CD&Ds

Growth will be slashed by half for German med-tech in 2009 but will not stop, creeping up by 2% to 3%, according to Spectaris (Berlin), an industry association representing 160 companies in the medical technology sector.

"The industry will not quite escape from the financial crisis unscathed," said Spectaris CEO Sven Behrens, who added, "However, the effects will not be as serious as in other industries."

Behrens based his projections on a December survey of members, who were evenly divided over the question of whether they expected a serious decline in sales in the New Year.

Spectaris reports 2008 sales among its members, which account for almost 40% of German med-tech revenues, will finish up 5% at €18.2 billion ($24.6 billion), down dramatically from the 8% growth for the year that Spectaris initially anticipated.

The German med-tech industry, which exceeds the total sales of France, Spain and the UK combined, was running white-hot in 2007, reporting an 8.6% increase in sales for that year to €42 billion ($57 billion), according to Spectaris.

According to 72% of companies participating in the survey, med-tech employment will continue to increase, leading Spectaris to project growth of 4.6% to more than 99,000 employees among its members.

Germany has a pent-up demand for engineers that has been frustrated by national immigration policy.

Of the group's member companies, 85% do not expect the financial situation to have a huge impact on their business in the current year. Although somewhat more subdued about next year, they largely – by a ratio of almost two to one – said they do not anticipate serious sales declines in 2009.

Export sales are expected to decline in 2009, according to the Spectaris forecast, which points to a slackening demand from the U.S., which represents around 21% of total German exports.

Spectaris manufacturers generate more than 60% of sales from exports, and the fluctuations in the exchange rate between the euro and the dollar also will play a factor in the year's sales performance, according to the organization.

Behrens expressed optimism for med-tech manufacturers based on the bedrock assumption that a rapidly growing global population and democratic changes will sustain an increasing demand for products and services.

Software limits damage to the brain

Researchers and neurologists at the Hopital Pitié-Salpêtrière (Paris) have developed an intelligent assistant for reading conventional cranial images to predict the exposure to brain damage for a patient experiencing mini-strokes and then to guide pharmaceutic treatment to reduce the damage.

When an artery in the brain becomes blocked, such as with a transient ischemic attack, the blood supply changes can cause brief neurologic dysfunction that serve as a warning for an approaching stroke.

Using a conventional MRI scan, the neurologists at Pitié-Salpêtrière run the digital data through software called NeurInfarct to identify the ischemic penumbra surrounding the affected artery.

This penumbra is where pharmacologic interventions are most likely to be effective in limiting necrosis of ischemic but still viable cerebral tissue.

Significantly, NeurInfarct does not require the injection of a contrast agent to provide an analysis of the image rendered by MRI.

Strokes are the third-leading cause of death in France and the leading cause of handicaps such as paralysis, speech impediment and vision loss.

In a matter of minutes, NeurInfarct can analyze an MRI image identifying the movement of water molecules, which are greatly diminished at the point of an infarctus and slightly more present in the penumbra.

The resulting analysis assists neurologists in planning a treatment strategy.

NeurInfarct software has been tested on 100 patients and is the subject of an article published in the January issue of Radiology that concludes the software is "at least as good" as methods requiring a contrast agent.

The software was developed by the Laboratory for Cognitive Neuroscience and Cerebral Imaging of the Centre Nationale de Recherche Scientifique in cooperation with the neurology department at Pitié-Salpêtrière.

Panic attacks boost heart risk

Research published in the European Society of Cardiology's (ESC; Sophia Antipolis, France) European Heart Journal indicates that people who have been diagnosed with panic attacks or panic disorder have a greater risk of subsequently developing heart disease or suffering a heart attack than the normal population, with higher rates occurring in younger people.

The study found that people who were younger than 50 when first diagnosed had a significantly higher risk of subsequent myocardial infarctions (MI), but this was not the case in older people. It also found there was a significantly higher incidence of subsequent coronary heart disease (CHD) in people diagnosed with panic attacks/disorder at all ages, but this was more marked in the under 50s.

The research also showed that the risk of dying from CHD was actually reduced among people of all ages who had been diagnosed with panic attacks/disorder.

The study is the first to look at a large sample of the UK population of all ages (a total of 404,654 people) selected from a primary care population that the researchers said could be broadly generalized to other countries with a similar socio-demographic structure.

It also is the first study to identify that the higher risk of heart attacks with panic attacks/disorder is mainly in younger people (aged under 50 years), and that having a panic attacks/disorder diagnosis is associated with a lower risk of dying from heart conditions.

