Diagnostics & Imaging Week
A U.S. federal court has denied an injunction filed by Siemens Medical Solutions (Malvern, Pennsylvania) to stop Saint-Gobain Ceramics & Plastics (Courbevoie, France) from marketing and distributing advanced crystals that are a key competitive advantage for Siemens’ top-of-the-line diagnostic imaging systems.
Siemens sued Saint-Gobain in April 2007 for infringement of a 1990 patent it holds on lutetium oxyorthosilicate (LSO) crystals that are an essential detector used for its 3D positron-emission tomography (PET) technology that is at the heart of the Biograph and Excel imaging systems.
A federal judge in Wilmington, Delaware, wrote on Jan. 8 that “Although plaintiff adduced evidence that ultimately may demonstrate infringement,” the case at this stage “does not weigh predominantly in plaintiff’s favor,” according to a Bloomberg report.
A Saint-Gobain spokesman said the company is “pleased” with the decision but declined to comment further, Bloomberg said.
A Siemens spokesman told Health Imaging News that it “is vigorously pursuing its lawsuit and looks forward to the jury trial in September.”
At the center of the dispute is the Saint-Gobain PreLude 420, an LSO crystal that Siemens claims is equivalent in its ability to give scanning arrays a faster throughput rates than competing technologies and thereby enable high-speed full body PET scans.
Higher patient processing counts for Siemens Biograph machines are a key selling point for the $3 million units. Siemens promotes its Biograph TruePoint scanners as three times faster than competing lines and the company claims a record 11 patients were scanned in one day at the Northern California PET Imaging Center with an average scan time of 35 minutes.
Improvements in crystals used for reading radiation have been a driver in the PET scanner market as the industry responds to greater demand. LSO crystals have a faster scintillation decay time and a higher percentage of relative light output than the more commonly installed bismuth germanium oxide crystals in units sold, for example, by GE Healthcare (Waukesha, Wisconsin) in its Discovery scanners.
Saint-Gobain Ceramics & Plastics is part of the $52 billion Saint-Gobain group, one of the top 100 industrial companies in the world. The LSO crystal arrays used in the company’s scintillation products sold for medical imaging are manufactured in Newbury, Ohio, Nemours France, and Soest, the Netherlands.
Saint-Gobain Crystals is said to be the world’s largest producer of detectors for nuclear medicine gamma camera imaging systems and produced scintillation detectors for the Lunar Prospector and MARS Odyssey probes.
Dune reports MarginProbe progress
Dune Medical Devices (Caesarea, Israel) has reported what it termed “significant new clinical developments” surrounding its newly trade-named MarginProbe breast cancer assessment probe, currently in investigational use.
The MarginProbe consists of a sterile, hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and are reflected back to the console, where they are analyzed using a specialized algorithm to determine tissue status.
The company said results from a recent randomized clinical trial conducted at 11 medical centers in Israel “have underscored the safety and clinical benefit of the system in the intraoperative detection of tumors at the resection margins (positive margins) in specimens of patients undergoing breast-conserving surgery.”
The study compared the performance of 35 surgeons operating on patients with and without the MarginProbe. Dune Medical said use of the system “resulted in a significant reduction in repeat surgeries, which are typically performed in order to surgically correct positive margins found following a patient’s initial lumpectomy.”
The company said the effect of the MarginProbe is “especially pronounced in patients with non-palpable lesions.”
Preliminary results for more than 110 patients with non-palpable lesions showed a 60% reduction in repeat surgeries in the study arm that allowed use of the MarginProbe. Dune said these results reflect initial data from the first 200 patients recruited and analyzed in the study.
Final results from the entire 300-patient cohort are slated for presentation at the annual meeting of the American Society of Breast Surgeons (Columbia, Maryland) in New York in May.
Dr. Dan Hashimshony, founder and CEO of Dune, said, “The new data ... suggests that the MarginProbe facilitates equally safe yet more accurate surgeries and will enable completing the surgical management of breast cancer patients with fewer repeated surgeries.”
Dune also reported the opening of a New Jersey office to spearhead North American activities.
Belgian fund buying Israeli retrofitter
The private investment fund Quaeroq (Waregem, Belgium) has taken a 10% stake in the CMT Medical Technologies (Yokneam, Israel) and said it plans to continue investing, although it denied it seeks a takeover. For the moment Quaeroq said it will seek a seat on the CMT board of directors.
The core business of CMT Medical is radiographic and fluoroscopic imaging systems, angiography, digital radiography and cardiac imaging. The company’s SmartRAD family of products have both FDA clearance and the CE mark, and are offered both as a retrofit system for existing hospital X-ray systems or as a digital subsystem for original equipment manufacturers.
SmartRAD is designed to be compatible with existing general radiology clinics which retrofit a flat-panel detector as an alternative to traditional film screen and computed radiography. The updated system increases patient throughput by more than 30%, while reducing exposure to radiation both for patients and operators.
Almost two-thirds of sales are from the Far East, with North America accounting for another fourth. Europe makes up 7% of sales.