BB&TEuropean Editor and Staff Reports
PARIS — The European Commission (EC) reported in June that it will exempt MRI from its upcoming directive regulating exposure to electromagnetic fields (EMF). The medical community and MRI makers across Europe let out a collective sigh of relief and a slew of press releases welcoming this announcement. The original draft directive would have effectively shut down high-field MRI research and curtailed routine medical scans.
Three years ago the EC acknowledged the heavy-handed impact on medical MRI was an unintended effect of new rules aiming to protect workers from the uncontrolled exposure to EMF from welding tools, overhead power lines, or even banks of computer terminals in confined office spaces.
The issue might have been settled with a simple gum eraser, but this is Brussels and the European Union (EU). An adminstrative oversight unintentionally setting limits on medical EMF became a bureaucratic imbroglio.
“No one would believe something so stupid that could eliminate the use of MRI for clinical procedures would be possible, but that is exactly the risk,“ said Gabriel Krestin, MD, PhD, the European Society of Radiology (ESR) VP who is the lead spokesman for the Alliance for MRI.
The Alliance was established in March 2007 to maintain a concerted lobbying effort in Brussels for ESR. The Alliance won a postponement of the implementation deadline from April 2008 to April 2012 and created an opportunity to continue influencing the EC to revise the text it will send to the European Parliament.
Adoption of the original EMF Directive would have set limits on gradient fields for MRI that would prohibit interventional procedures, forbid nurses from remaining with patients during a scanning procedure, and have an unknown impact on the design of new scanners.
“The Directive is a blunt instrument,“ said Stephen Keevil from King's College London, who also is a spokesman for the MRI Alliance. “It sets exposure limits that either relate to harmless effects, or are well below the threshold at which any effects occur.“
Yet once the question of EMF in the medical setting was opened, it drew unwanted attention to the huge magnets and radio frequency coils used in radiology clinics. The danger of flying metal objects around MRI scanners is well-understood, but the new level of scrutiny highlighted concerns that prolonged EMF exposure may have an adverse effect on the central nervous system called Peripheral Nerve Syndrome that creates a short-term pins-and-needles sensation.
“PNS is the biggest issue, and the threshold where this effect begins is well-established,“ Keevil said.
Manufacturers test gradient limits for new MRI against the International Electrotechnical Commission (IEC) standards, he said, which in turn is harmonized with the EU's Medical Device Directive that allows the granting of a CE mark. If the original proposal passed, “we will have a curious situation where it is legal to buy a scanner but it is illegal to use it,“ he said.
“We need to take this Directive seriously because once it has been adopted we will be obliged to implement its provisions,“ Keevil said. “You can not go to a hospital administrator saying what you do is slightly illegal but that you won't get caught.“
The first draft EMF Directive set a threshold for MRI operation that is three times below the established IEC standard for MRI, he explained.
“We do agree there is a need for safe working practices, which exist in some countries and can be harmonized across the European Union,“ Keevil said. “We support guidelines, but based on the evidence there is not a need to set precautionary limits.“
Earlier this year the German Ministry of Employment and Social Affairs objected to a deal between the Alliance and the EC to exempt MRI from the EMF limits in exchange for reinforcing a set of work safety guidelines. The German position was that hard limits on EMFs were needed to protect workers and patients rather than the soft influence of guidelines. Poland and Sweden took up the German position as well.
In its announcement last month, the EC decided on the guideline approach saying MRI will be exempt from the exposure limit values of the directive but workers using MRI will be protected through existing regulations to ensure its safe use.
“We did win a battle, but we did not win the war, we only succeeded in postponing the problem,“ Krestin said.
Court finalizes sale of half of Shamir assets to Essilor
Shamir Optical Industry (Kibbutz Shamir, Israel) reported that on June 13, the District Court of Nazareth gave its final approval for Essilor (Charenton-le-Pont, France) to complete its acquisition of 50% of Shamir, following the approval of the transaction by Shamir's shareholders.
Last October, Essilor agreed to acquire 50% of Shamir through a series of transactions. As a result, Kibbutz Shamir and Essilor will each own half of Shamir Optical, a company that provides products and technology to the opthalmic lens industry.
Essilor will be buying 37% of the company's shares that are publicly held, and the remaining 13% from Kibbutz Shamir, which currently holds 63% of the company's stock and will retain 50%.
Varian receives Shonin approval for TrueBeam
Varian Medical Systems (Tokyo), a maker of medical technology for treating cancer with radiotherapy, said it has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the TrueBeam system for image-guided radiotherapy and radiosurgery in Japan. Designed for the treatment of lung, breast, prostate, head and neck, and other types of cancer, Varian's TrueBeam system was engineered from the ground up to treat tumors with great speed and accuracy — including tumors that move during treatment as the patient breathes in and out.
