• Agendia (Amsterdam, the Netherlands) said it has made its breast cancer prognosis test, MammaPrint, available to U.S. patients after receiving two clearances from the FDA. In February the agency cleared MammaPrint as an in vitro diagnostic multivariate index assay for use in breast cancer prognosis. In June, Agendia received a second clearance for the test in conjunction with RNARetain, an RNA stabilizing solution allowing shipping of tumor biopsies at ambient temperature, greatly facilitating the logistical process of sample handling. MammaPrint is a DNA micro array-based in vitro diagnostic laboratory service that measures the activity of 70 genes, providing information about the likelihood of tumor recurrence.
  • Sangart (San Diego), a biopharmaceutical company focused on the development of oxygen transport agents, said an independent data safety monitoring board (DSMB) has recommended the continuation of both Phase III clinical trials of Sangart's blood substitute product, Hemospan, under current protocols. This recommendation follows the DSMB's review of the blinded data from the first one-third of the 830 patients to be enrolled in two ongoing Phase III pivotal studies in Europe. The DSMB will conduct another review after two-thirds of the patients have been enrolled. Hemospan is a hemoglobin-based oxygen transport agent designed to serve as an oxygen therapeutic and as an alternative to blood transfusions. Sangart says a "key property of Hemospan is its high oxygen affinity which results in targeted oxygen delivery to tissues at risk of oxygen deprivation."
  • Simbionix (Cleveland) reported 10 new validation studies published during 2007 on the Simbionix Mentor series of training simulators, bringing the total number of studies published to 65. The studies include two new studies on the GI Mentor, two on the URO/PERC platform, three on the LAP Mentor and three on the ANGIO Mentor. The institutes which conducted studies include the University of Texas, Catharina Hospital of the Netherlands, the British Imperial College of London and the Graduate School of Medical Sciences in the Kyushu University of Fukuoka, the first study by a Japanese institute to date. The study carried out at Catharina Hospital's Department of Gastroenterology concluded that the GI Mentor II simulator offered a convincing, realistic representation of colonoscopy that can discriminate between different levels of colonoscopy expertise. As a result, the product was granted both construct validity and expert validity. The study carried out by Kyushu University of Fukuoka concluded that the LAP Mentor was able to differentiate between subjects with different laparoscopic experience. Simbionix said that one of the key "value points" for medical institutions to use Simbionix products is the ability to offer clinicians and medical students the required hands-on surgical experience at zero patient risk.
  • FlowCardia (Sunnyvale, California) reported FDA 510(k) clearance and immediate U.S. launch of the Crosser 14P, Crosser 14S and Crosser 18 CTO recanalization catheters. The three peripheral Crosser catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross chronic total occlusions (CTOs) to help restore blood flow to the lower legs. The Crosser is a rapid-exchange catheter delivered over standard .014" and .018" guidewires that uses high-frequency vibration to cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. The peripheral Crosser catheters were studied in the FlowCardia PATRIOT Trial.
  • Synthetic Blood International (Costa Mesa, California) said it plans to finalize a Phase IIb clinical trial protocol with Oxycyte for the treatment of traumatic brain injury (TBI) at its scientific advisory board meeting. Oxycyte is Synthetic Blood's perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute. The proposed double blind, placebo-controlled Phase IIb trial is designed to compare Oxycyte with present-day advanced therapies in TBI, and is expected to enroll 120 to 150 patients at six major neurosurgery centers. The trial protocol was prepared by M. Ross Bullock, MD, PhD, of the Miller School of Medicine of the University of Miami (Coral Gables, Florida). Bullock was a principal investigator on Synthetic Blood's Phase IIa pilot study with Oxycyte in TBI and serves on the scientific advisory board. The company's board said it plans to develop a strategy for initiating supportive preclinical studies to explore the basic science of Oxycyte's oxygen delivery capabilities for the treatment of damaged brain tissue, and the effects of higher Oxycyte doses than have been used in previous studies, as well as the potential effects of administering second doses of Oxycyte.
  • Vidacare (San Antonio) reported receiving FDA approval for its bone-marrow biopsy system for hematology/oncology. The new technology is designed to increase control, improve core capture rates and reduce patient discomfort during bone-marrow biopsy procedures. Vidacare will market the lithium-battery powered device under the OnControl Bone Marrow Biopsy System brand. Bone marrow biopsies are necessary for the diagnosis and management of lymphoma, leukemia, myeloma and other hematological disorders. Vidacare develops advanced intraosseous (through-the-bone) access medical technology.
  • Ymed (San Diego) said it has completed its first U.S. cases with its VascuTrak II PTA dilation catheter. The catheter is a 5 Fr compatible, single-operator, rapid exchange system, Ymed said. It is designed and indicated for vascular intervention of a wide range of peripheral arteries, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Ymed makes products for vascular intervention, providing less-invasive therapy for a range of circulatory diseases.

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