PARIS — The accent was on telemedicine in the Innovation Center of the general practice expo, MEDEC, held here mid-March.

As elsewhere in Europe, hospital capacity is challenged in France, yet the promotion of prevention and pre-emptive intervention is a fairly recent development at the national level. Telemedicine constitutes an essential first-response tool, enabled by a robust telecommunications network that shifts the information infrastructure off a reliance on hospital-based IT to the established protocols for GSM and IP.

Telecommunications operator Orange Internet Sant (Health Internet), a unit of France Telecom (Paris), shared a co-branded promotion with two manufacturers of products recently launched in France, a geo-positioning bracelet from Medical Mobile, the French subsidiary of Medical Intelligence (Quebec City) for reporting the whereabouts of Alzheimer's patients, and a hand-held, web-based log for diabetes patients from Voluntis (Paris).

Medical Mobile said more than 2,500 of the company's Columba bracelets for Alzheimer's patients have been sold since September, when the kit became available in pharmacies, as well as boutiques of France Telecom and Orange.

Orange Internet Sant has stolen the march on software providers in offering a secured network for almost 100,000 subscribing healthcare providers to transfer files and e-mails. Significantly, general practitioners and clinics in France are comfortable with GSM transmissions thanks to the national health smart card, Carte Vitale 1.4, and the terminals on every doctor's desktop that transmit patient information for both payment and reimbursement.

Another product linked with Orange is the insulin monitoring program from Voluntis, which is based on its Medpassport software suite for patient-relationship management.

Credited as a developer of the diabetes application of the Medpassport platform is Dr. Guillaume Charpentier, head of the diabetes research center at Sud-Francilien Hopital in the Paris suburb of Corbeil-Essonnes. He tested the system with 30 patients aged 16 to 62 over a three-month period and reported a 100% satisfaction rating.

"We are trying to imitate the function of the pancreas," Charpentier said. "Where previously a patient tried to adapt meals according to an insulin dosage, here we can adapt the dose according to the meal."

Using a personal data assistant (PDA) running Windows Mobile, the patient records the gylcemia levels of food consumed, along with any other relevant information such as activity level, and is immediately shown an appropriate insulin dosage according to parameters set by the physician. The data is automatically uploaded to an Internet-hosted database that can be monitored by clinical staff, referred to by the physician, or shared with other physicians. The Medpassport program creates charts and features a patient dashboard for monitoring this complex condition.

The new PDA-based product for Type 1 diabetics was supported by Sanofi-Aventis (Paris), and upgrades the DiabCarnet program launched in 2003 by Voluntis for Aide aux Jeunes Diab tiques (Assistance for Young Diabetics; Paris), which has attracted several thousand users.

The DiabCarnet program continues under the sponsorship of Abbott Laboratories (Abbott Park, Illinois), Roche Diagnostics (Basel, Switzerland), Johnson & Johnson (New Brunswick, New Jersey) and Novo Nordisk (Princeton, New Jersey).

The insurer AXA Assistance (Issy-les-Moulineaux, France) also has adopted the Medpassport platform for its patient-relationship management to assure medication compliance.

Voluntis reported 1600,000 ($810,000) in sales for 2006 and in January secured 12 million ($2.7 million) in funding to further product and market development in Europe.

Industry faces big challenges in move from micro to nano

"Ideas about nanotechnologies are far more numerous than nano-products," noted Professor J rge Vienken during his presentation at MEDTEC Stuttgart last month. Before an audience that included some who have won international reputation for their mastery in machining devices measured in microns, or one-millionth of a meter, Vienken offered a tour de force of recently developed materials used for medical devices that are measured a full magnitude lower at one-billionth of a meter, or in nanos.

Vienken, VP-biosciences at Fresenius Medical Care (Bad Homburg, Germany), was part of a day-long session at MEDTEC devoted to "Materials and Nanotechnology" that ran parallel with sessions on advanced manufacturing.

The question posed by this professor from the laboratory to the nuts-and-bolts manufacturers fresh off the shop floor was blunt: "How can we work with these materials when microscopes do not have the resolutions to see these elements?"

"We need tools," he said, pointing to an image representing an impossibly tiny nano fiber emerging from an extrusion nozzle with a pair of scissors super-imposed.

The issue is no longer academic. As applications for nanotechnologies in diagnostics and therapies move from the possible to the proven in laboratory projects, the device industry faces an emerging, and disruptive, challenge to a core competency.

InterGenetics’ OncoVue test is released in UK, Ireland

InterGenetics (Oklahoma City), a predictive medicine company focused on molecular diagnostics and targeted therapy for cancer, reported the international release of OncoVue, which it said is "the first genetic-based, breast cancer risk test that incorporates both personal history and gene-based information to determine a woman's future breast cancer risk."

Opaldia (London), a genetic health service provider with a network of clinics, will release OncoVue in the UK and Ireland under an exclusive agreement with InterGenetics.

