A Medical Device Daily

Cook Medical (Bloomington, Indiana) reported that it has received preliminary hospital reimbursement for endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) in Japan. The company’s Zenith AAA stent graft is the only device approved for sale in Japan for this type of procedure, it said.

Cook said it expects full reimbursement in Japan in March, receipt of which will launch a complete rollout of the Zenith stent graft system across the Asian country.

“Cook was first to the market with this life-saving medical device technology in August 2006 and in just four months we have hit another major milestone with this news of preliminary reimbursement,” said Barry Thomas, global leader of Cook’s Endovascular Therapies division. He said the company’s rapid progress in Japan is the result of a collaborative effort between Cook and its Japanese distributor, Medico’s Hirata.

A requirement of approval includes providing detailed clinical training to Japanese physicians to ensure their safe and effective use of the device. The device, which Cook said is the most widely used AAA endograft in the world, has a nine-year history of successful use in Europe and a seven-year history in the U.S., according to the company.

Prior to the development of endovascular treatment, patients diagnosed with a large, swelling abdominal aortic aneurysm that could rupture faced extensive open surgery requiring days of recovery time in the hospital and weeks of post-procedural recovery time before they could resume normal activities.

During endovascular repair, a physician makes two small incisions in the groin to insert catheters that are guided under fluoroscopy to the site of the aneurysm. Once in place, the catheters deploy a self-expanding endograft constructed of polyester surgical graft material supported by stainless steel Z-stent bodies.

Cook said the major benefits of the Zenith design for endovascular AAA repair include suprarenal fixation with anchoring barbs to ensure maximal stability and graft-to-vessel sealing, woven polyester graft material that is lightweight, strong and shrink-resistant, and the H&L-B One-Shot Introducer System that allows simple, accurate deployment and positioning of the graft.

Digital pathology solutions launched in India

BioImagene(Cupertino, California), an image informatics company, reported the launching of its Digital Pathology solutions for the Indian market at the 12^th International Continuing Medical Education in Surgical Pathology and Cytology conference in Pune, India.

The company said it is viewing the Indian market to expand its global outreach in the digital pathology market. Its product offering is a complete end-to-end solution that “will enable scientists and pathologists to implement a comprehensive scientific data/image management, processing and analysis solution where image data and metadata will be accessed, viewed and analyzed securely through a web browser.”

According to the company, the system’s flexibility would support remote consultations for projects focused on the cancer market.

BioImagene CEO Mohan Uttarwar said, “BioImagene would like to take digital pathology to a whole new level by making it easy and affordable for pathologists to manage, analyze, share, and report on their images with simple mouse clicks.”

The company said its digital pathology solutions will benefit pathologists by digitization of glass slides and their better visualization on a computer screen; simultaneous image access for more than one pathologist, easing peer review/second opinion processes with online sharing and collaboration of images; and image manipulation to assist in subspecialties such as immunohistochemistry and cytology, especially Pap smears.”

BioImagene develops image informatics solutions for digital pathology, life sciences research, and drug discovery and development, with a line of products from the firm’s flagship management platform known as 3i.

Canada okays Abbott assays, instrument

Abbott Molecular (Des Plaines, Illinois) and Celera (Rockville, Maryland) reported that Health Canada has approved the Abbott m2000 automated molecular diagnostic instrument and the Abbott RealTime HIV-1 and hepatitis C virus (HCV) viral load tests for marketing in Canada.

Abbott Molecular markets the m2000 system and a menu of tests throughout the world as part of a strategic alliance with Celera.

The Abbott RealTime HIV-1 and HCV assays are intended for in vitro diagnostic use as an indicator of disease prognosis and an aid in the management of patients undergoing antiviral therapy. They are not intended to be used as screening tests for HIV-1 or HCV, or as diagnostic tests to confirm the presence of HIV-1 or HCV infection.

Both tests have been developed for use on the Abbott m2000 system, an automated instrument intended to improve DNA and RNA testing in molecular laboratories. The m2000 system is based on real-time polymerase chain reaction (PCR) technology and is designed to accurately detect and measure life- threatening viruses and bacteria in patient serum or plasma samples in less than five hours, the company said, compared to other testing methods that may take up to two days.

“By automating all of the complex and heavily manual steps often associated with molecular testing, the m2000 system gives molecular laboratories the ability to prepare patient samples and deliver test results fast and efficiently,” said Edward Michael, president of Abbott Molecular. “It is expected to help physicians improve medical care through earlier intervention and the ongoing monitoring of a patient’s response to therapy.”

Celera is an Applera (Norwalk, Connecticut) business.

Grey adds majority interest in Spanish agency

Grey Healthcare Group (GHG; New York), a WPP company that is one of the world’s largest healthcare communications firms, said it has acquired a majority stake in Comunicacion y Servicio Consultores de Marketing Publicidad (CyS; Madrid, Spain), an independent healthcare communications services agency.

GHG said the acquisition of CyS deepens its European presence and adds an additional level of expertise to the company’s network of 43 offices in 22 countries.

Founded in 1997, CyS’s clients include Bristol-Myers Squibb, Pfizer, Abbott Laboratories, GlaxoSmithKline, Schering-Plough and Boehringer Ingelheim.

CyS will continue to be managed by General Manager Jose Antonio Alguacil.