Kensey Nash (Exton, Pennsylvania) said it has received CE-mark approval for the third generation of its embolic protection technology, known as the TriActiv ProGuard System. It said it plans to launch the system in Europe for use in saphenous vein graft procedures by the end of 1Q06.

The TriActiv ProGuard System is designed to prevent material or debris dislodged during stent procedures from embolizing downstream and causing adverse coronary events such as a heart attack. The system includes three integrated features – an embolic protection balloon, and a combined active flush and extraction system to remove problematic debris from the target vessel.

The company said the TriActiv ProGuard System incorporates several important design enhancements to the TriActiv System platform, including Local Flush and eXtraction (LFX) technology, which allows the system to better address branched anatomy, along with a new, smaller 6F-compatible size, which it said is generally preferred by physicians, particularly in Europe.

“This is a very important product introduction for the European market,” said Joe Kaufmann, president and CEO. “The ProGuard design allows for greater utility of the system through its ability to be used in branched vessel situations and its highly desirable 6F compatibility. The flexibility of this product to be used in branched anatomy is a fundamental enhancement to the TriActiv product line.”

He said Kensey Nash now will “actively pursue” study of the platform’s utility in native coronary and leg and renal peripheral anatomies, as a complement to its ongoing study of the ProGuard system in the carotid anatomy.

“We are now significantly closer to our objective of offering our physician customers in Europe a complete line of first-class embolic protection products,” Kaufmann said.

The company’s TriActiv System is cleared for sale in the U.S. The second-generation TriActiv FX System is approved for sale in the European Union. Regulatory clearance for the TriActiv FX is pending in the U.S.

Dutch study finds many undiagnosed MIs

Dutch researchers who analyzed more than 4,000 men and women over 55 to see how many heart attacks went undiagnosed at the time they occurred, found that the figure was more than four in 10.

The results come from an analysis of a large proportion of the men and women involved in the Rotterdam Study, a prospective population study investigating chronic disabling diseases. A total of 5,148 participants with no evidence of prevalent myocardial infarction (MI) were enrolled from 1990 to 1993.

Their report was published in the Feb. 14 edition of European Heart Journal, the journal of the European Society of Cardiology (Sophia Antipolis, France). The authors, who are from the department of epidemiology and biostatistics at Erasmus Medical Center (Rotterdam, the Netherlands), say their findings suggest that the role of ECGs in existing cardiovascular prevention programs should be evaluated.

The patients assessed by the researchers underwent a baseline ECG and examination. Data from clinically recognized MIs (i.e., heart attacks that were formally diagnosed) over the years that followed were analyzed. The 4,187 of the total who had at least one repeat ECG during two rounds of follow-up assessment between 1993-96 and 1997-99, were analyzed for clinically unrecognized MI.

Senior author Dr. Jacqueline Witteman, associate professor of epidemiology, said, “Over our median follow-up time of more than six years, we found an incidence rate of nine heart attacks per 1,000 person-years. There were around 12 heart attacks per 1,000 person-years in men (8.4 recognized and 4.2 unrecognized) and around seven per 1,000 person-years in women (3.1 recognized and 3.6 unrecognized). Additionally, in men as well as in women, there was one sudden death per 1,000 person-years.”

Overall, she said, 43% of the total heart attacks had been clinically unrecognized – one-third of the male heart attacks and more than a half of the female heart attacks.

Witteman said that in each of the age bands between 55 and 80, men had a higher incidence of recognized MIs than women and a similar incidence of unrecognized MIs. This provided the evidence that heart attacks are less often recognized in women, she said, irrespective of characteristics that have previously been associated with MI.

Co-author Dr Eric Boersma, associate professor of clinical cardiovascular epidemiology, said that although the study was conducted in the Netherlands, the results were likely to be equally applicable to any other developed country.

He said that in most developed countries, cardiovascular prevention programs are installed, which aim to identify high-risk individuals on the basis of classical risk factors, including smoking and obesity, and co-conditions, such as diabetes mellitus. “Our findings indicate that these programs might be enriched with an ECG,” Boersma said.

NorDiag, Transgenomic in tech accord

NorDiag (Bergen, Norway) and Transgenomic (Omaha, Nebraska) reported entering into an exclusive license and supply agreement that the companies said would unite their technologies in the fight against colorectal and pancreatic cancer.

Transgenomic has granted NorDiag exclusive European commercial rights to use its WAVE System and associated consumables to perform molecular diagnostic testing for the detection of colorectal and pancreatic cancer from stool samples. NorDiag will pay a licensing fee and has committed to certain minimum annual purchases.

NorDiag uses the WAVE System in its Genefec test, which can detect mutations associated with early development of gastrointestinal cancers such as colorectal cancer, which is the second most common cause of cancer mortality. Early detection has been shown to “significantly improve” patients’ long-term survival prospects, the company said.

