A Medical Device Daily
CeloNova BioSciences (Newnan, Georgia) reported it has received approval from its European regulatory body, the British Standards Institution, to expand the list of medical indications for which Embozene Microspheres may be used and to add a tenth size of the product.
In Europe, Embozene Microspheres are now approved for the treatment of liver cancer, uterine fibroids, tumors of the head, neck, torso, and skeletal system; for bleeding and trauma, including nosebleeds; and for reducing the amount of bleeding before any surgery other than in the central nervous system. "Physicians throughout Europe, in Japan, the Middle East, and the United States have used Embozene Microspheres successfully to treat a variety of conditions. Physicians report that patients have less pain, speedy recovery, and are back to their regular activities sooner," said Thomas Gordy, president/CEO of CeloNova BioSciences. "With the addition of a 75 micron microsphere, CeloNova now has three distinct sizes of Embozene Microspheres for physicians to use in the smallest blood vessels. With ten sizes that range from 40 microns to 1300 microns, this product is the most versatile in the market."
SpectraScience, Bielderman in pact
SpectraScience, (San Diego) reported that it has engaged Bielderman BVBA, a contract research organization to manage the clinical process for its Barrett's esophageal cancer application under trial at certain European locations. The trial results will be used in the company's application to the FDA for use in the U.S.
Generally speaking, quality clinical studies are less expensive in Europe. Through its selection of Bielderman, SpectraScience is employing its strategy of obtaining international approval first and marketing its product in Europe while concurrently moving forward with an FDA submission for approval in the U.S.
SpectraScience holds nearly 60 patents worldwide that have been issued or are pending for its WavSTAT Optical Biopsy and Luma Cervical Imaging Systems. These non-invasive optical biopsy devices are used to diagnose tissue quickly to determine if it is normal, pre-cancerous, or cancerous within seconds. The WavSTAT and Luma systems are currently approved by the FDA for detecting pre-cancerous and cancerous tissue in the colon and cervix, respectively. As noted above, evaluation of the WavSTAT for detection of pre-cancers in the throat (Barrett's esophagus) is in process.
Varian, Brain lab to treat cancer in Latvia
Doctors in Latvia have begun treatments using the region's first Novalis Tx radiosurgery platform from Varian Medical Systems (Palo Alto, California) and BrainLab (Westchester, Illinois). Two prostate cancer patients have been treated using Varian's RapidArc radiotherapy technology at the Riga Eastern Clinical University Hospital.
The Novalis Tx radiosurgery platform together with RapidArc technology enabled the clinicians to treat prostates with image-guided, intensity modulated radiotherapy (IMRT) in about half the time typically needed for conventional IMRT. "Our new radiosurgical instrument enabled us to spare surrounding healthy organs while precisely targeting the tumor with a high dose," said Sergey Popov M.D., head of the hospital's radiotherapy department.
Popov said the Novalis Tx radiosurgery platform is the Baltic region's first machine for frameless intra-cranial stereotactic radiosurgery of brain lesions and he said that cranial treatments would begin this month.