OXFORD, UK — The accent was on electronic health records (EHRs) at Europe's annual Connectathon for health information systems, held in mid-April at St. Catherine's College.
For the first time in the eight-year history of the event, the number of tests for interoperability between vendor products and hospital IT infrastructure challenged the traditional dominance of testing for new radiology and picture archiving and communications systems.
This shift in emphasis among the 83 vendors participating in the event can be explained in large part by the growing importance of EHR programs emerging across Europe, according to Eric Poiseau, technical manager for Integrating the Healthcare Enterprise in Europe (IHE-Europe; Brussels), Connectathon organizer.
This year's European event also saw the first tests for reliability of data from point-of-care (POC) devices using specifications developed through the open development methods of IHE. The newly developed POC requirements are part of the larger IHE Laboratory domain pioneered by IHE teams in Europe and Japan and responds to what one Connectathon executive said is "a tremendous frustration building among people who are screaming for lab reports, people who want them right now on their office computer.
Laboratory Point of Care Testing (LPOCT) specifications developed by IHE-Europe cover the workflow related to clinical laboratory tests performed during patient medical visits or at bedside by ward staff and move the lab results locked inside proprietary systems to a specific patient's records.
A new and unexpected participant at the Connectathon in Oxford this year was Roche Diagnostics (Basel, Switzerland), whose engineers were there for LPOCT validation.
Initially driven by the demand for compatibility among radiology units, IHE has grown by developing technical frameworks, testing tools and integration profiles defining eight distinct areas, or domains, within healthcare including cardiology, patient care coordination and laboratory, for example, as well as the dominant radiology and the growing domain of infrastructure.
Supported by both manufacturers of health systems and IT users, such as regional hospitals, professional medical societies and governmental agencies, IHE uses a collaborative method for integrating different standards for data.
Compliance with IHE specifications is voluntary, yet the broad-based development of IHE specifications has won the formal endorsement of specifications in certain domains by France, Italy, the Netherlands and Finland.
In Austria, a national IHE organization was created this year by the health ministry.
Many vendors in Europe selling medical devices within these national systems will increasingly require a proof of compliance with IHE workflows for their hospital departments to satisfy workflows set forth in requests for proposals.
On a larger scale, IHE-Europe will be a partner for the Large-Scale European Pilot for e-health that is to receive funding from the European Union later this year and when developed will see the exchange of shared patient identification, emergency medical summaries and medication histories between eight to 12 nations.
A GE Healthcare (Waukesha, Wisconsin) executive told BB&T that the handwriting is on the wall for European medical device manufacturers, the proof seen with early adopters at Connectathon testing data exchanges using the upgraded profile for Cross-Enterprise Document Sharing (XDS) that takes advantage of new web service technologies.
Vendors participating in the event ranged from giants like Agfa (Mortsel, Belgium), GE Healthcare and Siemens (Erlangen, Germany) to single-product suppliers of healthcare systems whose sales are exclusive to a single national program.
More informally called a "plug-fest, each supplier at a Connectathon is required to hook up with three competing systems to either push or pull data to demonstrate compatibility. More than 1,850 such tests were conducted over the five days in Oxford.
Only one medical device was physically present and there were several screens for radiology imaging. Instead the testing is virtual, with hundreds of laptops loaded with device software hard-wired to the internet pulling data from remote servers that either simulated hospital IT systems or were actual hospital IT systems participating in the event.
Poiseau said Connectathon presents a unique opportunity for medical device manufacturers to identify and solve problems on the fly during the event. "The cost of fixing a bug during a Connectathon is about 10 times less than the cost of a bug identified on a customer's site, he said.
Record funding in Scotland for care settings and informatics
The National Health Service for Scotland (Edinburgh) reported record funding for capital expenditures in a three-year package totaling 1.6 billion ($3.1 billion) that aims "to ensure that we have a health service infrastructure fit for the 21st century, said Nicola Sturgeon, secretary for health and wellbeing.
In the first wave of funding released for this year, some 324 million ($646 million) will go to build new "fit-for-purpose facilities and to improve existing facilities.
Significantly, another 201 ($401 million) or 40% of the funding is earmarked for e-health infrastructure and augmenting primary care and community care premises, a substantial investment in shifting care out of regional hospital centers and toward local care settings.
For example, two new projects in the NHS Highlands region include a 24-bed community hospital at Bonar Bridge in Sutherland and a new day surgery center at Raigmore Hospital (Inverness).
