BB&T European Editor and Staff Reports

PARIS – Innovation in medical technology over the past 10 years has led to an unbroken stream of product introductions.

The stream has become a flood that is inundating healthcare systems with so many new technologies and dazzling devices that care givers, clinicians and hospital procurement executives are drowning in choice.

In Europe local health authorities have initiated diverse forms of Health Technology Assessment commissions to assess and recommend appropriate technologies.

National health ministries, which have wildly different levels of real authority across Europe's 280-plus autonomous regions, provide a variety of lists to help set priorities for limited procurement budgets.

Two sets of rankings for medical devices were released recently to add weight, and a little perspective, for what is important among myriad medical machines and systems.

In early July, the World Health Organization (WHO; Geneva, Switzerland) reported the selection of 15 technologies that address global health concerns.

Meanwhile, in June the leading German association of medical device manufacturers, BVMed (Bundesverband Medizintechnologie; Berlin) published its list of “The 10 Most Important Lifesavers of Medical Technology“ complete with annual usage rates for each device.

The contrast in selected devices could not be more stark between the humanitarian agenda and the manufacturer's perspective.

Equally interesting is the contrast between WHO's wistful wish-list filled with promised but unproven benefits and a very German emphasis by the manufacturing association on the actual number of lives saved by the selected hardware.

The WHO project, Priority Medical Devices, began in 2007 in collaboration with the government of the Netherlands to determine whether medical devices currently on the market were meeting the needs of health care providers and end-users throughout the world and if not, to identify and remedy shortcomings.

The goal of the project is to identify gaps in the availability of preventive, diagnostic, therapeutic and assistive medical devices on the market and to help guide government public health spending.

While WHO says its assessment includes health technologies ranging from single-use devices to the most advanced MRI scanners, the first 15 selected products are decidedly low-tech devices with an emphasis on addressing widely prevalent treatments for use in resource-limited settings.

Eight products were selected in the category for commercialized products, satisfying a requirement that they have been available for less than five years in high-income countries and are not yet widely used in low- and middle-income countries.

Three of the products target care for newborn infants, including use of a transcutaneous bilirubin measurement system as an alternative to blood sample analysis for the diagnosis of hyperbilirubinaemia and a light-emitting diode phototherapy unit to treat hyperbilirubinaemia.

There is also a reusable neonatal suction system that operates without electricity to remove obstructive mucus from the air passages in newborns.

Other selected commercial devices include a fluorescence visualization system for cancer screening and a wound irrigation device to treat traumatic injuries, post-natal infections and neglected tropical diseases.

In a second category for products that are under development, WHO selected a solar-powered autoclave unit to sterilize medical instruments in remote rural areas, a portable infant warmer that does not require electricity, and a lab-on-a-chip cell sorter and counter for rapid automated screening of a blood samples for HIV and malaria diagnosis.

The 15 medical devices selected satisfy a definition of “innovative“ by providing evidence that the instrument, device, implant or disposable has not previously existed, has not previously been made available in low- and middle-income countries, is safer or simpler to use than earlier solutions, and is more cost effective than previous technologies.

The final report of the Priority Medical Devices project, “Medical Devices: Managing the Mismatch“ is expected to be published later this year.

The first Global Forum on Medical Devices organized by WHO will be held Sept. 9-11 in Bangkok, Thailand.

The manufacturing association has a very political agenda as tensions mount in Germany ahead of what is expected to be a divisive debate over austerity measures for state budget reductions.

The creation by BVMed of a Top 10 list for medical devices is part of a larger public information campaign that aims to keep funding for medical innovations, whether in reimbursement plans or for start-up funding, at the forefront among parliamentarians and policymakers.

The number of lives affected annually is provided for each device listed.

Cardiac disease dominates the list with five devices ranging from mild to extreme treatment.

Stents for propping open clogged coronary arteries lead the list with 320,000 devices used each year.

Pacemakers were ranked third with 100,000 patients annually.

Implantable cardiac defibrillators was listed as seventh with 30,000 devices annually.