The OncoVue test is easy for women to take, according to the company. They first answer a simple medical history questionnaire, then swish a mouthwash and deposit the fluid into a tube.

In the InterGenetics' laboratories, DNA from the woman's cheek cells in the mouthwash are analyzed using the OncoVue CombiSNP technology that looks at combinations of genes, rather than any single gene alone.

Research has shown such gene and personal history combinations have a significant relationship to women diagnosed with "sporadic" breast cancer, the type of breast cancer affecting 90% to 95% of all women, according to the company. The research also reveals a strong dependence on age for genetic contribution to breast cancer risk.

The test has been developed even for women who do not have a strong family history of cancer, about 85% of the women who get breast cancer. Opaldia will promote OncoVue in the UK and provide genetic counseling and other breast surveillance services in tandem with the testing.

InterGenetics and Opaldia will jointly participate in the development and sharing of best practice protocols for OncoVue in the UK and Irish markets.

The OncoVue test has been released in the U.S. under an FDA-approved investigational device exemption study conducted by InterGenetics at 12 "comprehensive" breast centers and individual physicians' practices in 10 states.

Novadaq gets Japanese patent for its SPY imaging system

Novadaq Technologies (Toronto, Ontario) reported receiving a patent in Japan for its SPY Intra-operative Imaging System, enabling the visualization of the flow of blood through grafts during bypass procedures.

The Japanese patent, No. 3881550, assigned to the National Research Council of Canada (Ottawa) and exclusively licensed to Novadaq, is titled "Method and Apparatus for Performing Intra-operative Angiography."

Novadaq said the patent protection for the core imaging technology in Japan represents "a major commercial breakthrough" for the company, reinforcing its global strategy to build a strong portfolio of protection for its existing products and those emerging from its pipeline. It said it "further strengthens Novadaq's position as the imaging company of the operating room."

The SPY Intra-operative Imaging System, available worldwide, is designed to enable cardiac surgeons to visually assess coronary vasculature and bypass graft functionality during open-heart surgery.

Novadaq's OPTTX System, which received CE-marking last November, is aimed at the diagnosis, evaluation and treatment of wet age-related macular degeneration by using the same core imaging technology that is used in the SPY System.

CE mark, 1st implants reported for Sorin's Reply pacemakers

The Sorin Group (Milan, Italy) reported CE-marking and first implants of its next-generation Reply pacemakers, calling them "the world's smallest dual-chamber devices" at 8 cc. The new line is de-signed to deliver automatic, physiologic pacing adapted to patients who have bradyarrhythmia, slow ventricular rhythms.

The Reply pacemakers integrate Sorin's SafeR pacing mode that constantly monitors a patient's natural cardiac activity and reduces the amount of pacing delivered to the right ventricle, thereby promoting natural cardiac function.

The company said unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation, potentially fatal conditions and a heavy cost burden on healthcare systems.

While conventional pacemakers deliver unnecessary ventricular pacing in patients without heart block 50% to 80% of the time, Sorin says that SafeR reduces pacing in the ventricle to less than 0.1% in these patients.

The SafeR technology builds on Sorin's AAIsafeR mode, which the company calls the first pacing mode designed to limit unnecessary ventricular pacing that was available in a pacemaker. AAIsafeR was launched in September 2003 in Europe and received FDA approval in May 2005.

Sorin says it was the first company to receive U.S. market clearance for a pacemaker incorporating a pacing mode that minimizes ventricular pacing.

In addition to SafeR, Sorin said the Reply pacemakers feature advanced, automatic features that provide easier patient management by simplifying device checks.

UK issues major proposals for regulating health professionals

The UK government has published a White Paper outlining what it described as "landmark proposals" on how to regulate health professionals and ensure patient safety.

Once adopted, the plan will require all health professionals to prove their fitness to practice every five years. There also are plans for an overhaul of the processes for death certification.

Based on consultation on the chief medical officer's review of medical regulation and the accompanying review of other professions, the main proposals in "Trust, Assurance and Safety, The Regulation of Health Professionals in the 21st Century" include:

  • Professional regulators independent of the government and led by an equal partnership of independently appointed professionals and members of the public;
  • All health professionals required to demonstrate periodically that they are fit to practice by revalidating their professional registration;
  • A move from the criminal standard of proof to the civil standard in fitness-to-practice cases;
  • A stronger role for the medical Royal Colleges.
  • Introduction of a system of regional GMC Affiliates providing support to local employers to address concerns about doctors and independently quality assure local revalidation.

The document includes proposals that "will ensure patient, public and professional confidence in the health professionals' watchdogs, improving patient safety and ensuring the fair treatment of health professionals," the government said.

CellSearch system is launched in Hong Kong

The CellSearch System, an advanced prognostic platform for analyzing circulating tumor cells (CTC) in metastatic breast cancer patients, has been launched for commercial application in Hong Kong.

The system is provided by Bridgetech Hong Kong, a wholly owned subsidiary of Bridgetech Holdings International (San Diego), which is involved in the transfer of Western medical technology to China, with an initial focus on oncology.

