• Angiotech Pharmaceuticals (Vancouver, British Columbia) and Orthovita (Malvern, Pennsylvania) reported the commercial launch of Vitagel. Orthovita has initiated distribution through its 40 direct sales representatives and roughly 20 independent distributors. The direct representatives will have a launch base that extends to more than 500 hospitals. As part of the previously reported consolidation of its Cohesion Technologies subsidiary (Medical Device Daily, Nov. 30, 2004), Angiotech said it expects a full transfer of production capabilities from Cohesion's Palo Alto, California, facility to Orthovita's Malvern facility to be complete by 3Q05. Vitagel Surgical Hemostat is designed for use in cardiovascular, orthopedic, urologic and general surgery indications to control bleeding. Vitagel uses autologous blood, thus reducing the risk of transmission of diseases associated with donor blood.

• Corautus Genetics (Atlanta) reported the publication of pre-clinical results of its gene transfer technology administered via drug-eluting stents. In a separate project, Corautus' technology is being tested in a Phase IIb trial, GENASIS (Genetic Angiogenic Stimulation Investigational Study), which is enrolling up to 404 patients with Class III or IV angina in about 25 cardiac medical centers in the U.S. In the GENASIS trial, defined doses of vascular endothelial growth factor-2 (VEGF-2) in the form of naked DNA plasmid, a non-viral vector, are delivered to diseased heart muscle tissue via Boston Scientific's (Natick, Massachusetts) Stiletto endocardial direct injection catheter system. In the preclinical study reported in a recent issue of Circulation, a team of researchers tested VEGF-2 gene transfer in an animal model of stent thrombosis. The results demonstrated for the first time that VEGF-2 could be delivered to blood vessels using drug-eluting stents and that this delivery led to accelerated growth of healthy endothelial cells while reducing pathological thickening of the artery associated with restenosis.

• Given Imaging (Yokneam, Israel) reported that a controlled study using PillCam SB was published in the January issue of Clinical Gastroenterology and Hepatology. The goal of the study was to assess the effects of daily NSAID usage on the small intestine using PillCam SB. The study found that severe injury was seen in 33% of NSAID users compared to 0% of the control group. “This study suggests there is a need for monitoring for intestinal damage among those patients using NSAIDS on a regular basis,“ said President and CEO Gavriel Meron. “This significant patient population needs evidence-based guidance to balance the risks of potential intestinal damage associated with daily use of NSAIDs, with the perceived cardiac risk associated with COX 2 inhibitors. We believe that PillCam SB will have a major role in this process.“ The PillCam SB video capsule is the only naturally ingested method for direct visualization of the entire small intestine.

• I-Flow (Lake Forest, California) reported that Dr. Volker Jacobs and Dr. John Morrison of the Fayette Medical Center (Fayette, Alabama) presented data highlighting benefits of its ON-Q PainBuster to reduce pain after mastectomy while reducing or eliminating the use of narcotics at last month's San Antonio Breast Cancer Symposium. By redefining recovery, ON-Q PainBuster is the standard of care for relieving post-surgical pain in patients undergoing a mastectomy at the medical center. In Jacobs' study, nearly 70% of the patients who used ON-Q PainBuster did not require any narcotics after undergoing a mastectomy. A 63% reduction of the absolute amount of narcotics used post-surgically was documented in the study.

• Nanogen (San Diego) reported that it was issued U.S. patent No. 6,838,053, “Platinum silicide permeation layer device with microlocations,“ by the U.S. Patent and Trademark Office. The patent relates to methods of making a covalently bonded permeation layer on a microchip. The technology described in the patent relates to Nanogen's advanced chip designs, which are used for analysis of biological molecules such as nucleic acids for diagnostic applications.

• Orqis Medical (Lake Forest, California) said the FDA has approved an expansion of the Cancion CRS clinical trial from eight to 40 medical centers nationwide, accelerating the trial's recruitment and enrollment efforts. The Cancion CRS therapy is a percutaneous cardiac recovery system being studied for its ability to create a “rest-to-recovery“ environment for congestive heart failure (CHF) patients. Enrollment in the MOMENTUM (Multicenter trial of the Orqis Medical CRS for the ENhanced Treatment of CHF, Unresponsive to Medical Therapy) trial began in September. The Cancion CRS is being studied for its ability to reverse the consequences of abnormal aortic flow, induce vasodilatation and improve renal blood flow. Studies also will focus on hemodynamic improvement, reduced ventricular and atrial volumes and improved renal function, as well as whether the CRS therapy may have a sustained effect after removal.

• Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of the GTS System for use in arthroscopic soft tissue reconstruction of the anterior cruciate ligament (ACL) in the knee. The GTS System is used to secure the lower, tibial end of a soft tissue ACL graft. Key to this system is the GTS Sleeve device, a woven mesh sleeve segmented into three tubular sections, called lumens. Two of these lumens hold graft tissue, and the third lumen accepts the GTS tapered fixation screw molded from bioabsorbable PLLA (polyllactic acid). As this tapered screw is tightened, it presses the graft tissue against the sides of the tibial tunnel. The PLLA material biodegrades over several years, and is dispersed from the patient's body naturally.