A Medical Device Daily

The first patients have been enrolled in Abbott 's (Abbott Park, Illinois) ZoMaxx Europe clinical trial. All were treated with the ZoMaxx drug-eluting coronary stent system for their coronary artery disease.

Karl Hauptmann, MD, head of internal medicine in the department of cardiology at Hospital of the Merciful Brother (Trier, Germany), performed the first procedures.

The ZoMaxx system features application of a biologically inert coating called Pharmacoat (phosphorylcholine, or PC), intended to enable steady drug elution over time, and application of Abbott's immunosuppressant drug, zotarolimus, which has been studied for the reduction of vessel re-narrowing.

Phosphorylcholine is licensed to Abbott from Biocompatibles International (Singapore).

Abbott describes zotarolimus as “the only drug designed exclusively for use on drug-eluting stents.”

The system's TriMaxx stent platform is made of stainless steel and tantalum, which the company said is “designed to enable optimal visibility under X-ray, with extremely thin struts and an ultra-low crossing profile to facilitate ease of stent placement.”

The ZoMaxx Europe study is a single-arm trial that will evaluate the safety and performance of the ZoMaxx zotarolimus-eluting stent in patients with single- or two-vessel coronary artery disease.

Abbott said the trial, which will include about 900 patients at up to 60 sites throughout Europe, represents an “important step” toward broadening the complexity of patients treated with the ZoMaxx stent.

The primary endpoint of the trial is target lesion revascularization (TLR) at nine months.

Franz-Josef Neumann, MD, of Herz-Zentrum Bad Krozingen Hospital (Baden-Wurttemberg, Germany), principal investigator of ZoMaxx Europe, said, “Abbott's drug-eluting stent has unique characteristics, and we look forward to studying the ZoMaxx system in patients with coronary artery disease, including those suffering from multi-vessel disease.”

Abbott plans to seek approval to market ZoMaxx in Europe later this year.

New assay from Cepheid

Molecular diagnostics firm Cepheid (Sunnyvale, California) reported the European release of the Smart EBV (Epstein-Barr Virus) Assay for clinical diagnostic use on the SmartCycler System.

Smart EBV is intended for rapid detection and quantitation of EBV viral load. EBV infection is associated with development of post-transplant lymphoproliferative disorder (PTLD), a complication of bone marrow or solid-organ transplantation in which uncontrolled growth of lymphatic tissue can become life-threatening. EBV-related disease also is common in immunocompromised patients such as those with HIV/AIDS.

Dr. Jean-Marie Seigneurin, professor of virology at the University of Grenoble (Grenoble, France), said, “EBV quantification by real-time PCR [polymerase chain reaction] permits an early diagnosis in the course of disease, in order to initiate a treatment for reducing the risk of PTLD.”

Cepheid CEO John Bishop said Smart EBV is Cepheid's third clinical molecular diagnostic product with CE mark certification for introduction in Europe this year, following tests for Group B streptococcus and BCR-ABL, “and is the first in a planned series of products targeted for the management of immunocompromised patients.”

Agilent, Nonlinear in marketing accord

Nonlinear Dynamics (Newcastle Upon Tyne, UK), a provider of bioinformatics solutions, has signed a co-marketing agreement with Agilent Technologies (Palo Alto, California) to mutually promote and distribute integrated analysis solutions. The agreement is centered on synergies between the Agilent 2100 bioanalyzer “lab-on-a-chip” platform and Nonlinear's TL120 DM software.

Financial terms were not disclosed.

The first stage of the agreement will see technical development to automate the export of electropherogram data from Agilent's bioanalyzer via software for analysis with Nonlinear's TotalLab TL120 DM for varietal identification.

The companies said this collaborative solution will enable researchers to import DNA, RNA and protein sample data from the 2100 bioanalyzer for further relationship comparison, archiving and data mining within TL120 DM.