Bridgetech has installed two sets of the CellSearch System in Hong Kong, at the University of Hong Kong and the Chinese University of Hong Kong, and the former is now available for use by metastatic breast cancer patients. Requiring as little as 7.5 ml of a patient's blood, the system can perform the capture, identification and classification of CTCs in an automatic, standardized and scientific manner.

The company said CTC tracking and analysis provide prognostic information for predicting progression-free survival and overall survival of metastatic breast cancer patients.

Cell-cultivation systems agreement in works

Cinvention (Wiesbaden, Germany) and Instrumentation Laboratory (Lexington, Massachusetts) said they plan to enter into a distribution and marketing partnership to market Cinvention's nano-structured bioactive carrier systems for cell cultivation in biomanufacturing and tissue engineering. The products are known under the brand names CarboScale and CarboSeed.

Formerly known as Blue Membranes, Cinvention has developed a portfolio of products for cultivating mammalian cells on bio-mimicking nano-structured carbon moulds used in conventional bio-reactor systems. These carrier systems provide tissue-like surfaces attracting cells to attach and proliferate on the bioactive surfaces.

Compared to conventional cultivation systems, Cinvention said its products allow increasing yields up to 8%. The materials for attaching cells are disposables and available both as beads and structured packings. The increase of surfaces by nano-structuring and embedding flow-channels into the structured packings allows increasing the overall surface area of up to 10,000 square meters per 100 ml of cell cultivation volume.

Cinvention has two business units: medical device coatings and bioprocessing. The company has launched nano-composite carbon-coatings for drug-eluting stents that are expected potentially to overcome the current issues surrounding polymer-coated stents, namely late thrombosis.

Instrumentation Laboratory, which is part of the CH-Werfen Group, is a manufacturer of in vitro diagnostic instruments, reagents, controls, consumables and services, for use primarily in hospitals and clinical laboratories.

Averion International opens four European offices

Averion International (Southborough, Massachusetts), a clinical research organization, has opened four European offices.

The new Averion offices include Averion Europe, near Frankfurt, Germany, which will provide financial, administrative and operational support for Averion's European operations; Averion Ltd., in the UK, which will oversee operations for Averion's clinical trials in northwestern Europe and coordinate activities with the company's UK-based clients; Averion Clinical Research, in Austria, with responsibility for Central and Eastern European operations; and Averion Sp. z.o.o., in Poland, which will provide operational support and coordination of studies in Poland and the Baltic States.

Averion International provides clinical research and regulatory compliance/validation services to the pharmaceutical, biotechnology and medical device/diagnostic industries. It has a therapeutic focus in oncology, dermatology, nephrology and medical devices.

First Hugs systems installed in Portugal

VeriChip (Delray Beach, Florida), a provider of radio frequency identification (RFID) systems for healthcare, said it has completed the installation of its first three Hugs infant protection systems in Portugal.

The installations represent the company's first sales for the system in continental Europe. Overall, VeriChip reports having sold 15 Hugs infant protection systems in international markets.

The Hugs systems were installed in Hospital da Luz (Lisbon), Hospital Sao Joao de Deus-V.N. (Famalicao) and Hospital de Sao Teotonio-Viseu (Maia) by Safesis (Maia), the Iberian partner of Australian-based Austco Communication Systems, the primary international distributor for VeriChip in all markets outside the U.S. The Hugs system is CE-marked.

VeriChip is majority-owned by Applied Digital (Branson West, Missouri).

U.S. distribution pact for Dutch company

King Pharmaceuticals (Bristol, Tennessee) and Gelita Medical (Amsterdam, the Netherlands) have entered into an agreement under which King received an exclusive license to distribute Gelita's absorbable gelatin sponge in the U.S. Gelita will manufacture and supply the hemostatic product to King. King's Thrombin-JMI, a topical active hemostatic agent, is used by surgeons together with a variety of passive hemostatic agents, including absorbable gelatin sponges.

Absorbing 50 times their own weight, Gelita's hemostatic products stop bleeding fast, generally within two minutes.

King said it plans to begin marketing Gelita's absorbable gelatin sponge in the U.S. after the product receives FDA approval for use during surgery. The license also provides King an exclusive option to acquire U.S. commercialization rights to any new hemostatic products developed by Gelita.

Accord signed on fluorescent reagents

AbD Serotec, a division of MorphoSys (Munich, Germany), and Thermo Fisher Scientific (Waltham, Massachusetts) have signed an agreement covering the use of Thermo Scientific's DyLight Dyes in combination with AbD Serotec's research antibodies to prepare a series of fluorescent reagents. The resulting products will be available through the AbD Serotec sales catalog. Financial details of the accord were not disclosed.

"Fluorescent antibodies are particularly suited for detection of specific antigens in tissues or on cells and have become an indispensable tool for scientists worldwide," said Dr. Achim Knappik, senior director of R&D at AbD Serotec.