With the fresh funding, the Scottish Ambulance Service (Edinburgh) will be buying new vehicles and defibrillators. And large-scale projects funded under the three-year program include redesign of facilities at Borders General Hospital (Melrose) and a new emergency care center for Aberdeen.
TomoTherapy to purchase Chinese manufacturer of linear accelerators
TomoTherapy (Madison, Wisconsin), maker of the Hi Art radiation therapy system, said it has entered into an agreement to acquire privately held linear accelerator manufacturer Chengdu Twin Peak Accelerator Technology (Chengdu, China). Financial terms were not disclosed.
A linear accelerator is a key component in radiation therapy systems, used to create high-energy X-rays for cancer treatments. The linear accelerators designed, developed and manufactured by Twin Peak will be used to supplement TomoTherapy's existing supply source, the company aid.
TomoTherapy CEO Fred Robertson said, "The acquisition of Twin Peak represents a substantial advance in our ability to control the quality and features of our products. This also is a piece of our longer-term strategy of reducing the cost of the Hi Art treatment system to improve margins.
TomoTherapy said it anticipates that the transaction will close in about 90 days.
TomoTherapy describes its Hi Art system as an advanced radiation therapy system for the treatment of a wide variety of cancers. The system combines integrated CT imaging with conformal radiation therapy to deliver treatments with speed and precision while reducing radiation exposure to surrounding healthy tissue.
Medco Health in pact with Swedish firm Apoteket
Medco Health Solutions (Franklin Lakes, New Jersey) reported collaboration with Sweden's government-operated retail pharmacy authority, Apoteket (Stockholm), to "develop and test the first automated electronic prescription-review system to improve clinical and financial outcomes for Swedish patients and the country's healthcare system.
Medco and Apoteket will jointly develop a customized system to perform safety checks on each prescription prior to dispensing — warning pharmacists of drug interactions, excessive dosing or any other issue related to dispensing a prescription.
Medco said such drug utilization review systems are commonplace today in the U.S., but do not exist in many other countries.
In Sweden, it is estimated that 30% of total emergency care visits and 10% of all hospital admissions are the result of prescription drug-related issues.
"As more patients in Sweden are routinely treated by larger numbers of doctors, and in the future they may use different pharmacies, this system will provide a safety net for patients and their physicians, who may not be aware of all the medicines that may have been prescribed by other clinicians, said Erik Thorsell, Apoteket's executive for quality assurance.
Currently, all Swedish pharmacies are operated by Apoteket, the government entity responsible for prescription pharmacy care nationwide. The new system is being developed as Sweden moves toward deregulating the retail pharmacy market in 2009.
1st procedures conducted in Japan with Powerlink
Endologix (Irvine, California), maker of the Powerlink System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), said the first two procedures with the company's Powerlink System have been performed in Japan after it received Shonin approval.
Both procedures were performed at Osaka University Hospital early in April by Toru Kuratani, an assistant professor of cardiovascular surgery. The first case was a patient with an AAA, complicated by a narrowing of the left common iliac artery; the second case featured an anatomy that included a calcified stenosis of the aorta just above the aneurysm.
Implantation of the Powerlink device took one hour in the first case, 40 minutes in the second.
The clinical trainer for the first cases was Satoshi Kawaguchi, assistant professor of vascular surgery at Tokyo Medical University Hospital and a primary investigator of the Powerlink system in the Japanese clinical trial.
"I believe the unibody design of the Powerlink simplifies the implant procedure by eliminating much of the guidewire manipulation required to implant multi-piece systems, Kawaguchi said. "I also believe the design will reduce the risk of late problems associated with stent graft migration.
The Japanese clinical trial was conducted at Tokyo Medical University Hospital, Tohoku University Hospital, Fukushima Medical University Hospital, Tokai University Hospital, Yamaguchi University Hospital and Kurume University Hospital.
Paul McCormick, president/CEO of Endologix, said, "In the U.S. the Powerlink was the fifth stent graft to obtain marketing approval, five years behind the first approved device. In Japan, the Powerlink System is one of only three approved commercial stent grafts and our approval came only 14 months following the first device approval.
He estimated that 14,000 open repair surgeries for AAA are performed annually in Japan, adding: "It is more of a level playing field as we launch in Japan and we believe that bodes well for product adoption.
Approval from the Japanese Ministry of Health, Labor and Welfare for the Powerlink System was received in early February; reimbursement was announced on March 31.
