A Diagnostics & Imaging Week

TomTec Imaging Systems (Munich, Germany) has introduced its new 4-D MV-Assessment software, which the company said combines the strength of 2-D with the advantages of 3-D echocardiography to provide doctors with “important and partly unprecedented diagnostic information for the mitral valve.”

Citing a growing trend to operate even on asymptomatic patients suffering from mitral regurgitation, the company said that increases the pressure on clinicians for precise diagnoses. Since only patients where the mitral valve can be repaired will benefit from early intervention, a pre-operative assessment of the feasibility of mitral valve repair becomes more and more important.

Tom-Tec said conventional 2-D ultrasound is limited in its ability to determine underlying mitral valve pathologies precisely, because the user has to reconstruct the complex 3-D anatomy of the valve mentally.

“Using 3-D echocardiographic datasets, 4-D MV-Assessment presents the anatomical structures of the mitral valve annulus and the closure line of the two leaflets in three dimensions,” the company said in a statement. “This simplifies assessing valve morphology and delivers accurate localization and size information for pathological findings that would be hard to make with conventional echocardiography.”

It said the findings from the 4-D MV-Assessment software “also contribute to better communication between clinicians of different specialities or with different levels of experience in ultrasound diagnostics ... [simplifying] the interdisciplinary planning of therapy.”

Frank Schlau, senior vice president of sales & marketing, said, “4-D MV-Assessment is the first dedicated 3-D clinical application for the mitral valve on the market. The easy and quick workflow makes the software applicable in the doctors daily clinical routine.”

TomTec’s product line encompasses a wide range of 2-D and 3-D/4-D technology for acquisition, analysis and reconstruction of ultrasound data. Its products are applicable to adult and paediatric cardiology, as well as obstetrics and gynecology, radiology and vascular diagnostics.

DOBI formulates China strategy

DOBI Medical International (Mahwah, New Jersey) said it has developed a multi-faceted business strategy for China designed to increase the acceptance of its Dynamic Optical Breast Imaging (DOBI) product, the ComfortScan system, in the Far East.

As part of that strategy, the company said it recently signed a distribution agreement with the China Center for Pharmaceutical International Exchange (CCPIE). Under the agreement, CCPIE will work with DOBI and the Chinese State Food and Drug Administration (SFDA) to oversee all the elements of the product approval cycle required by the regulatory agency.

“This new agreement marks our continued expansion into the very significant Asian marketplace,” said Robert Ellis, DOBI’s vice president of marketing, sales and service.

He said that statistics in China alone “prove there is a great need for the benefits that we believe are inherent in a health exam utilizing our ComfortScan technology.”

Ellis said the company expects that the local market expertise offered by CCPIE “will enhance our ability to commercialize in China with more ease and speed.”

The first step in the approval cycle was to conduct a technical review of DOBI Medical’s ComfortScan system. After successful completion, a clinical investigation certificate was awarded late last month.

The next step is a multi-site clinical study in which CCPIE will assist in the management and support of the sites involved with the trial. After the recent arrival of two ComfortScan systems, the study commenced at two sites in Beijing. When the study data have been gathered, CCPIE will centralize and compile the research results and submit final documentation to the SFDA for its review.

DOBI Medical has hired G. John Zhang, PhD, as area business manager, Asia/Pacific, to oversee activity in that region. Zhang, a native of China and a graduate of the Massachusetts Institute of Technology (Cambridge, Massachusetts), is experienced in the area of Chinese business development and left Boston Instruments to join DOBI.

Zhang said China has both the population and the intense need for the ComfortScan system, adding: “We expect the Asia/Pacific region to be a significant market for sales following the successful completion of our SFDA scientific and clinical review.”

According to the Chinese Anti-Cancer Association, more than 300 million women are at risk for breast cancer in China, making it one of the most common cancers among women in the country. The death rate from breast cancer has increased by 3% annually in recent years, making it the biggest killer of Chinese women.

As part of its expanded push in China, DOBI exhibited the ComfortScan system at the 10th China International Pharmaceutical Exhibition, held in Shanghai’s New International Expo Center last week.

DOBI Medical’s global distribution network now has 12 international distributors representing 16 countries – including India, Russia, Canada, Panama, Costa Rica, Colombia, Nicaragua, Brazil, the Czech Republic, Greece, Italy, Portugal, Switzerland, Liechtenstein and the Netherlands.

Dade launches homocysteine for BN systems

Dade Behring (Deerfield, Illinois), a leader in cardiac diagnostic testing, last week reported launching the homocysteine assay in Europe for use on its BN II and BN ProSpec diagnostic systems.

Homocysteine is a cardiac marker used to determine if a person is at high risk of a heart attack or stroke. When increased, it is found to be associated with the progression of vascular disease. The company said studies have shown that up to 47% of patients with symptoms of cardiovascular disease show elevated levels of the amino acid.

Dade Behring said the addition of the homocysteine assay allows the company to provide physicians with one of the most complete cardiovascular risk assessment menus, allowing them to better diagnose a patient at risk of a heart attack.

“Because heart attacks are the leading cause of death in both men and women, providing physicians with a better way to assess the health of their at-risk patients is a major priority for us,” said Jim Reid-Anderson, chairman, president and CEO of Dade Behring.

The homocysteine test may be run in a panel in conjunction with Dade Behring’s CardioPhase hsCRP, cholesterol, lipids, Apo A1/Apo B, Lp(a) and microalbuminuria tests. The company said this risk-assessment panel is run in both regular and specialized diagnostic labs.

Dade Behring co-developed the homocysteine test kit through an agreement with Axis-Shield (Dundee, Scotland), a maker of in vitro diagnostic kits in cardiovascular, rheumatoid, infectious and alcohol-related diseases, together with diabetes. Axis-Shield has a special focus on near-patient testing. Dade Behring will sell and distribute the product under the Dade Behring name.

Dade Behring offers a broad line of tests to help diagnose acute myocardial infarction and pulmonary embolism, and also to screen for heart disease risk. CardioPhase hsCRP was the first hsCRP assay to have a cardiac-specific claim as an independent marker for risk assessment and risk stratification.