A Medical Device Daily
Surgical instruments make Ortoviva (Stockholm, Sweden) said it has received CE-mark approval for its Distractor system, which it said "improves and simplifies" the insertion of disc prostheses in the spinal column.
The company said strong demand exists for "truly effective instrument solutions that can help surgeons to simply and accurately implant an artificial disc without complications."
It said the lack of proven instruments "has limited the sphere of both suitable patients and surgeons. As a result, many people have been forced to continue suffering from back problems, and some may even undergo spinal-fusion procedures that are entirely unnecessary."
Now, said CEO Stan Mikulowski, "we can provide a simple set of purpose-built instruments to facilitate deployment of disc prostheses and thus improve the probability for helping more patients return to a painless and normal life."
The instruments in the Ortoviva Distractor solution hold and separate the two vertebrae adjacent to a damaged disc. This ability to mechanically control position and orientation "enormously simplifies disc insertion," according to the company.
"We're already seeing growing interest from clinical specialists as well as disc implant manufacturers to start using the solution in this rapidly growing market," said Mikulowski. "Before the end of the year we will begin live patient clinical trial programs and we plan to submit an application for FDA approval in the U.S. early in 2009."
Ortoviva was founded in October 2006 by LinkMed (also Stockholm) and a group of experts in biomaterials, spinal surgery and medical devices.
LinkMed has built a portfolio of 12 companies, six in medical technology and six in drug development/biotechnology.
CE mark for hemostatic system
Starch Medical (SMI; San Jose, California) reported CE-mark approval of its PerClot Polysaccharide Hemostatic System (PHS) and the StarFoam Absorbable Polysaccharide Hemostat.
The company said introduction of PerClot PHS will begin this month in the European Union and other select international markets, while the StarFoam hemostat will launch during 2Q09.
PerClot PHS is an absorbable, surgical hemostat composed of Absorbable Modified Polymers (AMP), technology that incorporates plant-based polymer modification processes that yield biocompatible, polysaccharide particles. AMP particles contain no thrombin, collagen, or other human or animal components.
Starch Medical said a family of customized, single-use application instruments will enhance the delivery of AMP to the wound site for the control of capillary, venous and arterial bleeding in both open and minimally invasive surgical procedures.
The StarFoam hemostat, also developed with AMP technology, is produced in a hemostatic foam, or wafer, configuration. The company said application of StarFoam will feature a simple "press and release" technique.
SMI President David Lang said, "The clinical introduction of PerClot PHS and its proprietary, integrated AMP technology represents the next generation of polysaccharide hemostatic agents. The StarFoam product line will offer surgeons a choice of hemostatic formats for a range of surgical wounds."
He added, "Compared to current polysaccharide based hemostats, PerClot PHS and StarFoam demonstrate superior hydrophilic action and enhanced adhesive strength. These performance features, coupled with custom delivery systems, have been favorably received in a diverse range of surgical applications in Europe, Asia and Latin America."
Privately held SMI's patent-pending AMP technology platform includes powders, foams and films, and is focused on the worldwide, biomaterial, hemostasis and wound care markets.
Partec cites gains with CyFlow
Partec (Garlitz, Germany) is expanding its global leadership in specialized HIV monitoring and AIDS patient follow-up diagnostics for developing and emerging countries.
In 2008, 2.5 million patient tests have been performed with the portable, robust and affordable CyFlow system, already supporting more than 1 million people living with HIV/AIDS.
With the introduction of the Partec innovation, the company said the average cost of €160 per patient per year could be reduced to just €8.
CyFlow instruments are being successfully used in nearly all sub-Saharan African countries, and the technique is being applied in Asia, Latin America, Europe and the U.S.
This month, the thousandth CyFlow device will be placed since introduction at the XVI. International AIDS Conference in Barcelona in July 2002.
By precisely measuring the CD4 T-lymphocyte concentration from blood samples, the CyFlow delivers accurate information about the immune status level of HIV/AIDS patients. This test is required as a basis for antiretroviral therapy targeting in order to stabilize the immune status which is essential for survival.
Some 33 million people worldwide are living with HIV/AIDS, with more than 95% of them residing in developing countries, especially in Africa and Asia.
Hamilton heads UK medical education
The UK Department of Health reported the appointment of Dr. Patricia Hamilton as the new director of medical education for England. She will take up her post in the new year, replacing interim Director Professor David Sowden.
Hamilton is the president of the Royal College of Pediatrics and Child Health and consultant and senior lecturer in neonatal pediatrics at St. George's Hospital Medical School (London) and serves as a member of the Postgraduate Medical Education and Training Board.
In her new post, she will be responsible for the health department's Modernizing Medical Careers Program.
National Health Service Medical Director Professor Bruce Keogh said, "I am delighted that Patricia is joining the medical directorate at the Department of Health. Her experience in pediatric medicine and postgraduate medical training will prove invaluable in developing medical education for England."