A Medical Device Daily
Allium Group (Caesarea, Israel), a maker of stents for the urinary, gastrointestinal, pulmonary and peripheral vascular tracts, said it has been awarded two CE marks for its biliary and ureteral stents.
The company said its thin-walled, large-caliber, self-expanding, fully covered metal stents “are unique because they can be left in the body for long periods without being changed and easily removed even after long implant periods.”
The stents are designed to treat malignant as well as benign obstructions and are engineered to prevent foreshortening during deployment, allowing what Allium described as “excellent accuracy in their placement and to prevent tissue in-growth.”
“The receipt of the CE marks paves the way to launch marketing in the European market this year,” said Dr. Baruch Levy, general manager and VP of technology.
Allium Group has developed a multi-patented technological platform to develop and produce site-specific stents designs tailored for each organ. These next-generation stents will enable physicians to offer more effective solutions to obstructive diseases and for enhancing the quality of life of patients.
Allium is a group of privately held companies established in 2001. It was founded and is led by Daniel Yachia, MD, a noted urologist and expert on urological stents. He is professor emeritus of urology on the faculty of medicine at the Technion-Israel Institute of Technology (Haifa).
The group’s several projects have received partial funding from the R&D investment program of Israel’s Ministry and Trade Industry’s Office of the Chief Scientist and Bi-National Cooperation Funds.
Allium has signed several European distribution agreements for marketing its stents and said it is looking to extend and expand its sales and operations worldwide.
1st use of ArterX sealant occurs in Germany
Tenaxis Medical (Mountain View, California), a developer of high-performance surgical sealants for the vascular and general surgical markets, reported that vascular surgeons at the Krankenhaus Friedrichstadt (Dresden, Germany) were the first to clinically use the company’s new vascular sealant, ArterX.
The investigational product was used on a 74-year-old man suffering from vascular insufficiency of the leg, requiring the implant of a synthetic vascular bypass graft. Tenaxis said such a procedure usually is accompanied by profuse bleeding at the suture lines and requires the physician to use manual pressure for up to 30 minutes to stop the bleeding. But in this case, the ArterX sealant, which has been designed to cure in 15 seconds, was applied over the top of the suture line and immediately stopped the bleeding through the needle holes created when the artificial graft was sutured in place and the artery-graft junction was exposed to full arterial pressure.
Dr. James Zimmerman, a vascular surgeon with Pacific Coast Cardiac & Vascular Surgeons (Redwood City, California), who attended the first surgery, said, “The procedure went flawlessly, the product was deployed over the top of the sutures, and on clamp release there was absolutely no bleeding.”
This was the first of up to 60 procedures that are anticipated to be conducted in Germany. Procedures also are under way in hospitals in Ulm and Cologne, Germany and the study is expected to be fully enrolled by the end of the summer.
The ArterX Vascular Sealant is based on a technology that uses a powerful crosslinking agent that covalently binds to proteins in both the sealant and human tissue.
“I am proud of the progress the team has achieved in developing a meaningful new generation of vascular sealants,” said Ronald Dieck, president and CEO of Tenaxis Medical. “This is the first step in a comprehensive clinical program to position this product for regulatory clearance and subsequent launch in Europe in early 2008, and in the U.S. in early 2009.”
UK expands payments for long-term care
UK Care Services Minister Ivan Lewis said late last month that thousands of people in England are likely to receive more help toward their care costs. The new National Framework for NHS Continuing Healthcare has been developed in close consultation with voluntary groups, professional bodies and patient/user groups and will make funding decisions on who is eligible for NHS continuing care fairer, faster and easier to understand, Lewis said.
He said the new framework, which is expected to cost up to £220 million in the first year of operation, will create “consistent access to fully funded care, with clear national policies for deciding eligibility.” The framework will be put into action by the National Health Service and local authorities beginning in October, Lewis said, “We understand that families have to make difficult and emotional decisions when someone has to go into residential care and this can be made worse by having to consider how this will be funded.”
At present, people with identical care needs can receive different decisions on whether they are eligible for fully funded continuing care, based purely on where they live. The new system will address these anomalies and will introduce one national system for everyone needing this type of care in England.
“To make the system fairer for everyone, we have produced new national guidance,” Lewis said. “It will not solve all the problems at once, but over time we expect there to be a real improvement that will lead to fair and consistent access to NHS funding across England, irrespective of location, diagnosis or personal circumstances.”
He added, “”This will make the system faster and more convenient for both patients and professionals. In particular, it will be of help to those who previously been excluded, such as younger adults with long term neurological conditions and older people with dementia or other mental health needs.”
Currently, nearly 31,000 people receive NHS continuing care, and about 70% of care home residents already have some or all of their personal care costs paid by the government.
The NHS already provides free registered nursing care for some 123,000 people.