Dr. Kate Walters, a senior lecturer in primary care at University College London, who led the research, said, "Not much is known about the relationship between panic disorder and cardiac disease. The symptoms of panic attacks can closely mimic those of a heart attack or acute cardiac disease, and it seems that there may be a complex relationship between them."

She added, "Our findings have significant implications for clinicians. Panic attacks were associated with a significant increased risk of a subsequent diagnosis of CHD and acute MI in those ... younger than 50. This may be due to initial misdiagnosis of CHD as panic attacks, or a true underlying increased risk of CHD with panic attacks."

Walters said, "Clinicians should be vigilant for this possibility when diagnosing and treating people presenting with symptoms of panic."

She and her colleagues looked at primary care medical records for 57,615 adults diagnosed with panic attacks/disorder and 347,039 adults who did not have the condition. They found that those under 50 were more than a third as likely (38%) to have a heart attack and nearly half as likely (44%) to develop heart disease subsequently than people who had not been diagnosed with the condition. For people over 50, there was a slightly increased risk of heart disease (11%).

Japanese approval for Duct Occluder

AGA Medical (Plymouth, Minnesota) said it has received approval from the Japanese Ministry of Health, Labor and Welfare for its Amplatzer Duct Occluder (ADO). The ADO is a percutaneous, transcatheter occlusion device used for the non-surgical closure of patent ductus arteriosus (PDA), a common type of congenital heart defect that occurs when a blood vessel known as the ductus arteriosus fails to close after birth, as it normally should.

President/CEO John Barr said, "Our exclusive distribution partner, Japan Lifeline Co., will immediately apply for reimbursement and intends to launch the product to the market in the first half of 2009 following receipt of reimbursement." All medical devices in Japan must receive reimbursement approval prior to marketing of the product.

The ADO is AGA Medical's second device to receive approval in Japan. The company's Amplatzer Septal Occluder was approved in 2005 and launched in May 2006.

The ADO is intended for the closure of PDAs larger than 4 mm, which represent roughly 30% of total PDA defects. Shaped to achieve consistent, effective closure, the device is made of self-expanding nitinol mesh and is designed to be introduced in a minimally invasive fashion through a catheter.

The ADO features a retention "skirt," which allows the device to be positioned properly and remain in place at the entrance to the duct.

The Amplatzer Duct Occluder was granted the CE mark in Europe in February 1998 and FDA approval in May 2003.

A second-generation model – ADO II – has been granted CE-mark approval in Europe and can be delivered through even smaller catheters and is appropriate for both smaller ducts and ducts with different geometries. AGA has a clinical trial under way to support approval for the ADO II in the U.S.

Separately, AGA reported that a German appeals court has ruled in its favor in a patent infringement proceeding against Occlutech (Jena, Germany). The suit was brought by AGA in 2006 in Dusseldorf, Germany, seeking to enjoin Occlutech from infringing the German part of AGA's European patent (EP 0 808 138) and for resulting damages.

The company said the amount of damages and other remedies will be decided in enforcement proceedings in the near future.

Following the District Court's decision in July 2007, requiring destruction of the infringing product and the entry of an injunction, Occlutech appealed the ruling and introduced its Figulla N product, which it maintained was non-infringing.

AGA said the appeals court not only affirmed the findings of the District Court, but also found that the Figulla N occluder was not materially different from Occlutech's original product, and thus subject to the injunction and resulted in damages to the U.S. firm.

The appeals court further has declined Occlutech's request to stay the infringement proceedings in light of parallel invalidity proceedings pending at the Federal Patents Court.

"The positive ruling of the German appeals court confirms our rightful ownership of this technology and supports the original ruling that Occlutech's products are a clear infringement on our intellectual property," said John Barr, president/CEO of AGA Medical.

CE mark for CardioFit

BioControl Medical (Yehud, Israel) said that its CardioFit system has received CE-mark certification from KEMA, its Dutch notified body. CardioFit was approved for marketing in Europe based on the results of a recently completed pilot study.

Intended as a treatment for NYHA class II-III heart failure patients who have failed to achieve symptomatic improvement through standard evidence-based management, CardioFit works by applying electrical impulses to the vagus nerve. A sensing electrode in the right ventricle detects the patient's heart rate and is used to control nerve stimulation.

"This ... provides an important seal of quality for CardioFit and opens important markets," said CEO Dr. Ehud Cohen. "We are grateful to the physicians who worked with us in the clinical study and provided us with the opportunity to introduce this therapeutic technology to clinical practice."

BioControl develops advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results.

