A Medical Device Daily

Global orthopedics giant Zimmer Holdings (Warsaw, Indiana) reported plans to expand its global manufacturing network by adding a 100,000-square foot-plant in Shannon, Ireland.

“We are delighted to be adding a new Ireland facility to our global network,” said David Dvorak, Zimmer president/CEO. “We are constantly assessing our worldwide operations and logistics network to maximize efficiency and customer service, and this project is a result of that process. We are grateful for the cooperation and encouragement of the national and local officials in Shannon and look forward to establishing a facility that utilizes the tremendous skills and expertise of the workforce to produce high technology medical devices.”

Zimmer said it considered a number of sites before selecting Shannon, including its existing sites and other global locations. The company expects to invest between $70 million and $75 million over the next two years in its new facility in Shannon and plans to begin manufacturing operations there in late 2008.

Initial employment will be 25 to 50 employees, with total employment expected to be about 250 in five years. At start-up, the facility will produce knee replacement implants, although other products could be added in the future.

Shannon Development and Irish Development Agency officials provided incentives including tax rate adjustments and training grants, but Zimmer did not disclose actual amounts.

Irish Minister for Enterprise, Trade and Employment Micheal Martin said, “Zimmer’s decision to establish at Shannon Free Zone adds significantly to Ireland’s profile as a leading location for medical device companies in Europe. Zimmer can be confident of finding highly skilled professionals and infrastructure of international standards in this part of the country.”

German firm launches new ELISA assay

mtm laboratories (Heidelberg, Germany) reported the launch of the CE-marked Cervatec Assay and, at the same time, the results from a large prospective study demonstrating substantially superior sensitivity to the presence of disease over the Pap test alone. The Cervatec ELISA assay will initially be commercialized in Central Europe as an adjunct to the Pap test in screening of women aged 35 and younger.

mtm’s Cervatec assay is based on the quantitative detection of p16, a novel biomarker for a cellular protein which is up-regulated in the presence of cervical disease. As such p16 is a highly sensitive marker for the presence of cervical disease. The product is to be used in conjunction with the conventional Pap test for the detection of cervical cancer and its precursor lesions. A cervical sample is taken by the clinician and then sent to a clinical laboratory for processing. The presence of the biomarker p16 in lysed cervical specimens is quantitatively measured by a colorimetric sandwich ELISA which can be run manually or on automated ELISA platforms. Increased levels of the p16 biomarker indicate the presence of pre-cancerous and cancerous lesions of the cervix uteri in first-line screening.

In a prospective study involving more than 7.500 enrolled women aged 35 and below, results using Cervatec and Pap test were compared with biopsy-confirmed diagnoses. Cervatec alone provides for a 90% sensitivity in the detection of biopsy-confirmed, high-grade disease compared to a 39% sensitivity for the Pap test alone. In addition, the combined use of Cervatec with the Pap test is detecting the level of underlying disease anticipated in this population.

Ruediger Ridder, chief scientific officer of mtm, said, “We are pleased with our study outcome, further confirming the unique properties of our proprietary p16 biomarker. Pap tests have served us well for many years, but still many women with early disease are missed in screening. We have shown in this study that the combined sensitivity of Pap with Cervatec is more than twice as high than when using Pap alone.”

Bob Silverman, chief commercial officer, added, “The combination of our easy-to-use Cervatec assay with conventional Pap testing represents a major improvement in the screening for cervical cancer and its precursors. Cervatec will improve the certainty for gynecologists and patients that severe lesions, which might otherwise remain undetected by Pap testing alone, are detected early when treatment interventions can be most effective.”

KCI to do 3-year German wound care study

Kinetic Concepts (KCI; San Antonio) reported what it termed a “milestone” toward broadening homecare reimbursement in Germany for its V.A.C. Therapy System.

KCI said the German Ministry of Health has approved a maximum three-year study period, including paid placements, to assess the clinical and economic benefits of negative-pressure wound therapy for patients who can be transitioned out of the hospital for post-acute treatment or for patients whose treatment is initiated in the home.

The company said V.A.C. Therapy is “widely accepted” within the acute-care setting in Germany for the treatment of complex, hard-to-heal wounds.

The study program, which will be conducted on a randomized basis, will evaluate the effectiveness of negative-pressure wound therapy using an open-cell polymer foam dressing as the wound interface vs. the current standard of care. The dressing to be utilized in the study is proprietary to KCI’s V.A.C. Therapy System.

Selected patients will receive V.A.C. Therapy in the home, which will be reimbursed to KCI by German health insurance funds. The study calls for annual progress reports to the Ministry of Health beginning in February 2009.

Catherine Burzik, president/CEO of KCI, said, “The decision will allow physicians to treat patients in a lower-cost setting while maintaining improved patient outcomes.”

bioMérieux added to European stock index

bioMérieux (Marcy L’Etoile, France) has replaced Gyrus Group (Wokingham, UK) in the HealthShares European Medical Products and Devices Index.

Companies included in the HealthShares European Medical Products and Devices Index, administered by QED International Associates (New York), are headquartered in Europe, quoted on at least one European stock exchange and are engaged in the research, development, manufacturing, distribution and/or commercialization of medical devices and/or products for the treatment or amelioration of human disorders and diseases.