• Allergan (Irvine, California), the makers of Botox, reported FDA approval of the Juvederm gel family of products, next-generation hyaluronic acid dermal fillers that provide a smooth, long-lasting correction of facial wrinkles and folds. According to the company, Juvederm's formulations result in a smooth, natural look and contain the highest concentration of non-animal and cross-linked hyaluronic acid of any dermal filler currently available. These attributes provide optimal results with a single treatment in the majority of patients and deliver sustained results for up to six months or longer, according to the company.

• Cardium Therapeutics (San Diego) reported that meta-analysis findings of its AGENT clinical studies conducted by Schering (Berlin) showed positive effects following intracoronary angiogenic therapy in both men and women with heart disease. The data were presented at the American Society of Gene Therapy meeting in Baltimore. The data relates to the company's lead product candidate, Generx (Ad5FGF-4), a DNA-based growth factor therapeutic being developed for use by interventional cardiologists as a one-time treatment to promote and stimulate the growth of collateral circulation in the hearts of patients with ischemic conditions. As summarized by the AGENT clinical investigators in the abstract presented at the meeting, “the results of this meta-analysis suggest that Ad5FGF-4 may have a clinically meaningful and measurable effect on ETT [exercise treadmill test] and other measures of angina in women with recurrent angina, and potentially in both men and women that are older than 55 and have limited exercise capacity.”

• Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) said that clinical investigators provided an update on the company's ongoing BrainGate Neural Interface System (BrainGate) pilot clinical trials at the recent American Society of Stereotactic and Functional Neurosurgery meeting in Boston. Presentations included new data from the surgical, neurological and scientific efforts that have led to the use of the BrainGate System by those with quadriplegia to control computer interfaces using thought. The preliminary performance data included initial results from the third trial participant, who is unable to speak as a result of a brainstem stroke. The third participant has been able to control a cursor with significantly greater stability, to stop cursor movement at will, and to “click” on icons using imagined movements with the aid of an enhanced BrainGate interface. The third participant also has used the enhanced BrainGate operating system to type messages using assistive software.

• Diagnostic Ultrasound (Bothell, Washington) reported the introduction of a new rigid, reusable stylet to facilitate fast, easy endotracheal intubations. Designed specifically for use with the GlideScope Video Laryngoscope, the rigid stylet conforms to the GlideScope blade shape, a patented design to improve airway view, and eliminates the need to manually shape the stylet to fit down the airway. The rigid stylet, made of stainless steel, is reusable and can be cleaned easily along with other surgical instruments, using an autoclave.

• PLC Systems (Franklin, Massachusetts), a provider of cardiac laser technologies, said that a review of new cardiac tissue regeneration research was presented at the annual meeting of the Asian Society for Cardiovascular Surgery in Osaka, Japan. Focused on the intramyocardial application of bone marrow-derived stem cells in combination with CO2 transmyocardial revascularization (TMR), the presentation included data on stem cell therapy alone, stem cells with coronary artery bypass graph (CABG) surgery, and stem cells combined with CO2 TMR. The researchers concluded that stem cells combined with CO2 TMR provide an increased improvement in cardiac function in heart failure patients when compared to stem cells alone or stem cells with CABG. The company introduced its CO2 TMR Heart Laser technology at the meeting, which it said is the first TMR angina relief device approved by both the Japanese Ministry of Health, Labor and Welfare and the FDA.

• Tomen America (New York) said a study in the current edition of Diabetes Care demonstrates that the new GlycoMark blood test is a better measure of after-meal or postprandial glucose levels compared to standard tests for diabetes. The company called it “a very important finding” as elevated after-meal glucose levels are associated with cardiovascular complications, the leading cause of death in patients with diabetes. The study shows that although the current gold standard diabetes test, hemoglobin A1C, may indicate adequate control of glucose levels, after-meal glucose levels may still be elevated. The GlycoMark test, which measures circulating levels of 1,5- anhydroglucitol (1,5-AG), a sugar similar to glucose, reflects after-meal glucose levels over the previous one to two weeks. The authors of the study conclude that, “1,5-AG was reflective of varying postmeal glucose levels, despite similarities in A1Cs. Thus, the 1,5-AG assay may facilitate achieving good glycemic control in patients with suboptimal A1Cs by identifying patients in whom postprandial glucose elevations predominate.”

• Vascular Solutions (Minneapolis) reported the U.S. and international launch of its Skyway support catheters for wire support and exchange in complex interventions. The Skyway OTW and RX support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and coronary vasculature by facilitating placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents. The Skyway catheters provide 1.9 Fr ultra low-profile wire support for easy lesion entry and crossing with a hydrophilic coating on the distal 20 cm to glide through tortuous anatomy. The Skyway RX catheter features a rapid exchange design that allows delivery over an in-place 180 cm guidewire for wire support. The Skyway RX's wire exchange simplicity allows exchange of the guidewire without wire extension.

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