A Medical Device Daily
The Sorin Group (Milan, Italy) reported receiving the Japanese Pharmaceutical and Medical Devices Agency's (PMDA) approval to market its St ckert S5 Heart-Lung Machine in that country.
With more than 30 years of experience in the cardiopulmonary field, Sorin terms itself "the undisputed leader in the manufacturing and marketing of heart-lung machines," with a share of more than 60% of the installed base of machines worldwide.
It said it "works closely ... with perfusionists across the globe in order to ensure that the most advanced features and technologies are adopted and better patient outcome is achieved."
Sorin said its 7,000th perfusion system — an S5 (for St ckert 5th generation) heart-lung machine — was shipped recently to Brisbane, Australia. A heart-lung machine provides blood circulation and oxygenation to organs and brain while the patient's heart and lungs are temporarily stopped during open-heart cardiac surgery procedures.
Launched in Europe, the U.S. and other international markets between the end of 2005 and 2006, Sorin said the St ckert S5 is the fifth generation of heart-lung machines and successor to the company's SIII perfusion system.
The company said S5 technology "sets new standards for safety, functionality and quality and will help hospitals achieve better patient outcome[s]."
It said that the smaller footprint of the S5 allows closer positioning of the unit to the patient, reducing line lengths and the possibility of hemodilution. Also, acoustically differentiated alarms and information displayed on the touch-screens describe the status of all monitoring functions of the extracorporeal circuit.
Sorin said that the S5 "has no boot-up time: this means that the pumps are operable three seconds after turning the system on, which is extremely important in emergency situations." The S5 does not use PC-based technology to control the system — all modules are directly programmed to perform a perfusion specific function and are interchangeable.
Beijing institute adds 17 Genome Analyzers
Illumina (San Diego) said Beijing Genomics Institute (BGI) purchased 11 Genome Analyzers, increasing the Chinese organization's total number of the Illumina sequencing systems to 17.
BGI is the fourth genome center to expand its Genome Analyzer install base to double digits, the company said, and that as a result of recent enhancements to the Genome Analyzer, BGI researchers "will have the capacity to sequence more than two human genomes to 25x coverage per week."
It said this increase in throughput will expand BGI's capacity for sequencing services to local genetic research labs, as well as broaden the range and pace of large-scale sequencing projects undertaken by the organization.
Xiuqing Zhang, director of the sequencing division at Beijing Genomics Institute, said, that the institute "BGI is focused on accelerating the rate of scientific discovery, and expanding our understanding of genetic variation and diversity across human genomes. We have worked closely with Illumina to determine ways to dramatically increase our sequencing capacity in order to efficiently and quickly complete several new large sequencing projects." He judged Illumina "the most suitable high-throughput sequencing platform for accurate de novo genome sequencing."
"BGI's decision to acquire 11 additional Genome Analyzers is further validation that our sequencing platform is delivering leading performance, and becoming the sequencing platform of choice," said Christian Henry, acting general manager of Illumina's Sequencing business. "With its ... rate of daily output, ease of use and proven paired-end sequencing capability, the Genome Analyzer will continue to provide the scalable solution researchers need to complete projects that were not possible one year ago."
Contaminated heparin spreads to more countries
U.S. health officials reported this week that contaminated heparin products have now been found in nearly a dozen countries.
Officials said contaminated lots of the blood thinner have been traced to 12 different Chinese companies that were involved in heparin manufacture. It is believes a man-made chemical called oversulfated condroitin sulfate (OSCS) may be responsible for dozens of deaths and hundreds of adverse reactions in the U.S. between last November and February.
The heparin was marketed by Baxter International (Deerfield, Illinois).
"We do not know where the contamination occurred but we do know ... of at least 12 Chinese firms that are in the supply chain for contaminated heparin," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
The FDA issued a warning letter on Monday to Changzhou SPL, which supplies heparin to Baxter International, stating that its manufacturing equipment was "unsuitable for its intended use" and that the company did not adequately scrutinize its own suppliers.
Changzhoi and its parent company, Scientific Protein Laboratories (SPL; Waunakee, Wisconsin), expressed "regret" at the FDA warning letter. "We do not believe that the warning letter reflects Changzhou SPL's actual state of compliance with current good manufacturing practices in the heparin Active Pharmaceutical Ingredient (API) industry, or the positive findings in prior third-party audits of the facility," SPL said in a statement.
The FDA said there have been "no reports of adverse events" in the other countries that turned up contaminated heparin, including Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands and New Zealand.
Not all contaminated Heparin emerged from Baxter International, Woodcock said.
pSivida to reincorporate in U.S.
pSivida (Perth, Australia) said that it proposes to reincorporate in the U.S. The reincorporation, which is subject to Australian Federal Court and shareholder approval, will occur in mid-2008.
The company said the reincorporation is designed to make it a "more attractive" investment for shareholders by increasing the potential scope and depth of the company's shareholder base and liquidity while maintaining strong ties with the Australian investor base.