Remaining questions still remain for Biopure's Hemopure
Biopure (Cambridge, Massachusetts) reported the receipt of a comment letter from the UK's Commission on Human Medicines addressing the company's application for marketing authorization for Hemopure [hemoglobin glutamer — 250 (bovine)] pending with the Medicines and Healthcare products Regulatory Agency (MHRA).
The company said the letter states that the commission was "reassured on a number of the questions raised in its initial comment letter, but indicated that other pharmacological and clinical issues either were not yet resolved by the submission made by Biopure last November or were resolved only in part.
The comment letter posed several new questions and invited Biopure to discuss the issues with the MHRA team of medical, statistical and pharmaceutical reviewers.
The company said the commission has not advised it to withdraw the application. Biopure said it has been advised that such a request would be the customary means of indicating futility or rejection of an application.
Japanese licensing deal for test kit maker Corgenix
Diagnostic test kit maker Corgenix Medical (Denver) reported a licensing agreement with the Okayama Prefecture Industrial Promotion Foundation in Japan covering new diagnostic technology for serum amyloid protein (SAP), an important serum biomarker for cardiovascular inflammation.
The technology was developed by Eiji Matsuura at the Graduate School of Medicine, Dentistry and Pharmaceutical Sciences of the University of Okayama.
Corgenix reportd that it has had alliances with researchers and academic institutions in Okayama since 2001. The company's AtherOx technology was developed in collaboration with researchers from the University of Okayama.
The company said this new agreement "opens additional avenues of technology and strengthens the collaboration with the Okayama Prefecture [a prefecture being the equivalent of a state] aimed at developing innovative and important diagnostic products in the future.
EnCor breast biopsy system launched in several countries
SenoRx (Aliso Viejo, California) said it has launched EnCor, its flagship vacuum-assisted breast biopsy product, and its line of breast biopsy tissue markers in additional countries outside the U.S.
The company said its products now will be marketed through distributors in Germany, France, Italy, Russia and the Nordic countries.
SenoRx had previously reported in October 2007 that it was partnering with local distributors with breast imaging and/or interventional radiology franchises in Austria, Belgium, the UK, Hong Kong, Ireland, Luxembourg, the Netherlands, Singapore, Switzerland and Taiwan.
EnCor and SenoRx breast tissue markers have previously received the necessary regulatory clearances in the European Union and several other countries in Asia.
"Following successful test marketing of EnCor in several countries outside the United States early last year,we began establishing agreements with selected distributors to sell EnCor and our line of tissue markers said Lloyd Malchow, SenoRx president/CEO. " "We indicated at that time that we intended further expansion of our marketing efforts in additional countries beginning in 2008.
Arbios launches process toward CE mark for SEPET System
Arbios (Waltham, Massachusetts) said it has engaged the British Standards Institution (BSI; London) — terming it "one of the leading notified bodies in Europe — to assist the company in its effort to obtain a CE mark for its SEPET Liver Assist Device.
CE marking would allow sale of the SEPET — a sterile, disposable cartridge with proprietary membrane permeability characteristics for use in treating patients with chronic liver failure — within the 28 countries of the European Union and three additional countries in the European Free Trade Association.
"We ... look forward to advancing our market approval and product acceptance strategy for SEPET in Europe, said Shawn Cain, president/CEO of Arbios. "Based on guidance from BSI, we will seek approval of SEPET using data from our recently completed feasibility trial. If no additional clinical data are necessary, and if we meet all the requirements for CE marking, we believe that our CE-mark filing for SEPET will be completed by the beginning of 2009.
He added that the company is seeking a European distribution, marketing and sales partner to assist in introducing the product in Europe.
When a patient's blood is passed through the SEPET fibers, blood plasma components of specific molecular weights are expressed through the micropores, cleansing the blood of harmful impurities, including hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration.
These substances otherwise would accumulate in the patient's bloodstream during liver failure, causing hypotension, increasing risk of sepsis and accelerating damage to the liver, lungs and other organs such as the brain and kidneys — and suppressing the function and regeneration of the liver. SEPET is designed for use with standard blood dialysis systems available in hospital intensive care units.
Arbios said there currently is no satisfactory therapy available to treat patients in liver failure, other than maintenance and monitoring of vital functions and keeping patients stable via the provision of intravenous fluids and blood products, administration of antibiotics and support of vital functions.