Cardiac valves were ranked eighth with 20,000 devices used each year, a special mention being given to the innovation of transcatheter implantation of aortic valves.

Artificial heart-assist technologies, such as ventricular assist devices, complete the BVMed list in tenth place with 500 patients connected to a machine either as a bridge-to-transplant or as a destination therapy.

An unexpected second-place on the BVMed list was awarded to catheter and port devices for artificial feeding and nutrition for the 140,000 patients in Germany suffering stroke, end-stage cancer or other complications that prevent normal feeding or obstruct digestion.

Dialysis therapy was won fourth on the association's list as 80,000 patients depend on the treatment.

The range of respirators, warmers and specialized devices used for neo-natal infant care were ranked fifth affecting 63,000 deliveries each year.

The less-invasive innovation of needle-aspiration breast biopsy affects 35,000 women each year earning a sixth place ranking for this medical technology.

Carotid stenting for the prevention of strokes was listed in ninth place with 8,000 patients treated each year.

Micro-optimism among nano manufacturers

For the moment it is just a feeling, a rising sentiment that business is picking up.

After enduring two bad years, a majority of the German microtechnology, nanotechnology and advanced materials companies surveyed recently say they are experiencing a turning of the tide.

Half of these businesses supply technologies and services to the medical device sector, dividing their sales evenly between export and domestic customers, according to a January survey of the same group.

Operations in the first half of 2010 were reported better than expected for just over half of the companies, on target for a third, and worse than expected for 15%.

Sales and incoming orders at some companies have regained or even exceeded the level of the first half of 2008, according to the survey findings.

In the first half of 2010, businesses reported sales had risen up to 15%, according to the research division of the IVAM Microtechnology Network that fielded responses from managing directors or project managers at 115 companies.

Companies predicted “a very positive development“ for the second half of 2010 with 53% expecting business to remain stable and 40% anticipating further improvements.

In spite of the generally positive mood, some survey respondents remained reserved, cautioning that market developments remain hard to predict and that there is still room for surprises.

New business model: Out-of-pocket payments

Faced with fewer and fewer options to escape looming budget deficits, Germany is considering the possibility of allowing out-of-pocket spending by patients for medical treatment.

What sounds like common sense to Americans is heretical to the other 99% of health insurance systems in the world that are governed by the state.

Staunch, social-minded countries such as Germany and France created the gold standard for state-run healthcare, which rejects the idea that rich people have access to better healthcare.

In a truly equitable system where everyone pays in, every citizen should be entitled to the same level of care.

Unfortunately, these golden benefits come at too high a price.

Facing a deficit for its Statutory Health Insurance fund of €10 billion ($13 billion) in 2011, German policy makers are open to even radical suggestions, such as direct patient payments.

After a drug cost saving package implemented earlier this year that will bring savings of up to €2 billion ($2.6 billion) combined with short-term cost-cutting measures planned for next year, Germany is still expected to come up €6 billion ($7.7 billion) short of break-even.

With an increase in contribution rates, or premiums, inevitable, the only way forward for patients seeking innovative treatments will be to pay privately for services.

ClariVein system introduced in Europe

Vascular Insights' (Madison, Connecticut) ClariVein occlusion catheter was recently introduced at four medical facilities in Europe.

The device is intended for endovascular occlusion of incompetent veins in patients with superficial venous reflux. ClariVein is a non-thermal approach that uses a mechanical rotating dispersion wire to mix and disperse a sclerosant on the vessel wall to cause ablation of a vein – for example, the great saphenous vein.

The European hopsitals reporting use of ClariVein were Privatklinik Proebstle (Mannheim, Germany), St. Antonius Hospital (Nieuwegein, the Netherlands), Rijnstate Hospital (Arnhem, the Netherlands) and Maastricht University Medical Center (Maastricht, the Netherlands).

Compared to radio frequency or laser therapy, a key advantage of ClariVein is that it does not require tumescence anesthesia, and can be used to treat near nerve bundles without concern for nerve damage, the company said.