Christian Horn, NorDiag CEO, said, “The exclusive European license to Transgenomic’s proven technology, which has been adopted in medical centers and research institutions [in] more than 35 countries, will further strengthen NorDiag’s position as an emerging European leader in molecular diagnostic testing.”

Horn said that following its initial success in the Scandinavian market, NorDiag is preparing to introduce Genefec to additional European markets.

He added that the WAVE System “is an important component in the automation and standardization of Genefec testing.”

Transgenomic CEO Collin D’Silva, said NorDiag’s sample-preparation methods “are an excellent complement to our high-sensitivity mutation detection technology. We believe this test offers significant benefit to patients, and that the success of the WAVE System in this setting demonstrates its potential application in a variety of related areas.”

Transgenomic said that to date, more than 1,000 WAVE systems have been installed in over 30 countries around the world.

Positron in Chinese j-v

Positron emission tomography (PET) scanner manufacturer Positron (Houston) said it has received Chinese government approval for a joint venture with Neusoft Medical Systems (Shenyang, China).

The j-v business, known as Neusoft-Positron Medical Systems, was initiated in Shenyang in mid-January. The company will manufacture all of Positron’s PET and PET/CT (computed tomography) systems.

Neusoft Medical Systems was founded in 1998, originating from Neusoft Group, the largest software company in China. The company produces a wide range of diagnostic imaging products and has installed thousands of units worldwide.

Positron’s president, Joseph Oliverio, said the joint venture “immediately brings a number of key elements to Positron that will position [us] as a leader in the PET industry. The Neusoft relationship adds valuable software and hardware design development capabilities that will enable Positron to deliver state-of-the-art PET and PET/CT devices.”

He said the manufacturing savings realized through the new partnership “will dramatically lower our cost of goods, labor rates and component pricing, allowing Positron to be much more efficient and effective in the global marketplace.”

Positron’s PET systems are sold under the Posicam trade name for the diagnosis and treatment of patients in the areas of cardiology, oncology and neurology.

Sorenson moves into Chinese market

Sorenson Medical (Salt Lake City), a provider of pioneering portable ambulatory infusion pumps for pain management, has reported its expansion into the Chinese medical device market with the approval of the company’s ambIT PCA ambulatory infusion pump by the Chinese State Food and Drug Administration.

The company also said that it has selected South Asia Pharmamedic Ltd. (Hong Kong) as its distribution partner in China and Hong Kong.

The ambIT PCA pump is a lightweight, portable infusion device that enables patients to go about their normal lives as they receive pain treatment, while reducing the threat of side effects and addiction from drugs. ambIT pumps are about the size of a TV remote, are housed in a belt pack and run on two AA batteries.

Sorenson Medical said infusion such pain pumps also allow patients to remain mobile after surgery and to recover comfortably at home, avoiding the risk of hospital-acquired infections and prolonged hospitalization.

LeVoy Haight, chief operating officer, said, “We believe the performance and convenience of our products will make a positive contribution to the quality of healthcare throughout China.”

The device was required to pass safety testing by an independent Chinese testing laboratory, including review of submitted safety data regarding the pump’s history of performance. Sorenson Medical’s design and manufacturing systems had to demonstrate compliance with the ISO 13485 international quality system requirements for medical devices and the U.S. FDA’s Quality System Regulations.

The company said Pharmamedic has “one of the most comprehensive distribution networks within greater China for pharmaceuticals and medical devices.”

Michael Wong, CEO of South Asia Pharmamedic, said, “We believe our depth and breadth of distribution coverage will help to quickly establish the ambIT PCA as a category-leading device in this market.”

The Pharmamedic distribution network currently covers more than 500 hospitals in 60-plus cities across 17 provinces and four municipalities in China. Through relationships with wholesalers in second-level cities, Pharmamedic also is able to resell to other small municipalities and townships in the country are otherwise less accessible.

Given Imaging shows progress in Eastern Europe

Given Imaging’s (Yokneam, Israel) PillCam SB Capsule Endoscope, used to diagnose diseases of the small intestine, has been making global inroads. The novel programmed mini-video in a swallowable capsule is moving fast to become the diagnostic standard in this sector around the world.

The company reported last month that the Ministry of Health of the Czech Republic has issued a reimbursement policy for PillCam SB capsule endoscopy, in effect providing immediate reimbursement for about 7 million Czech citizens who are covered by the Vseobecna zdravotni pojistovna insurance company.

Given Imaging CFO Yuval Yanai said, “It’s hard to say how this decision will affect our revenue. The importance for us is the possibility of coverage by other insurance companies in the Czech Republic and elsewhere in Eastern Europe.” He added, “We’re working in every country in Eastern Europe, and each reimbursement by an insurer speeds up the pace, because each positive decision influences other countries and insurers.”

