A Medical Device Daily

The laboratory remains the primary site of hematology tests in Europe due to confidence in established methods of diagnosis, Frost & Sullivan (F&S; London) says in a new report. But it goes on to say that the rising awareness of the benefits of point-of-care-based (POC) hematology diagnostics will boost uptake in that competing sector.

A new report from F&S, “European Hematology Diagnostics Market,” finds that the market had revenues of $698.8 million in 2006, expected to reach $943.4 million in 2013.

“The expansion of the POC hemoglobin market is inhibited by the preference for laboratory-based tests, [but] there are several factors that ensure that the hematology market continues to grow,” says F&S Research Analyst Gayathry Ramachandran.

Key market participants are developing automated analyzers that will enable laboratories to accelerate throughput. Therefore, the trend in this mature market is projected to be toward the laboratory segment, with laboratories making the most significant contribution to overall market revenues.

Innovative technologies are supporting the continued expansion of the market. An aging population is also creating demand for hematology tests, with the urge to remain healthy motivating older citizens to undergo regular health checkups.

POC tests are slowly being preferred in some regions of Europe, as they generate quick results and assist physicians in identifying optimal treatments. Together, these trends are reinforcing overall market growth.

However, F&S said the reliance of physicians on tried-and-tested hematology tests is restricting the use of new test markers. Another challenge relates to the loyalty of laboratories toward particular manufacturers, which posed a significant for market entrants.

“The centralization of laboratories in Europe is minimizing revenue growth,” said Ramachandran. “The end-user base is very narrow – hospitals are the primary site for laboratory analyzers, while emergency units and intensive care units are the principal end-users of POC hematology analyzers – thereby restricting market growth.”

F&S said automation of analyzers will help reduce labor costs and sustain market expansion.

Newest Stereotaxis install in France

Stereotaxis (St. Louis) reported the placement of a Stereotaxis Magnetic Navigation System in France at a new electrophysiology lab at the University Hospital of Bordeaux.

The company said the EP lab is headed by Professors Michel Haissaguerre and Pierre Jais, whose discovery of the ectopic foci that trigger atrial fibrillation (AF) in 1998 “paved the way for new ablation techniques for more effectively treating the disease,” which affects millions of people worldwide.

“We are very enthusiastic about the present and future applications for the Stereotaxis system, which represents an engineering tour de force,” Haissaguerre said during the opening ceremonies for the new lab. “The Stereotaxis system allows stable and precise catheter positioning, potentially better than manual manipulation. Our initial experience on AF using the magnetic irrigated catheter is very promising, suggesting ... the potential for a higher safety margin in comparison with conventional manipulation while maintaining at least equivalent efficacy.”

He added: “Our next goal is to achieve complete automation of the many different techniques necessary for catheter ablation of cardiac arrhythmias and particularly AF.”

Bevil Hogg, CEO of Stereotaxis, said the installation of the Stereotaxis Niobe system in Bordeaux represents “a significant milestone for us.” He called University Hospital of Bordeaux “one of the leading research institutions in the world for electrophysiology.”

He noted that the installation includes an Odyssey Network Solution, a networked user interface that consolidates the multiple information sources and systems of a traditional EP lab into one large screen with single mouse control. That system, Hogg said, “has the potential to contribute significantly to procedure room simplification and work-flow productivity, and through its private network, to promote the dissemination of best practices worldwide.”

Saying that the irrigated catheter has now expanded to multiple sites in Europe, he said a “significant number” of cases using the irrigated catheter have now been performed, “and we are gratified to note the high success rate in terms of outcomes and patient safety.”

Noting that Haissaguerre and his team “are pioneers in the discovery of new approaches to the treatment of AF,” Hogg said, Stereotaxis looks forward to “using our collaboration with the Bordeaux team to advance scientific understanding and treatment of cardiac arrhythmias.”

Live Tissue Connect receives CE mark

CSMG Technologies (Corpus Christi, Texas) said the company’s Live Tissue Connect (LTC) subsidiary has received CE-mark certification for its new VAD-400 RF Generator.

“This is a major step toward launching the entire VAD-400 handpiece and generator system into the European markets,” said President/CEO Donald Robbins. “We are evaluating multiple distribution options, both in the U.S. and internationally.”

LTC’s Frank D’Amelio added that the company’s next step will be to obtain a CE mark for its disposable handpieces. “We know that there is a huge market in Europe for our generator and the instruments it will support,” he said. “Passing the CE-mark examination is a major requirement to address this market.”

Robbins said LTC “is attracting interest from many significant medical device companies and distributors interested in representing, licensing, and/or marketing some aspect of the LTC technology.”

LTC has identified 12 procedure-specific divisions and established the first six regarded as closest to product and market completion. CSMG said the subsidiary structure allows the company to leverage LTC’s research and development across multiple medical disciplines.

As an example, the company said the R&D effort that went into developing a sealing device for gynecological arteries and veins might be leveraged into a similar device for urological procedures, “although would likely be different in shape and/or size. This structure also lets potential marketing partners select surgical specialties where they have strong physician relationships and/or pre-existing distribution channels.”

LTC’s surgical tissue bonding/welding device is a platform technology that bonds and reconnects human soft tissue through fusion, in contrast with conventional wound closing devices such as sutures, staples, sealant, or glues.

The company holds a total of about 40 patents in the U.S., Australia, Canada, the European Union, Ukraine and other countries.