A Medical Device Daily

Rubicon Medical (Salt Lake City) said it has received the CE mark for its Rubicon Filter, an embolic protection system that traps and removes debris that may be dislodged during interventional procedures.

The product, which will be marketed and distributed in Europe by Boston Scientific (Natick, Massachusetts), has been cleared for commercialization in three indications – saphenous vein grafts (SVG), native coronary arteries and carotid arteries – as well as in three sizes: 4 mm, 5 mm and 6 mm filters.

To treat patients who have blood vessels partially or fully occluded with plaque buildup on the vessel walls, surgeons will often use a small wire mesh tube known as a stent to prop open the target vein or artery. When used in conjunction with a stenting procedure, the Rubicon Filter is maneuvered into place and deployed downstream from the blockage prior to the delivery and opening of the stent, with the goal of allowing surgeons to capture and remove dislodged plaque from the blood vessel during and after the stenting procedure. Studies have identified such dislodged plaque (or embolic material) as a potential cause of heart attacks, stroke, kidney failure and death.

Rubicon Medical conducted two parallel clinical trials in Europe – the RULE-SVG study RULE-Carotid study – in support of its CE mark filing.

“This is a big day for Rubicon Medical. We have been working diligently in preparation for this approval,” said Richard Linder, president and CEO. “The Rubicon Filter performed marvelously in both native and SVG procedures, as well as in carotid applications.”

Paul LaViolette, chief operating officer of Boston Scientific, called the Rubicon Filter “a potential paradigm-shifting technology due to its low profile and ease of use.”

The RULE-SVG study included 54 patients with either saphenous vein graft disease or coronary artery disease in the native coronary arteries, including a number of high-risk stenting procedures. Those procedures were performed at hospitals in Germany and Italy, with many of the studies conducted by Eberhard Grube, MD, chief of interventional cardiology at Heart Center Siegburg (Siegburg, Germany).

In the RULE-Carotid study, the Rubicon Filter was used in 60 procedures with patients suffering from significantly blocked carotid arteries, the main vessels in the neck, which feed blood directly to the brain. The procedures were performed at hospitals in Germany, with Joachim Schofer, MD, co-founder of the Center of Cardiology and Vascular Intervention (Hamburg, Germany), as the principal investigator.

First ThinPrep Imaging System in UK

Cytyc (Marlborough, Massachusetts) said Tuesday that it has placed the first ThinPrep Imaging System in the UK at The Doctors Laboratory (TDL; London). TDL is the largest clinical pathology service in the independent healthcare sector in the UK.

The TDL contract with Cytyc UK Ltd. is for a term of five years, and represents a potential of about 200,000 imaged ThinPrep Pap tests during that period.

The Doctors Laboratory’s pathology service provides a wide range of diagnostic tests for general practitioners, consultants, clinics, hospitals, speciality and screening companies, occupational health departments, insurers, pharmaceutical product trials and laboratories, as well as esoteric test referrals from Central London and throughout the UK.

TDL introduced the ThinPrep Pap test to its clientele in June 2000 and provides a rapid cervical cytology service to its customers by consistently reporting test results within 48 hours.

“We are pleased to be Cytyc’s first UK site to implement the ThinPrep Imaging System,” said David Byrne, CEO of The Doctors Laboratory. “This enables TDL to further improve [our] commitment to quality and speed of service in this key area of diagnostics.”

Colin Clelland, MD, consultant pathologist at TDL, said, “We have found the ThinPrep Imaging System to be a reliable and beneficial aid for rapid, accurate interpretation of ThinPrep cervical cytology. It has . . . improved workflow significantly.”

TDL became part of Sonic Healthcare, one of the world’s largest clinical pathology companies, three years ago. Sonic has laboratories in Australia, Germany, New Zealand and the UK.

French firm to distribute Mesomark test

Fujirebio Diagnostics (FDI; Malvern, Pennsylvania), an oncology testing leader, and Cisbio international, a French biotechnology company, reported a distribution agreement for European distribution of FDI’s new Mesomark blood test for mesothelioma.

This agreement, the second for FDI, continues the worldwide commercial rollout of Mesomark. FDI launched the test in Australia earlier this year.

Mesothelioma is a highly aggressive form of cancer in which fluid accumulates between the lining of the lungs and chest cavity. It is primarily caused by work-related asbestos exposure and has an average latency period of up to 75 years. It is estimated that 10,000 new cases are diagnosed each year among industrialized countries, and recent epidemiological studies predict an increase in that number in the next few decades.

Up until now, there have been no reliable serum tumor markers for mesothelioma, which means that diagnosis, screening and monitoring responses to treatment have been difficult. In addition, mesothelioma is notoriously resistant to chemotherapy and radiotherapy, and is rarely cured by radical surgery.

Mesomark, a manual enzyme-linked immunosorbent assay for managing mesothelioma, works by identifying a group of molecular markers called soluble mesothelin-related proteins, which are released into the bloodstream by mesothelioma cells.

Cisbio international, a wholly owned subsidiary of Schering SA, manufactures diagnostic assays for the quantification of tumor markers and other biomarkers in clinical biology.

Fujirebio Diagnostics specializes in the development of in vitro diagnostic products for the management of human disease states, with an emphasis in oncology.