A Medical Device Daily

Boston Scientific (Natick, Massachusetts), which has roughly 4,500 employees in Ireland, has reported plans to close its facility in Letterkenny, County Donegal, next year. About 120 people are employed at the site, which has been operating since 1992.

The company said that most of the manufacturing currently carried out at the Letterkenny plant would switch to its Galway facility. The decision to close the facility was made after a review of the U.S. firm's operations in Ireland.

Last August, Boston Scientific announced the closure of its Tullamore plant, with the loss of 240 jobs.

The company said opportunities would be made available for workers at Letterkenny to move to the Galway facility.

Boston Scientific, which recently acquired Labcoat Ltd., a small medical device development firm based in Galway, said it remained committed to its operations in Ireland.

In more positive Ireland life sciences news, Agilent Technologies (Santa Clara, California) and the National University of Ireland (NUI; Galway), reported the opening of a biological mass spectrometry facility on the NUI Galway campus.

The facility is equipped with the latest accurate-mass quadrupole time-of-flight (Q-TOF) and triple quadrupole (QQQ) mass spectrometer platforms from Agilent and is to focus primarily on functional genomics, proteomics, lipidomics and metabolomics research.

As part of the collaboration, NUI Galway will provide application notes and data for key applications using the Agilent Q-TOF and QQQ platforms. The facility also will be used to showcase new instruments to Agilent customers and to run samples for demonstration purposes.

Gustavo Salem, general manager for Agilent's LC/MS business, said,"NUI Galway has some of the top primary investigators in Europe. We look forward to working closely with them to further their breakthrough research in the fields of metabolomics and proteomics."

"NUI Galway has recently made a substantial commitment to increase its capability in mass spectrometry, in particular targeting life science research," said Professor Terry Smith, vice president for research at the university.

1st Belgian patient treated via RapidArc

A 74-year-old prostate cancer patient at the University Hospital of Leuven has become the first person in Belgium to be treated using the faster form of radiotherapy possible with the RapidArc technology from Varian Medical Systems (Palo Alto, California).

The patient, a retired military aircraft engineer, said he was pleased to be the country's first to receive this advanced form of image-guided intensity modulated radiotherapy (IMRT). His older brother also was treated for prostate cancer at the hospital two years ago, receiving a successful course of conventional IMRT.

Karin Haustermans, MD, head of the department of oncology at University Hospital, said,"We are identifying patients for whom RapidArc is a beneficial treatment and we have been very pleased with the early results. Not everyone will be treated in this way, but it appears to have major advantages in speed and precision for many of our prostate cancer patients."

Frank Van den Heuvel, director of physics, said he believes RapidArc will enable the hospital to bring standard treatment slots down from 12 minutes to 10 minutes, enabling six patients to be treated per hour rather than five."This is an entirely new technique for us, so early treatments will inevitably take a little longer, but once it becomes a part of our routine I believe we can achieve these targets," he said.

Prior to starting RapidArc treatments, research physicist Wouter Crijns carried out a series of tests revealing that RapidArc treatments could offer five significant benefits over and above conventional IMRT treatments. Along with time savings, RapidArc treatments generally show an improvement in sparing nearby organs at risk from being affected by the radiation, and patient comfort is improved because the time they need to lie on the treatment table is shortened.

University Hospital of Leuven treats up to 200 patients per day on five Varian Clinac linear accelerators. The hospital was one of the earliest in Europe to introduce IMRT treatments and the technique is now used routinely for prostate, head & neck, esophagus and rectal cancer treatments.

Enrollment completed in BST-CarGel trial

BioSyntech (Laval, Quebec) reported that it has completed enrolment for the Canadian-European pivotal trial of its cartilage repair device, BST-CarGel. The company said it achieved its planned objective of enrolling 80 patients into the randomized trial.

"We are grateful to the ... orthopedic surgeons who participated in this trial and were instrumental in achieving this milestone, despite the challenges presented by our strict eligibility criteria," said Michel Lagueux, BioSyntech chairman."With enrollment now complete, we look forward to the final results from this pivotal trial, which will be available in the first quarter of 2010 and will support marketing applications for BST-CarGel in Canada and Europe."

He added that the company is continuing to advance the investigational device exemption application process with the FDA for BST-CarGel.

The randomized trial compares the treatment of cartilage lesions using BST-CarGel applied following microfracture to treatment with microfracture alone. The trial enrolled subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm located on the femoral condyles of the knee. Subjects are further stratified by their lesion type, either characterized as acute (traumatic) or chronic (degenerative).

The primary endpoint for the trial is cartilage repair at 12 months, defined by the quantity and quality of the repaired tissue as measured with quantitative MRI. Secondary endpoints are safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire.