A Medical Device Daily

Fresenius Medical Care (Bad Homburg, Germany) reported that it is offering, for the first time, online hemodiafiltration (HDF) as standard treatment as part of its new 5008 Therapy System.

The company said that until now, increased costs made online-HDF viable for only a few patients. With the 5008, it said operating costs have been “significantly reduced” through simpler user interfaces, lower maintenance effort and as much as a 30% reduction in electricity and water usage.

Online-hemodiafiltration combines two different methods of removal of toxins: diffusion-based hemodialysis and hemofiltration whereby blood is filtered through a membrane. Fresenius said HDF is particularly efficient when filtering toxins and removing water from the patient's blood.

The 5008 Therapy System automatically replaces the fluid removed with an appropriate quantity of ultrapure electrolyte solution that is prepared by the dialysis machine online, eliminating the need for additional infusion solutions in bags.

Fresenius said that the mortality rate among patients with kidney disease is “significantly lower” with hemodiafiltration than with conventional hemodialysis. A new study conducted by specialists at the University Hospital (Lapeyronie, France) and led by nephrology professor Bernard Canaud showed that kidney patients treated with high-efficiency hemodiafiltration therapy had a 35% better chance of survival than those who received traditional hemodialysis.

The three-year Dialysis Outcomes and Practice Patterns Study (DOPPS) from five European countries involved 2,165 patients who received treatment an average of three times per week.

A retrospective study published last year using existing data had already provided the first indications of the positive effects of HDF, the company said.

Specialists attribute the improved survival rates with the HDF therapy to a more efficient removal of harmful substances from the blood, fewer side effects and a lower overall risk of cardiovascular illness. Cardiovascular complications remain the most common cause of mortality among dialysis patients.

Dr. Emanuele Gatti, Fresenius Medical Care management board member responsible for Europe, Latin America, the Middle East and Africa, said, “The positive results of the new study support our efforts to provide innovative treatment methods such as hemodiafiltration to allow patients with chronic kidney failure to look confidently towards the future. We expect the demand for online-HDF to continue growing.”

Fresenius Medical Care is the world's largest integrated provider of products and services for those undergoing dialysis, with a network of about 2,000 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa providing treatment to some 157,000 patients. It is also the leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.

Clinical trial plan okayed

CardioTech International (Wilmington, Massachusetts) said it has received written acknowledgement from its Notified Body in Europe that its clinical trial plan for CardioPass synthetic coronary artery bypass (SynCAB) has been accepted.

Following the 10-patient trial, the analyzed data will be submitted by CardioTech to the Notified Body in support of the company's CE mark application.

The trial protocol allows surgeons to intraoperatively decide to use CardioPass synthetic coronary artery bypass instead of autologous vessels. Patients will be followed for 90 days and assessed for graft patency and quality of life measures.

Michael Szycher, PhD, chairman and CEO, said, “This planned trial brings us a step closer to fulfilling the unmet need of providing patients with a suitable alternative to an autologous vessel.”

CardioTech estimates that of the 600,000 coronary bypass operations performed worldwide, about 15% of veins are found to be suboptimal.

Michael Adams, vice president of regulatory affairs and business development, said, “Potential clinical trial sites have been identified and we will be working closely with them as we prepare to commence the study.”

PD/AD gene expression assay reported

DiaGenic (Oslo, Norway) said it presented a poster on discriminatory assays for Parkinson's and Alzheimer's diseases during the European Regional Meeting of the International Psychogeriatric Association in Lisbon, Portugal.

The study employed a peripheral blood-based assay with a specific Alzheimer's gene expression signature developed using DiaGenic's propietary method.

Researchers found that 19 out of 20 Parkinson's-diagnosed patients could be successfully discriminated from Alzheimer's sufferers. A specific gene expression signature for Parkinson's also was identified.

The study is part of a larger follow-on study validating DiaGenic's Alzheimer's gene expression assay on an ABI microarray platform, the results of which will be presented at the ICAD meeting in Madrid, Spain, in July.

“These findings showing that our blood-based gene expression assay approach can also be applied to Parkinson disease is extremely encouraging,” said Anders Lonneborg, CEO of DiaGenic. “Alzheimer's and Parkinson's have different underlying pathologies, but overlapping clinical profiles, as many PD patients will also develop dementia. Our goal is to develop simple blood-based tests that will enable physicians to discriminate between patients at an early stage, since an increasing number of studies show that early therapeutic intervention can make a significant difference in improving quality of life.”

Piper Jaffray expands in UK

Piper Jaffray 's (Minneapolis) United Kingdom subsidiary, Piper Jaffray Ltd. (London), reported the expansion of its healthcare business in the UK with the additional hires of two investment bankers and two research analysts.

Joining Piper Jaffray are Neil Mackison and Rupert Winckler in investment banking. Mackison is a managing director and previously was the head of European Health Care Investment Banking at ING. He has more than 18 years of experience in corporate finance, focusing on the UK healthcare sector. Winckler is an associate investment banker and also joins from ING, where he was part of the healthcare investment banking group.

Sally Bennett and Richard Parkes join the firm as senior research analysts. Bennett was a director at ING Wholesale Bank, where she was part of the biotechnology research team. Parkes previously was a vice president at ING Wholesale Bank, where he was part of the biotechnology research team.