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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

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

Comprehensive up-to-date review of toxic alcohol poisoning
3.5 out of 5 stars Toxic Alcohols. Kraut JA, Mullins ME. N Engl J Med 2018 Jan 18;378:270-280. Reference This is a good general review and update of clinical issues regarding the major toxic alcohols: methanol, ethylene glycol, isopropanol, diethylene glycol, and propylene glycol. The article is chockablock with information, and would I think be somewhat difficult to follow if one was not already familiar with these agents. For those wishing to learn the subject de novo, a good introductory book chapter in a toxicology or emergency medicine text would be better. But this is a very good refresher for those already...
Source: The Poison Review - January 30, 2018 Category: Toxicology Authors: Leon Gussow Tags: Medical diethylene glycol isopropanol methanol propylene glycol Review toxic alcohol Source Type: news

Serious fall injury history and adverse health outcomes after initiating hemodialysis among older U.S. adults - Bowling CB, Hall R, Khakharia A, Franch HA, Plantinga LC.
BACKGROUND: Although older adults with pre-dialysis chronic kidney disease (CKD) are at higher risk for falls, the prognostic significance of a serious fall injury prior to dialysis initiation has not been well described in the end-stage renal disease popu... (Source: SafetyLit)
Source: SafetyLit - January 22, 2018 Category: International Medicine & Public Health Tags: Age: Elder Adults Source Type: news

Laminate Medical launches study of VasQ hemodialysis fistula device
Laminate Medical Technologies said today it launched a pivotal, FDA-cleared trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis. The Israel-based company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure. The device regulates flow by constraining and shaping the fistula and reinforces and shields the perianastomotic vein against high pressure, wall tension and flow levels, the company said. The first procedures in the trial were recently perform...
Source: Mass Device - January 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Vascular Laminate Medical Technologies Source Type: news

Baxter subsidiary sues B. Braun over blood filtration system
Baxter (NYSE:BAX) and its subsidiary Gambro filed a patent infringement lawsuit against B. Braun last week, claiming that the German medical device maker’s Omni blood purification system infringes on seven of the patents covering Baxter’s Prismaflex system. The devices are used to treat patients who have acute kidney injuries and need help filtering out the waste products that accumulate in the blood. Both the Omni system and the Prismaflex system deliver continuous renal replacement therapy – a form of hemodialysis where the patient’s blood is removed and processed through a hemofilter. B...
Source: Mass Device - January 18, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Legal News Wall Street Beat B. Braun Baxter Gambro Source Type: news

Bluegrass Vascular launches pivotal study for Surfacer vascular access catheter
Bluegrass Vascular Technologies said it enrolled the first patients in a pivotal trial of its Surfacer “inside-out” vascular access catheter. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union in August 2016; Bluegrass later inked an EU distribution deal with Merit Medical (NSDQ:MMSI) that included an equity stake. Surfacer is designed to be threaded through the femoral vein up to and into blockages in the jugular, which acts as a stabi...
Source: Mass Device - January 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Vascular Bluegrass Vascular Technologies Source Type: news

Autogenous Conduits for Leg Bypass Surgery Used Less Often in Female Dialysis Patients Autogenous Conduits for Leg Bypass Surgery Used Less Often in Female Dialysis Patients
Autogenous conduits improve patency in hemodialysis patients undergoing lower-extremity bypass surgery, but are used less often in women than in men, new research shows.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - January 8, 2018 Category: Surgery Tags: General Surgery News Source Type: news

These lab-grown blood vessel replacements could benefit dialysis patients
[Image from University of Minnesota]University of Minnesota researchers have developed a blood vessel replacement made of biological materials in a lab. The lab-grown vessels have no living cells at implantation and could be used as a graft for kidney dialysis patients. The lab-engineered blood vessel replacement is the first nonsynthetic, decellularized graft that is repopulated with cells using the recipient’s cells when implanted. The grafts could also be used as coronary and peripheral bypass blood vessel and tubular heart valves. Approximately 480,000 people are on dialysis in the U.S., according to the National...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Implants Regenerative Medicine Research & Development kidney dialysis MedTech University of Minnesota Source Type: news

Emergency-Only Dialysis Ups Deaths in Undocumented Immigrants Emergency-Only Dialysis Ups Deaths in Undocumented Immigrants
Undocumented immigrants with end-stage renal disease who accessed hemodialysis on a emergency-only basis were more likely to die and to spend more time hospitalized, a study found.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 19, 2017 Category: Consumer Health News Tags: Nephrology News Source Type: news

