A Diagnostics & Imaging Week
In what is described as a "groundbreaking" advance, French neurosurgeons have successfully treated brain tumors through ultra-keyhole surgery, using a tiny fiber-optic laser to destroy cancerous cells.
A report by the French news agency, AFP, quoted Alexandre Carpentier, MD, of Pitie-Salpetriere Hospital (Paris), as saying that the exploit was "a world first" in its use of multiple advanced techniques and of local anesthesia rather than general sedation.
Carpentier told AFP that thus far, eight volunteers have been treated in the pilot program, launched in December 2006.
"They were suffering from metastasing brain tumors caused by various cancers, mainly lung and breast cancer that failed to respond to conventional treatment and were otherwise inoperable," he said.
AFP's Brigitte Castelnau said in her story that doctors had given the patients involved only three months to live, on average. The pilot trial, reported in the latest issue of the journal Neurosurgery, was carried out under the supervision of the French Health Products Safety Agency.
It drew on technology supplied by the University of Texas M.D. Anderson Cancer Center in Houston, and a Texas company, BioTex (also Houston) which specializes in the use of lasers for medical therapy.
According to the AFP story, under the pioneering technique a tiny hole 3 mm (0.12") wide is drilled into the skull, allowing the surgeon to introduce a water-cooled fiber-optic laser into the brain. The device is guided toward the tumor area with the help of an MRI scanner.
Castelnau reported that every three seconds, a computer workstation calculates the temperature at the area being burned by the laser to ensure that there was no dangerous overheating and to confirm that only tumorous cells were being destroyed.
The patient received only a local anesthetic, remaining conscious in order to be able to speak to the medical team to help verify that cerebral functions were not being harmed.
However, "the patients feels nothing during the operation and generally can leave [the] hospital 14 hours later, the evening or the morning after the operation," Carpentier told AFP. The results are "conclusive," the surgeon said.
Treating the patients completely requires two or more bouts of surgery, and there have been no cases of cerebral bruising or epilepsy. Castelnau's report said that so far, six of the eight volunteers have completed the full program. Of the six, five have not had a relapse — a return of cancerous cells to the brain — at a nine-month monitoring point.
"This is the first time that laser technology has been used intracranially ... using MRI in real time to avoid collateral damage," Carpentier said. "This is the forerunner of future techniques in which MRI will play a core intervention role in neurosurgery."
Tepnel launches DNA test to detect early-stage FH
Tepnel Life Sciences (Manchester, UK/Stamford, Connecticut) reported the launch of a DNA test for the early detection of familial hypercholesterolemia (FH), a genetic condition that predisposes individuals to high blood cholesterol levels and increased risk of cardiovascular disease.
The CE-marked Elucigene FH20 kit, validated for in vitro diagnostic use, can rapidly determine the 20 genetic mutations most commonly found in a UK-based population, that are responsible for the disease.
The company said the launch comes just prior to the expected release of clinical practice guidelines on familial hypercholesterolemia by the UK's National Institute for Clinical Excellence (NICE).
Tepnel said FH is a public health problem throughout the world, with an estimated 10 million people affected, the majority of who will suffer an adverse coronary event before they are 65 years old.
A common genetic disorder, the potentially lethal condition occurs in one of 500 people in Europe and North America. In the UK, it is estimated that up to 110,000 people are affected with FH and 75% of these cases are undiagnosed.
The NICE consultation on a draft of guidelines for use by the National Health Service (NHS) in England and Wales is being finalized, with anticipated publication shortly. NICE is expected to recommend that all FH patients be offered a DNA test, with subsequent cascade screening to be performed where the mutation is identified in a patient.
Following the confirmation of mutation status of an FH patient using the Elucigene FH20 assay, the Tepnel test can be used to detect other previously undiagnosed family members with FH through cascade screening programs.
In a recent UK pilot study, the test identified a 52% mutation detection rate in a sample of 110 FH heterozygous patients. "The study findings validate Elucigene FH20 as a valuable component for future FH screening programs in the United Kingdom, providing a cost-efficient and simple method for confirming a person has inherited this deadly condition," said Tepnel CEO Ben Matzilevich. "For effective treatment, early identification of persons with FH is essential and FH20 offers the NHS the right tool at the right time to implement the new clinical practice guidelines."
The company said that pre-symptomatic identification of FH individuals "can ensure the health risks of high cholesterol are minimized through appropriate modifications to diet and lifestyle."
Zila adds to European distributor rolls
Zila (Phoenix) said it has selected Dentaid to be the exclusive distributor of ViziLite Plus with TBlue, Zila's oral cancer screening product, in Spain, France, Germany and Portugal.
The U.S. firm said Dentaid is the market leader among dental distributors in France and Spain, and has recently established a "significant presence" in the German market. Terms of the agreement were not disclosed.
ViziLite Plus with TBlue is now available to 55% of the residents of Western and Eastern European member countries of the European Union. Zila previously reported the selection of distributors for the product in the UK, Ireland, Greece and Cyprus.
The product is Zila's flagship product for the early detection of oral abnormalities that could lead to cancer. The company said it is the first and only adjunctive medical device cleared by the FDA for use in a population at increased risk for oral cancer.
"ViziLite Plus is a much-needed oral cancer screening product for the practitioners that we call on," said Enric Masdevall, president/CEO of Dentaid Europe. "ViziLite Plus is a proven technology and will be a valuable aid in screening for precancerous lesions and early stage cancers before they reach more severe stages."