At present, 250 million of the 350 million people worldwide who can obtain reimbursement from their insurers for use of the PillCam are in the U.S., with the rest in Europe and the Far East.

Company President and CEO Gavriel Meron said the company hopes that U.S. insurers will begin offering reimbursement of its ESO PillCam for the esophagus this year or in early 2007.

Given Imaging has a market cap of $750 million. The company’s guidance predicts a profit of $4 million to $8 million on $84 million to $90 million in revenue.

CAD sets platform for European growth

CAD Sciences (White Plains, New York), which is focused on production of advanced CAD technology for MRI of the breast, prostate and other organs, reported the establishment of a core base of reference centers, research collaborators and key customer sites in Europe to serve as a platform for the company’s continued expansion into that market.

The company said the creation of such relationships is “a key initial benchmark in the development of that market” and will accelerate the placement of its fTP CAD system with European radiologists to complement a growing base of installations in the U.S.

CAD Sciences received CE-mark approval last August to market its products throughout the European Union.

The company said it has placed applications personnel to support key selling relationships, which include Vedisys (Griesheim, Germany), described by CAD Sciences as “a highly-recognized distributor of high-end radiology information systems. Vedisys Managing Director Jan Pollard said CAD Sciences’ products “provide an innovative extension of Vedisys’ product line and demonstrate our commitment to provide customers with high-value solutions in radiology.”

Citing the importance of the European market to the company, CAD Sciences President Andreas Muehler said, “European radiologists were early adopters of breast and prostate MRI, and consequently, many opinion leaders in those specialties reside in Europe.”

He added: “We believe a strong presence in Europe is central to the development of fTP technology as a standard tool for analysis of contrast-enhanced MRI images of cancer by radiologists around the world.”

The company said that it developed multiple beta testing sites and research collaborations with academic centers in Europe throughout 2005, including the University Clinic in Cologne, Germany); University Clinic in Essen, Germany; and the University Clinic in Vienna, Austria.

Noting that the prostate application was developed to a large extent at his institution, Dr. Thomas Helbich, associate professor of radiology at the University Clinic Vienna, said, “It is a great example of a fruitful collaboration between clinicians and industry.”

Medicsight plans Japanese clinical studies

Medicsight’s (London) majority owned Japanese subsidiary, Medicsight KK (Tokyo), said it plans to initiate eight clinical studies in that country, jointly sponsored by the Japan National Cancer Center. The company said those clinical studies represent “a major step forward” in its plans to determine the performance of its ColonCAD and LungCAD software for Japanese patient groups.

“Medicsight is committed to ensuring our software is compatible with Japanese populations and is easy for Japanese radiologists to utilize,” said David Sumner, Medicsight Asia CEO. “These studies will concentrate on showing how computer-aided detection (CAD) can benefit radiologists in interpreting time-consuming and difficult-to-read studies such as CT colonography and identifying lesions in the lung, such as nodules.”

Sumner said this is the first time that such a series has taken place in Japan, “and we believe that it will further drive the adoption of CAD as being essential when reading these types of study.”

Medicsight’s CAD tools are designed to be seamlessly integrated into either 3-D workstations or picture archiving and communications systgems to assist radiologists in the identification of lesions found in the lung and polyps found in the colon. The company said that by utilizing a “concurrent-read” approach, Medicsight CAD allows radiologists to review the original images simultaneously with regions of interest generated by CAD.

Medicsight ColonCAD is an image-analysis software tool designed to be used with CT colonography (virtual colonoscopy) to assist radiologists in detecting and measuring potential colorectal polyps. The company said the product has been developed using one of the world’s largest CT scan databases and is the first concurrent-read CAD software available for CT colonography.

Medicsight LungCAD is a medical imaging software tool designed to assist radiologists in the evaluation of pulmonary nodules on CT scans of the lung. The product, which also uses a concurrent-read approach, is intended to assist radiologists in detecting lesions in the lung, such as nodules, while providing information to the radiologist to assess patient images more effectively.

Health information initiative unveiled

A new initiative to broaden the exchange of information on health matters has been launched by the European Union in cooperation with the European Broadcasting Union (EBU).

Unveiled by European Health and Consumer Protection Commissioner Markos Kyprianou, the Health in Europe project is financed to the tune of EUR 1.4 million from the EU Public Health Program and managed by the EBU.

Also known at the European Health Information Platform, the multi-media initiative aims at creating a network of public broadcasters and other media across Europe, fostering the exchange of reports including television documentaries, radio broadcasts and press and Internet articles on health issues.

