A Medical Device Daily

The majority of the gene therapy trials approved by the UK’s Gene Therapy Advisory Committee (GTAC) last year – seven of the total of 11 – are focused on cancer. Of the other applications, one is an approach to combat HIV infection and three are for coronary heart disease.

According to the GTAC’s 11th annual report, covering 2004, trials have been approved for colorectal cancer, prostate cancer, leukemia, brain cancers (two studies), breast cancer and advanced tumors. That continues the trend of more than 70% of all applications to GTAC having a focus on cancer.

The report highlights the UK’s leading position on gene therapy trials in Europe, and also includes summaries of the completed gene therapy trials and an analysis of all the 96 UK trials carried out to date. It was published during the GTAC’s annual meeting, held at the University of Manchester earlier this month.

UK Health Minister Lord Warner saluted GTAC on its work, noting that “the UK leads Europe in this field, with 40% of European gene therapy clinical trials being carried out [here].”

Saying that gene therapy “has the potential to improve the lives of thousands of patients,” Warner said the UK government “is committed to ensuring that the UK remains at the forefront of innovative medical research and has provided the funding toward new gene therapy clinical trials for inherited diseases such as Duchenne muscular dystrophy, cystic fibrosis and childhood blindness.”

He said those trials are likely to be considered by GTAC in 2005-2006. GTAC is the national specialist ethics committee for gene therapy research. All UK gene therapy trials need approval from the committee.

Since approving the first gene therapy trial in the UK in 1993, GTAC has approved 96 such trials, involving almost 900 patients. Those gene studies target inherited disorders, infectious diseases such as HIV, and cardiovascular disease.

London site okayed for Cardima trial

Cardima (Fremont, California) has received approval from the regional ethics committee at Guy’s and St. Thomas Hospitals (London) to conduct a clinical study using the Revelation T-Flex and Revelation Helix catheters with the Intellitemp energy management system in the left atrium to create line of block lesions for the treatment of atrial fibrillation (AF).

The single-arm, non-randomized study, which is expected to involve 30 patients, will examine the clinical effect of creating a line of block lesions with radio frequency energy in the left atrium and pulmonary veins of the heart on patients suffering from AF, using the commercially available Cardima Revelation T-Flex and Revelation Helix catheter with the Intellitemp system. Under the approved trial design, the study also will evaluate the rate of recurrence and the rate of symptomatic AF episodes in these patients through six months following treatment.

Secondary objectives of the study will evaluate the length of procedure times, assessment of other procedural measurements such as the line of block placement and completeness of a line of block, and incidence of any device or procedural adverse effects.

Gabriel Vegh, Cardima chairman and CEO, said, “This European clinical study will be the first using Cardima’s entire system of the T-Flex, the Helix in conjunction with the Intellitemp in the left and right atrium,” said. “A well designed and documented clinical trial, showing good results, is an important step in marketing medical products. We expect this trial will further validate that the combined use of the T-Flex, Helix and Intellitemp as being safe and effective in treatment of AF and demonstrate reduced case procedure time, an important step in the ongoing development of viable treatment options for AF.”

The Revelation T-Flex has CE mark approval in Europe for the right atrium and incorporates eight coiled electrodes, eight tissue temperature-sensing elements and adds the ability to deflect – or steer – the catheter to the desired location.

Accenture buys Capgemini practice

Capgemini (Paris), a global consulting, technology and outsourcing services firm, reported the sale of its healthcare project and consulting practice in the U.S. and Canada to Accenture (New York) for $175 million. Effective upon closing of the transaction, about 600 Capgemini employees will transfer to Accenture.

The deal is part of a planned EUR 400 million assets disposal program reported by Capgemini last September. The company will retain its outsourcing contracts with healthcare clients in the U.S., as well as federal public sector health consulting capabilities in the U.S., both global strategic focus areas for Capgemini.

CEO Paul Hermelin said, “The fragmented, stand-alone nature of the U.S. private health provider market provided fewer synergies for the national public health care systems in Europe, where we continue to be a market leader around high-growth areas such as electronic health records.”

“We are strengthening our operations in North America by resizing and refocusing our project and consulting business as a result of this transaction, [we] will be in position to invest in key strategic areas,” said Pierre Danon, chief operating officer and executive chairman of North America for Capgemini.