A Medical Device Daily
Lantheus Medical Imaging (North Billerica, Massachusetts) said it has finalized an arrangement with the Australian Nuclear Science and Technology Organization (ANSTO; Lucas Heights, Australia) to receive molybdenum-99 (Mo-99) produced from low-enriched uranium (LEU) targets in ANSTO's new OPAL reactor.
This supply arrangement positions Lantheus to be the first company to supply technetium-99m (Tc-99m) derived from LEU to the U.S. market and demonstrates, the company said, its commitment to ensuring reliable supply and global access to Tc-99m, the medical isotope used in about 80%of all nuclear medicine procedures.
Lantheus will soon receive a supply of Mo-99 at regular intervals from ANSTO for use in its TechneLite generator line, which is currently distributed to the U.S. and Canadian markets.
ANSTO has secured the necessary regulatory approval from the Therapeutic Goods Administration (TGA) in Australia to use the LEU Mo-99 in a Tc-99m generator. The LEU-derived Mo-99 from ANSTO has been tested and validated by Lantheus for use in its TechneLite generator line to ensure its consistency and reliability.
Lantheus said this arrangement supports its supply chain diversification strategy and marks another step to address the limited and fragile global Mo-99 supply chain, as evidenced by the current NRU reactor shutdown in Canada.
ANSTO is working closely with nuclear safety and health regulators, both domestically and overseas, to expedite all necessary approvals to allow long-term production and export of medical isotopes.
Lantheus, together with ANSTO, is working closely with the FDA and Health Canada to achieve the necessary LEU Mo-99 approvals for the U.S. and Canadian markets.
"This supply arrangement marks a significant step in the advancement of medical imaging – for the first time in industry history, we will be able to offer the nuclear medicine community in North America a LEU-derived Mo-99 through our TechneLite generator line," said Lantheus President/CEO Don Kiepert. "We have been actively exploring new options for securing Mo-99 produced using LEU, and in ANSTO we have found an ideal partner with which to achieve that strategic goal. This arrangement will help ensure patients receive the benefits of diagnostic imaging with Tc-99m and at the same time support U.S. non-proliferation efforts to move from commercial use of HEU to LEU."
Study: Telehealth can reduce cardio risk
The use of phone and Internet between patients and healthcare providers is an effective way to reduce risk factors for coronary heart disease and the risk of further events after a heart attack, according to new research published in the June issue of the European Journal of Cardiovascular Prevention & Rehabilitation.
The study's senior investigator, Ben Freedman, MD, of the department of cardiology at Concord Repatriation General Hospital (Sydney, Australia), says that the provision of "telehealth" models could help increase the uptake of coronary prevention activities by those without access to cardiac rehabilitation, and "narrow the gap between evidence and practice"
That evidence has already shown that formal cardiac rehabilitation programs consistently reduce the risk of further events, improve personal risk factor profiles, encourage compliance with drug therapy, and enhance quality of life through exercise and education. However, according to Freedman, it also is known that only one-third of eligible patients participate in cardiac rehabilitation programs in Europe, the U.S. and Australia.
This new study, a systematic review of trials applying new communication technologies in cardiac prevention, suggests that telehealth can indeed provide an "innovative model" by which access is increased and the "diverse nature of people and communities accommodated."
The review analyzed all published randomized trials evaluating a telephone or Internet-based intervention whose end-points were a measure of mortality, changes in levels of multiple risk factors for heart disease, or quality of life.
The study's lead author, Lis Neubeck, also of Concord Repatriation General Hospital, said, "We aimed to determine if, in a world increasingly dominated by electronic technology, interventions for preventing recurrent coronary disease could be delivered in innovative ways to enable more people to access effective secondary prevention. Our analysis, which involved more than 3,000 patients across 11 studies, suggests that the electronic age is indeed providing effective alternatives for the delivery of preventive health change."
Injunction issued in KCI case
Kinetic Concepts (KCI; San Antonio) said that the Federal Court of Australia, Victoria District Registry, has issued a temporary injunction prohibiting Smith & Nephew (S&N; London) from selling foam dressing kits for negative pressure wound therapy in Australia until the court can rule on the patent infringement action brought against Smith & Nephew by KCI.
S&N is allowed to provide trial samples in limited circumstances during the interim.
KCI said a UK court already has issued an injunction against Smith & Nephew, and courts in the U.S. and Germany plan to consider the granting of an injunction. A trial date on the infringement and validity of the patent is expected to be set in the Australian courts for 2010.
Stephen Seidel, KCI executive vice president, chief administrative officer and general counsel, said, "This ruling helps confirm the importance of patents in a competitive and innovative environment. Protecting patents represents a fundamental step due any innovative company, and it encourages new and more effective alternatives for patients."