“There is a need for better and more widespread information about health issues in Europe,” said Kyprianou. “This partnership of TV and radio networks across Europe through the European Broadcasting Union will help keep citizens, and in particular patients and health professionals, informed on public health issues with a European dimension.”

The project already involves the main public service broadcasters in 10 European Countries: ARD in Germany, CT in the Czech Republic, France2 (France), RTBF in Belgium, YLE in Finland, TVP in Poland, ERT in Greece, RAI in Italy, ORF in Austria, Radio Prague in the Czech Republic, Radio Netherlands and Radio France International.

All the other members of the European Broadcasting Union have been invited to join in the program.

Health in Europe generally is based on an ongoing exchange of reports on health and medicine produced by TV broadcasters for their on-air magazine-type shows. Reports are offered free of rights to participating organizations.

It also is to involve:

  • A series of TV documentaries, produced by a consortium of public service broadcasters around Europe.
  • A series of radio documentaries.
  • A series of animations for publication on web sites of participating organizations.

All information will be available on the project web site, where participants in the project also will exchange information.

European broadcasters and associated media will be encouraged to create their own health magazines; to include health themes in existing “magazines” shows; and to report on breaking health stories in their current affairs and news programs.

Royal Hospitals, Philips in 15-year deal

The Royal Hospitals (Belfast, Northern Ireland) organization has signed a deal worth more than EUR 173 million with Royal Philips Electronics (Amsterdam, the Netherlands) to provide, maintain and replace medical equipment for monitoring, diagnosing and treating patients over the next 15 years.

William McKee, chief executive of Royal Hospitals, and Jouko Karvinen, CEO of Philips Medical Systems, discussed the contract, which will cover equipment in operating theaters, critical care and a new imaging center due to be ready for use in 2007.

“This is a significant milestone in the modernization of services at The Royal Hospitals,” said McKee. “It’s a good deal for us as service providers – and a good deal for patients, who can be assured that equipment vital to their diagnosis and treatment is future-proofed and patient-friendly.”

The Managed Equipment Service element of the contract will ensure that downtime due to equipment failure is minimized and that medical equipment will be replaced in line with agreed cycles based on Royal College clinical guidance and incorporating technological advances.

Karvinen said the equipment and services alliance “symbolizes the future changes in healthcare, as outsourcing and partner-sharing models will increase patient benefits.” The service officially begins in October.

Dutch medical center to use dbMotion platform

dbMotion (Ra’anana, Israel), a provider of data-sharing technology that helps facilitate regional health information organizations and networks, re-ported that Leiden University Medical Center (LUMC; Leiden, the Netherlands), one of the leading academic medical centers in that country, will utilize the dbMotion Solution as the platform for a newly-formed Health Information Network initially targeted at improving care for geriatric patients.

Ness Technologies (Tel Aviv, Israel) will serve as the prime contractor for the project. The agreement was reported at last month’s annual conference of the Healthcare Information and Management Systems Society (HIMSS; Chicago) in San Diego.

The dbMotion Solution is a web-based technology that gives participating healthcare organizations secure access to select components of patient medical files maintained at facilities that are otherwise unconnected or have no common technology through which to share data. This is accomplished by creating a virtual patient record that integrates relevant patient information, while allowing all source information to remain intact in the original system, location and format.

Data can be shared within and across organizations even if interoperability has not been achieved.

dbMotion noted that the Dutch government has a long-term goal of establishing a National Electronic Patient Dossier (EPD) that will make all relevant information from the different points of care available on demand to providers in every region of the country. To help further that goal, Leiden University Medical Center conducted a proof-of-concept exercise to test whether the dbMotion Solution could serve as the platform for facilitating a regional EPD.

The company said that at the conclusion of a process that included testing of the dbMotion Solution in a network of geriatric care providers, it was determined that the technology could integrate within the frameworks and channels that exist in the Netherlands for the exchange of patient information.

Dr. Gerard Blauw, head of the LUMC Geriatric Policlinics, said, “We found that dbMotion provides a complete solution for our current needs and will be able to support our future requirements over the coming years.”

Vitrolife acquires Swemed

Vitrolife (Kungsbacka, Sweden) reported that it has acquired Swemed (Gothenburg, Sweden), a manufacturer of medical device products for in vitro fertilization.

Vitrolife will pay about SEK 65.2 million ($8.62 million) consisting of 1.4 million newly issued shares and a cash sum of SEK 28.1 million ($3.72 million). A net debt of SEK 28.8 million ($3.81 million) also has been taken over by Vitrolife.

Swemed makes medical device instruments such as needles, pipettes and catheters for ovum and embryo treatment in connection with in vitro fertilization. The business, with 28 employees, complements Vitrolife’s business within the area of fertility, which focuses on nutrient solutions (media) for the treatment of human infertility.

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