TrueBeam features a multitude of technical innovations that dynamically synchronize imaging, patient positioning, motion management, and treatment delivery. Applicable for all forms of advanced external-beam radiotherapy including image-guided radiotherapy and radiosurgery, intensity-modulated radiotherapy, stereotactic body radiotherapy and RapidArc radiotherapy, TrueBeam can deliver treatments with a dose delivery rate that is roughly twice the maximum output of conventional systems. This makes it possible to offer shorter treatment times for patients, potentially enabling clinics to treat more patients each day and to improve precision by leaving less time for tumor motion during dose delivery.
Varian also offers the Trilogy and Clinac systems for image-guided radiotherapy, which have been approved for sale in Japan since 1995.
“TrueBeam is Varian's most advanced cancer treatment system. It combines high dose delivery rates, image-guidance, RapidArc, and motion management capabilities, making it particularly well-suited for treating cancer of the lung and liver, two of the five most prevalent forms of cancer in Japan,“ said Makoto Yamada, sales manager for Varian in Japan.
Theramed to launch new Glenveigh products
Theramed (Mississauga, Ontario) said it will launch ebb and jetty at the 67th Clinical Meeting of the Society of Obstetricians and Gynecologists of Canada. The two newly developed medical devices are to be used to advance the practice of obstetrics, from Glenveigh International. Both medical device products have been approved for sale by Health Canada, and Theramed will begin distributing these products on June 17. “We are very excited to partner with Glenveigh Medical in advancing obstetrics for healthy moms and babies in Canada,“ said Bill Baugh, Theramed's CEO.
ebb is a complete tamponade solution for postpartum hemorrhage. The ebb balloon is made of a malleable yet extremely strong material, allowing ebb to expand and conform to any uterine shape. ebb also features a vaginal balloon to control vaginal bleeding and act as an anchor to support the uterine balloon. External ports allow independent control of inflation, deflation, irrigation, and drainage.
The jetty Vaginal Repair Balloon is indicated for use during episiotomy and vaginal laceration repair to temporarily prevent the postpartum discharge of fluids from the vagina in order to assist with the repair procedure. jetty provides clarity and cleanliness for a timely, effective repair, and it eliminates the need for vaginal packing with gauze or sponges.
Theramed obtained the exclusive distribution rights in Canada for the two products back in April.
Medical Care Technologies expands Chinese operations
Medical Care Technologies (MCT; Beijing), a children's healthcare service provider, reported its plans to expand its pediatric healthcare operations to other provinces in China.
With the official license to operate its first pediatric healthcare center in the City of Dongguan firmly approved in principal, the door is opened for MCT to further expand and develop additional pediatric health and wellness centers in new provinces throughout China. Management is in negotiations with officials to expand in Heilongjiang, Beijing, and Shanghai.
The company said it is now developing up to five more healthcare centers to be operational within the next two years. The facilities will range in size from 3,000 to 8,000 square feet and cater to young children from three years of age to their teenage years. The health centers will offer a full range of inpatient services to both expatriates' families and the Chinese communities. Management's development strategy will utilize an integrated concept of primary facilities and satellite clinics in each geographical location, thereby offering a high quality of healthcare services to the large local Chinese market. Assuming that the final Chinese government approvals and plans for financing the health centers are completed soon, the facilities will be constructed and opened in phases starting in 2012.
UC Davis, BGI form genomics programs
The University of California, Davis, and the Beijing Genomics Institute (BGI, Beijing) agreed last month to form a partnership to conduct large-scale genome sequencing and functional genomics programs, focusing initially on the areas of food security; human and animal health and wellness; and biodiversity and environmental health.
UC Davis Chancellor Linda P.B. Katehi and BGI Director Jian Wang signed a formal agreement to establish the BGI@UC Davis Partnership during a meeting in Shenzhen, one of China's Special Economic Zones.
“This partnership will bring together the unique strengths of two world-class institutions,“ Katehi said. “BGI's resources in genome sequencing and bioinformatics, combined with UC Davis' expertise in biology, medicine, agriculture and the environment, will bring advantages to both partners as we take on crucial issues in food, health and sustainability.“
“Genomics is laying the foundation for the future research of biology, and this cooperation plays a significant role in the development of science and education between the two sides,“ Wang said. “It's necessary to build a new creative model for multiple-skilled talents in genomics for the future. In the past several years, BGI has invented a new model to train excellent professionals that is efficient both at up-to-date scientific knowledge and practical skills in life sciences.“
As envisioned in the formal agreement, UC Davis faculty and students will gain access to the capabilities and expertise of one of the world's premier genomics and bioinformatics companies, while BGI researchers will be able to access the university's diverse resources and expertise in education and research, especially in biology, human and veterinary medicine, agriculture and the environment.