Australian clearance for Endo-PAT2000

Itamar Medical (Caesarea, Israel), a developer of noninvasive diagnostic systems using its Peripheral Arterial Tone (PAT) signal, said it has received Therapeutic Goods Administration clearance in Australia for the Endo-PAT2000.

Described as "the first simple, inexpensive, office-based diagnostic test for endothelial function," the Endo-PAT2000 is a noninvasive device that measures endothelial function, the earliest clinically detectable stage of cardiovascular disease, using biosensors mounted on patients' fingers that measure minute changes in vascular tone using Itamar's PAT Signal technology.

The company said the Endo-PAT2000 "adds an unparalleled dimension to the prevention of cardiovascular disease by enabling physicians to accurately measure endothelial function and modify patient management accordingly."

Saying the medical community "has long sought a cost-effective and reliable method to detect endothelial dysfunction," Itamar said the Endo-PAT2000 enhances the traditional clinical setting's diagnostic capabilities for endothelial dysfunction.

The Endo-PAT2000 can be used in any setting, from hospital bedside to outpatient clinic.

"Itamar Medical is proud to bring our innovative PAT Technology to the medically-advanced Australian market," said President/CEO Dov Rubin. "This is an important milestone for ... [our] penetration into the Asia Pacific markets."

Lorrence Platania, managing director of JLM Accutek Healthcare, the Endo-PAT2000 distributor in Australia, said, "This certification paves the way for patients in Australia to get tested with the Endo-PAT2000, providing them with a comprehensive picture of their endothelial cell function, a critical factor in cardiac health."

Brazilian trade show set for June

The 16th international Hospitalar trade fair will take place from June 2-5 at the Expo Center Norte in Sao Paulo, Brazil.

An expected 1,200 exhibitors from more than 30 countries will showcase their latest technologies and products to an anticipated 78,000 visitors from 70 countries.

The organizer of the event is Hospitalar Fair & Congresses, with the support of Messe Düsseldorf, the manager of MEDICA, the leading international medical trade fair worldwide.

Hospitalar is the largest medical trade fair in Latin America, and the 2009 version will feature a wide range of products and equipment for hospitals, clinics, laboratories, pharmacies and medical and dental offices.

A special feature will be the North American Pavilion for U.S. and Canadian exhibitors, organized by Messe Düsseldorf North America (Chicago). At the pavilion, companies will be provided with a fully equipped, turnkey booth which Messe Düsseldorf North America will custom design according to the exhibitor's specifications.

Messe Düsseldorf noted that the medical products industry in Brazil has grown over the last few years and international products continue to be very important for the Brazilian and Latin American healthcare sector overall.

The exhibits at Hospitalar 2009 will be supported by the 14th Latin America Congress of Healthcare Services as well as an extensive ancillary program consisting of 60 congresses, conferences and workshops.

Four thematically related trade fairs will be held concurrently with Hospitalar: OdontoBrasil (dentistry), Diagnostica (clinical analysis and pathology), Hospfarma (hospital pharmacies and drugstores) and Reabilitacao (assistive products).

Dates changed for China Med 2009

The 21st China Med International Medical Instruments and Equipment Exhibition will be held at the China International Exhibition Center in Beijing from March 19-21, 2009. That is a change from the originally announced dates of April 27-29.

The event will be jointly organized by Messe Düsseldorf China, China World Trade Center Co. Ltd., Hui Tong Xing Ye International Exhibition Co. Ltd. and the Health Department of the General Logistics Department of the Chinese People's Liberation Army.

China Med 2009 will have the support of Messe Düsseldorf, the organizer of the largest international medical trade fair, MEDICA, held annually in Düsseldorf, Germany.

The China Med exposition is expected to feature more than 500 exhibiting medical equipment companies in exhibit categories ranging from medical diagnostics and imaging equipment to surgical instruments and medical software, electro medical technology and hospital equipment and IT technology.

New additions next year will be the Medical Information and Application Pavilion, the Medical Consumables Pavilion, the Orthopedics Pavilion, the Dental Equipment Pavilion and the Rehabilitation and Physical Therapy Pavilion.

A wide range of seminars will support the exhibits.

At the China Med 2008 staging last spring, 537 exhibitors from 20 countries displayed their products to 25,560 visitors from 57 nations.

Asia MEDTECH to be rescheduled

Asia MEDTECH 2009, which had been scheduled to be held from March 25-28 in Singapore, along with Global-Asia Trade Exchange Medical Technology 2009, scheduled to take place on March 26-27, will be postponed to a later date, organizers said.

The events, organized by the Singapore Precision Engineering & Tooling Association, sought to promote engineering suppliers to the medical equipment and device manufacturing sectors in Singapore and Asia.

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