Category: American Health Source Type: news

Genetic Variants Linked to Earlier Kidney Failure in African Americans
African Americans with APOL1 gene experience faster rate of decline in kidney function and begin hemodialysis at a younger age versus those without the gene. (Source: NIDDK News)
Source: NIDDK News - March 15, 2018 Category: Endocrinology Source Type: news

Humacyte closes $75m Series C round
Humacyte said today that it raised $75 million in a Series C preferred stock financing, led by a group of existing private investors and new investors. The Research Triangle Park, N.C.-based company expects to use its newly-acquired funds to support an on-going Phase III pivotal study evaluating its human acellular vessel, Humacyl, as a conduit for hemodialysis in patients with end-stage renal disease who cannot have fistula placement. Humacyte finished enrolling participants in the 350-patient trial last September and anticipates 12-month post-implantation data to be available in the third quarter of 2018. The company als...
Source: Mass Device - March 12, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Funding Roundup Vascular Humacyte Inc. Source Type: news

Pomalidomide/Dexamethasone Effective in R/R Myeloma With Renal Insufficiency
Nearly 80% of R/R myeloma patients with severe renal impairment requiring hemodialysis achieved disease control with this treatment combination. (Source: CancerNetwork)
Source: CancerNetwork - February 28, 2018 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Hematologic Malignancies Multiple Myeloma Source Type: news

Wearable Artificial Kidney Could be Game Changer
Most innovations medicine occur by asking one simple question. Is there a better way? Physicians at the Kidney Research Institute of the University of Washington have asked that question about hemodialysis treatments – lengthy procedures that filter a patient’s blood when the kidneys no longer function properly. The institute is developing a wearable artificial kidney that could completely change the paradigm for some of these patients with impaired kidney function. Earlier this week, at MD&M West, Jonathan Himmelfarb, MD, who servers as director of the Kidney Research Institute, spoke about the develo...
Source: MDDI - February 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Medical Device Business Source Type: news

WHO calls for sustainable solution to health sector power shortages in Gaza
8 February, 2018, Gaza Strip – Gaza’s health sector was on the verge of collapse due to dwindling fuel supplies until the United Arab Emirates stepped in this week with a US$2 million grant to sustain hospital backup generators for critical health services. The donation will provide enough fuel to keep facilities running for several months.  “The UAE’s timely support will save lives, but a more sustainable solution is required to address the chronic fuel and power shortages in Gaza that leave health facilities consistently on the verge of closure,” says Dr. Gerald Rockenschaub, Head of W...
Source: WHO EMRO News - February 8, 2018 Category: Middle East Health Source Type: news

TVA Medical touts meta-analysis of everlinQ endoAVF treatments
TVA Medical today released data from a meta-analysis study of its everlinQ endovascular arteriovenous fistula system designed for hemodialysis access, touting a high procedure success rate and a high rate of fistula maturation. Results from the 236-patient trial were presented at the Leipzig Interventional Course 2018, the Austin, Texas-based company said. Data in the meta-analysis came from four clinical studies and 79 commercial cases, and indicated a 96.8% and 97.8% procedure success rate in clinical studies and real-world cases, respectively, as well as an acceptable safety profile. The results also indicated 88% fistu...
Source: Mass Device - February 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular TVA Medical Source Type: news