In the coming months, representatives of BGI and UC Davis will work out a detailed agreement for the partnership that in the future will bring to UC Davis DNA sequencing instruments and bioinformatics specialists – scientists who apply statistics and computer science to molecular biology.
UC Davis is internationally recognized as a leader in research in agriculture, food security, food science and technology, and biological sciences. The campus includes a medical school and teaching hospital ranked in the top 50 in the U.S., one of the nation's foremost veterinary medical schools, a National Cancer Institute-designated cancer center and a National Institutes of Health-funded Clinical and Translational Science Center.
Chinese, Indian hearing aid markets up for grabs
According to a new report by iData Research (Vancouver, British Columbia), the Chinese and Indian markets for hearing devices, including retail and wholesale sales, is valued at more than $1 billion and will almost double-in-value by 2017. Growth in these countries will be driven by improved distribution by major foreign retail-chains such as Amplifon (Milan, Italy), in a traditionally fragmented and underdeveloped industry. Hearing aid promotion and education from brand-name manufacturers such as Siemens is also driving adoption among the more than 400 million hearing aid candidates in these countries.
The report states that, within India, major international hearing aid brands such as Widex (Vaerloese, Denmark) and Beltone (Glenview, Illinois) have opened retail locations, while regionally, retail-chain Amplifon merged with National Hearing Care to gain market share. As the purchasing power of retail-chains grow in both India and China, prices are expected to decrease, driving unit sales to double-in-volume by 2017. Siemens (Erlangen, Germany) GN ReSound (Bloomington, Minnesota), Sonova (Stafa, Switzerland), Starkey (Minneapolis) and Widex are the top manufacturers positioned to benefit from this growth.
Gore receives Canadian approval for Seamguard
W. L. Gore & Associates (Flagstaff, Arizona) reported in June that it has received approval from Health Canada for the Gore Seeamguard Bioabsorbable Staple Line Reinforcement. The device is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. With more than 15 years of bioabsorbable material technology research and clinical use supporting it, the Seamguard has a proven record of safety. Worldwide, more than 500,000 successful implants have been completed and more than 40 clinical papers have documented its successful use in bariatric, colorectal and thoracic procedures, the company noted.
The company said that Seamguard is 100% bioabsorbable with a synthetic tissue scaffold. It is engineered for consistent thinness to allow proper staple formation. While providing added strength to the staple line during the critical healing process, this reinforcement is gradually and predictably absorbed, usually within six months. The risk of a prolonged inflammatory response is eliminated.
Constructed from polyglycolic acid-trimethylene carbonate, a medically proven biocompatible copolymer, Seamguard is composed of a matrix of open, highly interconnected pores facilitating cell infiltration, tissue generation, growth and healing.
Herzig offering TeraScience's LipFlow
TearScience (Morrisville, North Carolina) reported last month that the Herzig Eye Institute (Toronto, Ontario), a provider of laser vision correction and advanced cataract and refractive surgery, is the first eye care center in North America to introduce the LipiFlow evaporative dry eye disease treatment system, which has received a medical device license from Health Canada.
Evaporative dry eye is caused by a deficiency in the lipid layer of the eye's natural tear film, resulting from blockages in the lipid-producing meibomian glands located in the eyelids, called meibomian gland dysfunction. A lipid deficiency can lead to evaporation of tears at a faster rate than normal, which can leave eyes feeling dry, irritated, tired and red.
Of the more than 100 million dry eye sufferers worldwide, approximately 65% have evaporative dry eye. TearScience's LipiFlow Thermal Pulsation System is a significant technological shift in treating meibomian gland dysfunction and evaporative dry eye, allowing eyelid gland blockages to be treated during a non-invasive procedure at an eye care office. Opening the blocked eyelid glands allows the glands to resume the natural production of lipids needed for a healthy tear film.
TearScience's technology platform is comprised of the LipiView Ocular Surface Interferometer and the LipiFlow Thermal Pulsation System. LipiView allows physicians to visualize the tear film of patients with dry eye disease. LipiFlow applies a precise combination of heat and pressure to a patient's eyelids during a 12-minute in-office treatment, which is designed to alleviate meibomian gland blockages.