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 quarter performa...
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 Streamline’s benefits a...
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 the Dialog...
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

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 authorization a...
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 million stra...
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 laparscopic technology ...
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 system ...
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