A Medical Device Daily

Eucomed (Brussels, Belgium), the European medical technology industry association, has named John Wilkinson as its new director general.

Wilkinson takes over operational leadership of the trade group from Maurice Wagner, who will leave Eucomed at the end of the month to pursue other opportunities after nearly six years heading the organization.

Wilkinson, who has more than 25 years of experience in the medical devices and diagnostics industry, joins Eucomed from the Association of British Healthcare Industries (ABHI), where he has acted as director general since the beginning of 2004. He will begin the transition from his current role to the Eucomed post next month.

Wilkinson said, “I am ... looking forward to working with staff and members on the very strong program that has been put in place at Eucomed by Maurice Wagner and the board of directors. With the challenges facing our industry it is essential that we work closely with policymakers both on a European and national level to continue to make a positive contribution to the European economy and to provide real benefits for patients.”

Guy Lebeau, MD, chairman of Eucomed, said that the Eucomed board “will work closely with Maurice Wagner during the next weeks to ensure a smooth transition toward the new leadership, both for our members and our stakeholders in Brussels and the EU member states.”

The association has identified as key strategic areas in 2008 that include “shaping the development of tomorrow’s healthcare systems, being an active partner with governmental bodies, and demonstrating the clinical benefit, value and cost-effectiveness of medical technology.”

Eucomed represents directly and indirectly 4,500 designers, manufacturers and suppliers of medical products, with small- and medium-sized companies making up more than 80% of the sector. The organization said the European medical-technology industry invests some EUR 3.8 billion in research and development and employs nearly 435,000.

Sorin in annuloplasty ring trial

The Sorin Group (Milan, Italy), Europe’s largest cardiovascular company, said it is supporting a clinical trial of the Sorin MEMO 3D annuloplasty ring for mitral valve repair. The purpose of the study is to evaluate the effectiveness and clinical outcomes of MEMO 3D when used to repair a diseased or dysfunctional mitral valve.

The open label, multi-site, treatment study will be recruiting patients and will be conducted at Penn Presbyterian Medical Center (Philadelphia) and several other North American sites. The primary outcome measure of the study will be the percentage of patients with successful repair at six months. Secondary outcome measures are: freedom from re-operation at 12 months; preoperative and postoperative mitral valve regurgitation, left ventricular dimensions and mass assessed by echocardiography; actuarial survival and freedom from clinical events at 12 months.

The lead principal investigator for the clinical trial is Dr. W. Clark Hargrove III, MD, clinical professor of surgery at the University of Pennsylvania School of Medicine and clinical director, division of cardiovascular surgery, Penn Presbyterian Medical Center.

“We are looking forward to learning more about how the device’s flexible capabilities will impact its efficacy in functional, ischemic, and degenerative mitral regurgitation (MR) as well as rheumatic procedures,” said Hargrove. “The device’s design makes it relatively easy to implant in place, and there is potential that it may be able to be used in many disease processes.”

Shortly after Sorin Group reported FDA clearance for the MEMO 3D in September 2007, Hargrove had successfully performed the first procedure at Penn Cardiac Care at Penn Presbyterian Medical Center, which is part of the University of Pennsylvania Health System (Philadelphia).

“The ring is expected to result in better physiological motion of the mitral annulus after mitral valve repair due to its flexible design and the Carbofilm coating of the ring,” Hargrove said at the time. “This results in decreased inflammatory response due to the introduction of a foreign body into the bloodstream.”

“We’re looking forward to this clinical evaluation further reinforcing the value and efficacy of this innovative device,” said Stefano Di Lullo, president of the Heart Valves Business Unit of the Sorin Group. “MEMO 3D has been specifically designed to maintain the normal physiological motion of the mitral annulus after mitral valve repair.”

Indicated for use in the repair of mitral heart valves, the MEMO 3D is distributed in the U.S. by CarboMedics (Lakewood, Colorado), a Sorin Group company.

Qiagen, U.S. center in collaboration

The Center for Molecular Medicine (CMM; Grand Rapids, Michigan) reported the formation of a collaborative effort between its affiliates and Qiagen (Venlo, the Netherlands) to support research focused on discovering molecular biomarkers capable of helping diagnose breast cancer and other women’s health issues.

Financial terms of the agreement were not disclosed.

The collaboration is centered on the CMM’s access to clinical samples, its molecular analysis capabilities and XenoBase software and database system developed at the Van Andel Research Institute (also Grand Rapids).

The specialized bio-informatic system is capable of analyzing a wide range of molecular and conventional clinical data to help researchers identify associations between diseases, biomarkers and treatments. It is the result of more than five years of work by Craig Webb, PhD and Jeremy Miller, PhD, of the Van Andel Institute.

Based on the result of Qiagen’s initial research, the U.S. center also may provide laboratory-based genomics and proteomics services to assist the Dutch firm in the development and validation of new molecular diagnostic tests.

CMM is a clinical diagnostics laboratory, founded in early 2007 as a joint venture between Grand Rapids-based Spectrum Health and the Van Andel Institute.

New Dublin office for Cerner

Cerner (Kansas City, Missouri), an international supplier of healthcare information technology solutions, has opened a new office in Dublin, Ireland, as it continues to expand its healthcare IT presence in that country.

After serving the Republic of Ireland via its London operations for the past three years, Cerner said the Dublin office serves to strengthen its relationships with key clients and enhance its software offerings for the European market by having translation and localization services in Ireland.