A Medical Device Daily

The Klinikum Memmingen (Memmingen, Germany), a private radiotherapy institute in Bavaria, has begun treating cancer patients with what it calls a new, more precise form of radiotherapy using a linear accelerator and special On-Board Imager (OBI) accessory from Varian Medical Systems (Palo Alto, California).

The equipment is the first of its kind in clinical operation in Germany and is being used at the institute to treat breast, prostate and head/neck cancer patients with image-guided radiotherapy (IGRT).

The OBI makes it possible for clinicians to image and treat on a single machine that rotates around the patient to take X-ray images and deliver treatments from virtually any angle. Mounted on the medical linear accelerator, the OBI device produces high-resolution X-ray images of the tumor and tracks changes in tumor shape, size or position over a multi-week course of treatment. It also allows clinicians to track and adjust for tumor motion caused by the patient's breathing during treatment sessions.

The new imaging capability enables doctors to locate and target tumors more accurately during treatments.

"This is really important because it enables us to offer more precise radiotherapy," said Andreas Rhein, MD, senior therapist at the new institute, constructed last year. "It allows us to increase the dose, particularly for our prostate patients, because we are confident that we are hitting the target and minimizing the affect on surrounding healthy tissue."

The Klinikum Memmingen is offering the IGRT treatments in collaboration with nearby Klinikum Kaufbeuren, which has treated cancer patients on Varian linear accelerators for many years. Although the new Varian Clinac 2100 high-energy linear accelerator equipped with the OBI device has been located at the new center in Memmingen, much of the planning and preparation work is carried out at Kaufbeuren.

Varian said it has equipped about 3,000 radiotherapy centers around the world with treatment machines, accessories and software for the most advanced forms of radiotherapy and radiosurgery. The company had more than 400 installations of the OBI complete or in progress at the beginning of 2007.

Varian has European manufacturing and engineering centers in Baden, Switzerland; Crawley, UK; Haan, Germany; Helsinki, Finland; and Toulouse, France. Its headquarters for Europe, the Middle East, India and Africa is based in Zug, Switzerland.

1st CardioPass trial patient discharged

CardioTech International (Wilmington, Massachusetts) reported that the first patient in its European clinical trial of CardioPass, the company's synthetic coronary bypass graft, has been discharged from the medical center where the coronary bypass surgery was performed. This is the company's first human clinical trial for European regulatory approval of the graft.

Michael Adams, president/CEO of CardioTech, called the procedure "an important accomplishment — we are pleased that our trial patient was discharged from the hospital in a similar timeframe that it takes for ordinary coronary bypass procedures."

CardioTech said it would not comment on trial results until its European Notified Body makes its determination based on the clinical data on the approved 10-patient protocol, which calls for each patient to be followed up for 90 days after CardioPass has been implanted. This process is expected to take about nine months.

CardioPass is designed as an alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20% of all bypass procedures. CardioPass is made from ChronoFlex, the company's biodurable medical-grade polymer.

Once it is implanted, the graft is designed to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact. ChronoFlex has been formulated to be flexible, enabling CardioPass to pulse like a human vein would as it carries blood to the heart.

EDAP to distribute Stonebreaker system

EDAP TMS (Lyon, France) has signed a letter of intent with LMA Urology Suisse (Gland, Switzerland) to exclusively distribute the StoneBreaker system in LMA's French territory.

The handheld LMA Stonebreaker is a portable intra-corporeal contact lithotripter, intended to fragment stones in the urinary tract. The system complements lithotripsy procedures performed with extra-corporeal shockwave lithotripsy (ESWL) devices by targeting stones located in places that cannot be reached with an extracorporeal shockwave generator.

The system received CE-marking last June and has been validated by extensive clinical trials confirming the effectiveness of the cynetic intracorporeal lithotripsy technique, EDAP said.

Marc Oczachowski, COO of EDAP, said, "The addition of the StoneBreaker system to our range of lithotripsy devices clearly complements our ESWL portfolio, thus widening our scope on the lithotripsy market."

Paul Molloy, president of LMA, cited EDAP's market leadership in France, saying, "We are confident that the addition of our LMA StoneBreaker device to the EDAP portfolio is going to benefit both companies and bring a new standard of care to those suffering from stone disease."

EDAP is the developer of the Ablatherm system for high-intensity focused ultrasound treatment of localized prostate cancer. It also produces and commercializes medical equipment for treatment of urinary tract stones using ESWL.

EDAP also reported the launch of revenue-per-procedure (RPP) Ablatherm service at Villa Claudia (Rome) and two new sites in Barcelona, Spain, El Instituto Medico Tecnologico and Clinica Quiron.

European credit facility for Sigma-Aldrich

Sigma-Aldrich (St. Louis) said late last month that it has established a $200 million multi-currency senior revolving credit facility in Europe. The new facility will mature on March 13, 2014. The company said the facility will be used for general purposes, including any acquisitions, by its European operations.

Wells Fargo Bank and the Bank of Tokyo-Mitsubishi UFJ were co-lead arrangers and joint bookrunners for the seven-bank syndicate participating in the facility.

Sigma-Aldrich's biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, disease diagnosis and as key components in pharmaceutical and other high-tech manufacturing.

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