Uric Acid, Protein and Mortality in Hemodialysis Patients Uric Acid, Protein and Mortality in Hemodialysis Patients
What do we currently know about the association between uric acid concentrations and mortality in hemodialysis patients -- and how does protein intake fit into the equation?Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 19, 2017 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

Body Weight Changes and Mortality in Hemodialysis Patients Body Weight Changes and Mortality in Hemodialysis Patients
A new study examines the association of post-dialysis weight changes with all-cause mortality in hemodialysis patients.Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 12, 2017 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

NxStage touts reduced technique failure in Nx2me home hemodialysis study
NxStage Medical (NSDQ:NXTM) today released the results from a study of its Nx2me connected health remote patient management system for patients using home hemodialysis, touting a 29% reduction in technique failure of conversion to in-center hemodialysis by 29%. Results from the study were published in the journal Hemodialysis International, the Lawrence, Mass.-based company said. Data came from a total 606 Nx2me users including both patients on home hemodialysis with the NxStage System One and new home hemodialysis patients, NxStage said. Technique failure was reduced by 34% For patients who began to use the Nx2m...
Source: Mass Device - December 8, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Patient Monitoring NxStage Medical Inc. Source Type: news

Nanotechnology Poised to Transform Fistula Creation Nanotechnology Poised to Transform Fistula Creation
A new approach could allow interventionalists to create an arteriovenous fistula for hemodialysis access in an office-based procedure, report investigators.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 9, 2017 Category: Consumer Health News Tags: Nephrology News Source Type: news

Baxter touts minimal albumin loss in Theranova HDx therapy studies
Baxter (NYSE:BAX) today released data from a study of expanded hemodialysis using its Theranova dialyzer, touting that the device was shown to successfully remove mid-sized uremic toxins from the body with minimal albumin loss. Results from the study were presented at the American Society of Nephrology’s annual Kidney Week Congress, the company said. The Deerfield, Ill.-based company’s Theranova dialyzer is designed to extend the range of molecules that it filters from the blood, which the company claims “more closely mimics the natural kidney.” The expanded hemodialysis therapy works on standa...
Source: Mass Device - November 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Baxter Source Type: news

What Causes White Nails?
Discussion The nail matrix covers the area of the nail plate, and extends proximally in a crescent moon shape with the edges of the crescent extending proximally and inferiorly toward the underlying bone. The nail matrix is a multilayered epithelium that physiologically produces keratinization and gives rise to the nail plate. The distal matrix forms the lower 2/3s of the nail plate and the proximal matrix forms the upper 1/3 of the nail plate. the thickness of the nail plate is proportion to the matrix’s thickness. The nail plate’s free edge contour follows the shape of the nail’s lunula. Melanocytes occ...
Source: PediatricEducation.org - November 6, 2017 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news

UC researchers examine racial and gender disparities in dialysis patients
(University of Cincinnati Academic Health Center) UC researchers are examining racial and gender disparities in dialysis patients as well as the impact of poor functional status and pre-dialysis hospitalizations on elderly dialysis patients. The research team presented four separate studies, all based on data from the United States Renal Data System. Three of the four studies accounted for elderly patient pre-dialysis health status, while the fourth examined racial and gender disparities and the type of vascular access in hemodialysis patients. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - November 3, 2017 Category: International Medicine & Public Health Source Type: news

MassDevice.com +5 | The top 5 medtech stories for October 20, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. This surgical glue seals wounds in 60 seconds A potentially life-saving surgical glue that is highly elastic and adhesive can quickly seal wounds in seconds without the need for common staples or sutures. The surgical glue, cal...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: MassDevice Tags: Blog News Well Plus 5 Source Type: news

FTC seeks more information on Fresenius ’ $2B NxStage buy
Fresenius Medical Care (NYSE:FMS; ETR:FRE) and NxStage Medical (NSDQ:NXTM) have received a request from the US Federal Trade Commission asking for more information on Fresenius’ $2 billion acquisition of NxStage, according to an SEC filing. The companies originally announced the acquisition in August, with Fresenius looking to pay $30 per share for Lawrence, Mass.-based home hemodialysis developer NxStage. The request from the FTC will extend the waiting period imposed by the HSR act until 30 days after the companies have complied with the request, though that period can be terminated earlier by the FTC, Nx...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Fresenius NxStage Medical Inc. Source Type: news

The influence of spirituality and religiousness on suicide risk and mental health of patients undergoing hemodialysis - Loureiro ACT, de Rezende Coelho MC, Coutinho FB, Borges LH, Lucchetti G.
BACKGROUND: Despite the large amount of literature assessing how spiritual and religious beliefs have an impact on mental health and suicide risk in various groups of patients, few studies have investigated patients with chronic kidney disease (CKD). The p... (Source: SafetyLit)
Source: SafetyLit - October 5, 2017 Category: International Medicine & Public Health Tags: Risk Factor Prevalence, Injury Occurrence Source Type: news

Baxter launches 2 studies of HDx hemodialysis using Theranova dialyzer
Baxter (NYSE:BAX) said today it launched 2 new clinical trials exploring expanded HDx hemodialysis therapy using its Theranova dialyzer. The Deerfield, Ill.-based company’s HDx therapy uses a Theranova dialyzer designed to extend the range of molecules that it filters from the blood, claiming it “more closely mimics the natural kidney.” The therapy works on standard equipment and does not require the generation of replacement fluid, Baxter said. “Millions of patients with chronic kidney disease rely on renal innovations every day, many of whom have ESRD and require HD therapy to stay alive. HDx...
Source: Mass Device - October 3, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Baxter Source Type: news

Humacyte lands $14m to expand uses for human acellular vessel
Humacyte said today that it landed a $14.1 million award from the California Institute for Regenerative Medicine to support a clinical trial comparing its human acellular vessel, Humacyl, to arteriovenous fistulas – the traditional way to create vascular access in patients who need hemodialysis. The Research Triangle Park, N.C.-based company said it plans to evaluate Humacyl as a conduit for hemodialysis in a group of patients with end-stage renal disease who need renal replacement therapy. “This significant and incremental investment from CIRM further validates the potential of our bioengineered human acellula...
Source: Mass Device - September 29, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Funding Roundup Regenerative Medicine Vascular Humacyte Inc. Source Type: news

TVA Medical wins CE Mark for EverlinQ 4 endoAVF
TVA Medical said today it won CE Mark approval in the European Union for its EverlinQ 4 endoAVF system designed for creating hemodialysis access using an endovascular approach. The Austin, Texas-based company said the system consists of 2 magnetic catheters which are inserted into an artery and vein in the arm and use a small amount of radiofrequency energy to connect both to create a fistula. The catheters are then removed and the brachial vain is coil-embolized for future dialysis. “The new system with smaller profile catheters and radiopaque visual indicators was extremely easy to use. This new approach streamline...
Source: Mass Device - September 27, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Vascular TVA Medical Source Type: news

7 medtech stories we missed this week: Sept. 15, 2017
[Image from unsplash.com]From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to lead its Restrata wound matrix study. The study will surgery the clinical outcomes of Restrata treatments for diabetic foot ulcers and test for effectiveness and safety. Restrata is a fully synthetic wound matrix that is FDA-cleared for ...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Business/Financial News Clinical Trials Dental Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Surgical Acera Surgical Contego Medical Fresenius MedTech OBP Medical Pinnacle Sciences Plusoptix Telos Source Type: news

Nutritional Considerations for Older Patients on Dialysis Nutritional Considerations for Older Patients on Dialysis
This report highlights the special considerations regarding the nutritional needs of aging hemodialysis patients.Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 15, 2017 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

AlloSource touts completion of bioengineered blood vessels for Humacyte trial
Tissue-provider AlloSource said this week it completed production of investigational bioengineered blood vessels designed for Humacyte‘s Phase III clinical trial exploring the use of the vessels to improve vascular access for hemodialysis patients with end-stage renal failure. The trail aims to compare the efficacy of the bioengineered human-tissue vessels to current synthetic vessels made from expanded polytetrafluoroethylene, Centennial, Colo.-based Allosource said. “AlloSource’s partnership with Humacyte supports our focus on regenerative medicine. Our organizations share a deep commitment to developin...
Source: Mass Device - September 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Research & Development Vascular allosource Humacyte Source Type: news