Freshmedx forms j-v, brings BSP to Mexico

Freshmedx (Salt Lake City) reported an agreement to form a joint venture (j-v) to bring its Bioconductance Scan Platform (BSP) system to Mexico for patients who are at high risk of developing lung cancer.

The BSP is a non-invasive lung cancer diagnostic system designed to improve the accuracy of pre-surgical lung cancer diagnosis in a 12-minute scan, Freshmedx said. The company noted that this is its first licensing agreement and j-v reported as the result of international discussions that began just a few months ago.

Freshmedx said it intends to engage in local development in hopes of bringing Mexico's at-risk population increased access to life saving and cost effective technologies. The j-v will make the BSP available to all of Latin America in a staged program to be announced later this year, the company said.

Upon approval from the Mexican government, the joint venture plans to enter the market in Mexico and Central America in 2011 .

Cancer patients in Scotland can use RapidArc

One of the UK's largest radiotherapy departments has begun treatments using RapidArc technology from Varian Medical Systems (Palo Alto, California). Four head & neck cancer patients have been treated to date at the Beatson West of Scotland Cancer Center (Glasgow, Scotland).

The advanced RapidArc system, which has been introduced clinically on two Varian Clinac medical linear accelerators, delivers precise image-guided IMRT (intensity modulated radiotherapy) up to four times faster than conventional IMRT, which the Beatson introduced in 2005.

Sanuwave launches orthoPACE in Europe

Sanuwave (Alpharetta, Georgia) reported the European launch of the orthoPACE device intended for use in orthopedic, trauma and sports medicine indications following CE mark approval last month.

The orthoPACE incorporates the company's Pulsed Acoustic Cellular Expression (PACE) technology platform that delivers extracorporeal shock wave technology (ESWT) to treat a wide variety of chronic and acute conditions in hard and soft tissue. This device platform generates high energy, electrohydraulic shock waves that activate biological signaling and angiogenic responses, including revascularization and microcirculatory improvement, helping restore the body's normal healing processes and promote regeneration.

In the orthopedic setting, the orthoPACE will initially be used to treat tendinopathies and acute and nonunion fractures, including the soft tissue surrounding the fracture to accelerate healing and prevent secondary complications and their associated treatment costs. The system can also be used as an adjunctive treatment to fixation, fusion and grafting procedures.

Lantheus launches Definity in India

Lantheus Medical Imaging (North Billerica, Massachusetts) reported the launch of its ultrasound contrast imaging agent, Definity Vial For (Perflutren Lipid Microsphere) Injectable Suspension, in India.

The company said it has signed a multi-year agreement with J.B. Chemicals & Pharmaceuticals (Mumbai) for the distribution and marketing of Definity in the Indian marketplace. The launch expands Lantheus' presence in southern Asia. Definity is currently marketed in North America, Australia and New Zealand, parts of the Pacific Rim, and several countries in the Middle East.

Definity is an ultrasound contrast imaging agent that is indicated in India for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, as well as for use in patients in contrast-enhanced diagnostic ultrasound imaging to improve characterization of focal lesions of the liver and kidney.

IBA tapped for new Swedish proton therapy center

Skandion Clinic, the clinical center for proton therapy in Sweden, has selected Ion Beam Applications (IBA;Louvain-La-Neuve, Belgium) for the installation of a particle therapy facility. This new center will be managed by a consortium of seven Swedish counties, representing eight university hospitals.

Pending a comprehensive public tender and a detailed review of all the offers, Skandion has selected IBA for the supply and installation of a particle therapy facility, including the cyclotron, the equipment for two treatment rooms, the installation of a scanning beam nozzle for experimental purposes and other ancillary equipment. The contract also covers a five year service agreement and all non-clinical operations. This project amounts to between €40 and €50 million.

The contract award is, however, subject to an appeal process filed by Varian Medical Systems (Palo Alto, California) and Sumitomo Heavy Industries (Tokyo). Such a process can typically take four to six months.