Given, Olympus settle lengthy endoscopy patent lawsuit
Given Imaging (Yokneam, Israel) and Olympus (Tokyo) reported last month that have signed a term sheet to settle their lengthy patent lawsuit in U.S. over their capsule endoscopy products.
The technology enables a patient to swallow a pill with an integrated camera, which makes its way through the gastrointestinal tract and captures images that a doctor can assess on a screen.
The term sheet includes:
• worldwide cross-licenses under which each party receives a royalty-free license under all existing patents of the other party for its respective existing capsule endoscopy products.
• an exchange of covenants not to sue on currently available medical device products
• a release of all past causes of action.
• a cross-license under existing and future patents of each party for future capsule endoscopy products,
• a payment of $2.33 million to Given
• an agreement to cooperate in future joint market-development projects.
FDA clearance for oxygen level brain monitor won by OrNim
OrNim Medical (Lod, Israel) reported receiving FDA clearance for its CerOx device, making a giant step closer to bringing non-invasive, real-time, dynamic monitoring of oxygen levels in the brain into the medical toolkit. A start-up firm, OrNim says CerOx is its flagship device, describing it as "simple and user friendly.
The device's sensors adhere to the skin of the forehead with a single-use adhesive, then attached by electro-optic cables to a stand-alone bedside monitor that displays current and historical patient data from two fields simultaneously as a percent of oxygenation in the area of focus. Using Ornim's Ultrasound Tagged Light technology ultrasound demarcates the area being monitored, enabling localized measurement of average oxygenated and deoxygenated hemoglobin absorption.
Revital Shechter, president, VP of R&D and a company co-founder with CEO and chief technology officer Michal Balberg, said "Our 'targeted oximetry' is far more safe and less expensive than current devices on the market.
Static measuring methods require drilling through the skull to insert electrodes into the cranial vascular bed, or taking blood samples from the jugular vein bulb, draining venous blood for laboratory analysis.
"We can get accurate, repeatable, and ongoing results in patients who need it most: unconscious, after head trauma, or during general anesthesia, Shechter said, adding that the company's first market target will be for trauma and emergency medicine units, in hospital and in the field "where the need for a direct, absolute measurement of oxygen saturation in tissues and continuous monitoring is most urgent. Other applications of the Ornim's targeted oximetry include muscle, kidneys, sepsis, peripheral vascular disease, ischemic wounds and the company's initial application effort, fetal distress.
Since OrNim's founding in 2004, it has raised $3 million from Gilo Ventures (Los Gatos, California), headed by Israeli David Gilo and Gil Perez. Balberg said, "We are now entering a $7 million round, with $2 million secured from Gilo Ventures and private investors.
This is Gilo Ventures' second medical company investment, following $20 million placed in 2000 in Stentor (San Francisco, California), a leader in PACS development for managing CT, X-ray, and digitized images.
Initial marketing of the CerOx is planned to begin in 2009, with CE-mark certification and FDA clearance, after conducting clinical trials on head trauma patients in Israel and San Francisco.
• Boston Scientific (Natick, Massachusetts) said the Japanese Ministry of Health, Labor and Welfare has approved its Acuity Steerable left ventricular lead for use with cardiac resynchronization therapy (CRT) devices to treat heart failure.
The company also received reimbursement approval for the lead from the National Health Insurance System and said it plans to launch the product immediately in Japan.
The Acuity Steerable left ventricular lead features a deflectable tip for delivery in "simple, compound and complex anatomies, Boston Scientific said, which includes placement of the lead in difficult-to-access branch vessels on the left side of the heart.
Fred Colen, executive VP, operations and technology, at Boston Scientific's Cardiac Rhythm Management business, said, "The Acuity Steerable lead, when teamed with our CRT devices, provides a proven, effective treatment option to patients who struggle with heart failure.
The Acuity Steerable lead also provides physicians with four configurations for stimulating the left side of the heart, which the company refers to as Electronic Repositioning.
"This ... allows physicians to change the stimulation site non-invasively after implant, which helps avoid the need for an additional surgical procedure, The company said. "[We are] the only company that provides physicians with four left ventricular pacing configurations.
• GammaStar Medical Group (Shanghai, China) said that following more than a year of development, the company's Gyro Knife product for cancer radiotherapy has been awarded the CE mark. Calling the action "a true milestone with a long-term strategic meaning for the group, GammaStar said the certification "shows the improved safety, effectiveness and advancement of the Gyro Knife in the eyes of the authorities of international markets.