Predictors of acute kidney injury after paraquat intoxication - Weng CH, Chen HH, Hu CC, Huang WH, Hsu CW, Fu JF, Lin WR, Wang IK, Yen TH.
Paraquat intoxication is characterized by multi-organ failure, causing substantial mortality and morbidity. Many paraquat patients experience acute kidney injury (AKI), sometimes requiring hemodialysis. We observed 222 paraquat-intoxicated patients between... (Source: SafetyLit)
Source: SafetyLit - September 13, 2017 Category: International Medicine & Public Health Tags: Poisoning Source Type: news

High-Protein Meals and Lanthanum Carbonate in Hemodialysis High-Protein Meals and Lanthanum Carbonate in Hemodialysis
What benefits might an increased protein intake combined with lanthanum carbonate offer hemodialysis patients?Nephrology Dialysis Transplantation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 8, 2017 Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news

FDA Fast Tracks New Blood Filtration System
ExThera Medical, a developer of blood filtration systems and biotechnologies, has received Expedited Access Pathway (EAP) designation from FDA for its latest technology, the Seraph 100 blood filter. The EAP designation indicates that the use for the technology will be an adjunctive treatment for bacteremia, in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin-binding bacteria. ExThera applied for the EAP designation in June, and the company said FDA granted the designation within an accelerated timeframe. The company said its technology differs from other blood filter s...
Source: MDDI - August 31, 2017 Category: Medical Devices Tags: Business Source Type: news

Vascular access device maker Stent Tek closes Series A
Medical device firm Stent Tek said today it closed an undisclosed Series A financing round to support the development of its ePath AVF minimally invasive catheter technology. The ePath AVF device is designed for vascular access as an alternative to surgical fistulas for hemodialysis patients. Money in the round came from institutional investors Julz and Deepbridge Capital, the London-based company said. Stent Tek has previously received $1.6 million (GBP £1.2 million) in grant funding from the National Institute of Health Research, Innovate UK and the Royal Academy of Engineering Enterprise Hub. “I was thorough...
Source: Mass Device - August 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Stents Vascular stenttek Source Type: news

Exthera Medical wins FDA EAP designation for Seraph 100 blood filter
Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation. The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE and MRSE,” the company said. “We submitted our EAP application in early June. FDA responded by requesting additional information and clarifications, and Seraph was granted EAP designation with...
Source: Mass Device - August 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance ExThera Medical Source Type: news

Stent Tek Closes Series a Investment Round for its ePATH AVF Device, Aiming to Improve Vascular Access for Haemodialysis
LONDON, August 30, 2017 -- (Healthcare Sales & Marketing Network) -- 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 wit... Devices, Venture Capital Stent Tek, ePATH AVF, haemodialysis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 30, 2017 Category: Pharmaceuticals Source Type: news

FDA clears NxStage Medical's System One, allowing for solo home hemodialysis
NxStage Medical, a medical technology outfit focused on advancing renal care, has received clearance from the FDA for its System One, which allows for solo home hemodialysis, without a care partner, during waking hours.   (Source: mobihealthnews)
Source: mobihealthnews - August 28, 2017 Category: Information Technology Source Type: news

NxStage Medical wins expanded FDA nod for System One home hemodialysis system
NxStage Medical (NSDQ:NXTM) said today it won expanded FDA clearance for its System One home hemodialysis system, clearing it for use without a care partner during waking hours. The system won initial clearance in 2005 and added clearance for home nocturnal hemodialysis in 2014, the Lawrence, Mass.-based company said, but has always required a care partner be present during hemodialysis. “Patients have been asking for an FDA-cleared solo option for years,. Many patients have been turned away from home hemodialysis simply because they did not have a care partner.  The ability to train and treat solo provides a br...
Source: Mass Device - August 28, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance NxStage Medical Inc. Source Type: news

NxStage Medical Announces FDA Clearance for Solo Home Hemodialysis Using NxStage(R) System One(TM)
First clearance of its kind gives trained NxStage patients freedom to dialyze without a care partner LAWRENCE, Mass., Aug. 28, 2017 -- (Healthcare Sales & Marketing Network) -- NxStage Medical, Inc. (Nasdaq: NXTM), a leading medical technology company... Devices, FDA NxStage Medical, System One, home hemodialysis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 28, 2017 Category: Pharmaceuticals Source Type: news

Angola: Cuando Cubango General Hospital Unveiled
[ANGOP] Menongue -The new General Hospital of the southern Cuando Cubango province, fully equipped with high technological equipment to serve various services, especially hemodialysis, was inaugurated on Saturday by the Health Minister, Lu ís Gomes Sambo. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - August 21, 2017 Category: African Health Source Type: news