The company in a statement said the safety of the Gyro Knife "is ensured by its unique safety interlock mechanism.
Emergency stop switches are installed on the console and in the radiotherapy room, an interlock switch is installed on the shielding door of the radiotherapy room, a collision detecting switch is on the front end of the treatment head of the frame, plus limit switches for three movement directions of the patient support, as well as multiple interlock mechanisms such as voltage detecting interlock, detecting interlock for beam on/off failure, treatment mode interlock and timer failure interlock, all of which can ensure that the equipment is absolutely safe during usage.
The radiation source of the Gyro Knife has a double-layer sealed structure and "in the treatment room, there is an environmental detecting instrument, the alarm of which will ring when radiation of the radiation source exceeds acceptable standards, GammaStar said.
"At the same time, it added, "the operator is provided with a personal detection device of radiation levels and will test the equipment regularly to ensure safety and reliability of equipment and components.
• Onset Medical (Irvine, California) said it has received the CE mark for its SoloPath trans-septal access catheter, enabling marketing in the European Union and select other countries worldwide.
SoloPath features Onset's Controlled Deployment Technology (CDT), to allow percutaneous access to the chambers of the left heart and surrounding vasculature. Onset, a private company, says it has developed several product platforms based on CDT, which represents what Onset terms "a new and different approach to procedures requiring minimally invasive access to remote sites within the body.
The company said CDT "allows introduction of a dimensionally small catheter to a specific site, which once positioned, can be radially expanded to deploy a semi-rigid sheath to maintain access to the treatment site.
The catheter enters the body at a diameter roughly 50% of the size of conventional access devices. "Once placed in the body, the device is expanded in a slow and gentle manner, using radial force to create an internal diameter larger than conventional devices, the company said. It added that studies have shown that the CDT "can allow the physician to achieve access quicker, easier and with less trauma to the surrounding tissue than with conventional access procedures.
SoloPath, the first cardiovascular application of Controlled Deployment Technology, allows interventional cardiologists and electrophysiologists a percutaneous approach to access the left atrium and pulmonary veins through the atrial septum for the diagnosis and treatment of conditions such as atrial fibrillation.
The company says that plans are under way for commercialization of the device in the second half of 2008.
• Medtronic (Minneapolis) reported receiving the CE mark and launching in the European market its Defender embolic protection filter for use during minimally invasive procedures in carotid arteries and saphenous vein grafts. The first uses of the new filter were carried out recently by interventional cardiologists and vascular surgeons in Germany and Spain, the company said.
Made of braided nitinol, a so-called "memory metal that resumes its original shape upon deployment, the Defender filter has a low profile and a peel-away delivery sheath that enables physicians to maneuver the device easily across lesions to the desired location, according to the company.
When opened, the filter acts as a basket, allowing sufficient blood flow while simultaneously trapping embolic debris that may become dislodged during a stenting procedure. Without this protection, said Medtronic, embolic debris can flow into other portions of blood vessels — which can lead to a stroke.
The company noted that hundreds of thousands of patients, worldwide, undergo cardiovascular procedures to improve blood flow each year, many involving the implantation of stents.
Rob ten Hoedt, VP of the CardioVascular business for Medtronic in Western Europe, said the Defender filter now is available throughout the European Union. "While designing the Defender filter, we conducted extensive research with physicians to understand their needs and what they felt were the most important qualities in an embolic protection device, ten Hoedt said. "They told us they needed a filter that is easy to use, with excellent deliverability and a low crossing profile to minimize the risk of dislodging debris when they cross a lesion.
Andrej Schmidt, MD, of the department of clinical and interventional angiology at the University of Leipzig Heart Center (Leipzig, Germany), said, "For me, the most important attribute for a filter is its crossing profile, and Defender has one of the lowest profiles available on the market.
The Defender filter has a 2.2 Fr (0.029) crossing profile and an extendable 0.014 stainless steel core wire that is designed for both flexibility and support, Medtronic said in a statement.
"The device's mesh filter basket design allows the filter to fit snugly against vessel walls, even in eccentrically shaped vessels. This reduces the risk of embolization by preventing particles from migrating through gaps and into the bloodstream, according to the company.
• 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.
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.
In addition, acoustically differentiated alarms and information displayed on the touch-screens describe the status of all monitoring functions of the extracorporeal circuit.