Artes Medical (San Diego), focused on making a new category of aesthetic injectable products for men and women, reported FDA approval of ArteFill, calling it "the first and only non-resorbable aesthetic injectable implant approved by the FDA." The product is indicated for the correction of facial wrinkles known as nasolabial folds, or smile lines. Unlike existing dermal fillers that are completely metabolized by the body, ArteFill represents the first product in a new category of non-resorbable dermal fillers providing a permanent support structure for enduring wrinkle correction, according to Artes. ArteFill contains a combination of ArteFill Precision-Filtered Microspheres suspended in a carrier gel containing purified bovine collagen. Artes said it will begin marketing and selling ArteFill to dermatologists, plastic surgeons and cosmetic surgeons in the U.S. through its direct sales force.

CPC of America (Sarasota, Florida) reported that its subsidiary, Med Enclosure , in its preliminary findings of the randomized, prospective, multicenter trial of the MedClose VCS produced successful results with no adverse affects reported in diagnostic and interventional studies. Trial of the MedClose VCS as a "non significant/low-risk" device determined by both a U.S. Independent Review Board and a Canadian Independent Review Board — with subsequent approval by the Canadian Health, Health Products and Food Branch, Therapeutic Products Division for Protocol #CL-7000 — is intended to seal femoral arterial puncture sites and reduce time to hemostasis and ambulation in patients who have undergone interventional and diagnostic catheterization. The MedClose VCS is a catheter-based system that uses approved biologic fibrin sealant with approved labeling to rapidly seal arterial puncture sites following diagnostic angiography, interventional cardiology and radiological procedures.

HydroCision (Billerica, Massachusetts) reported that it will sponsor the training of spine surgeons at a Korean venue to perform a new, herniated disc repair procedure called HydroDiscectomy. This minimally-invasive procedure uses a high-velocity waterjet to decompress herniated discs, providing relief to patients suffering from back and/or leg pain. The HydroDiscectomy training will be performed in a "live" procedure by Richard Nussbaum, MD, of the Los Angeles Orthopaedic Institute, on Nov. 4, during the 17thannual Spine Total Care: New Technologies in Spinal Surgery meeting in Seoul.

Hydromer (Branchburg, New Jersey) has developed an anti-thrombogenic polymer coating complex (F202) designed to minimize blood coagulation. The surface bonding capabilities of the F202 polymer, which maintains long-term non-leaching properties, "are outstanding on a wide variety of medical materials such as cardiovascular devices and stents, hemodialysis equipment and intravenous catheters," the company said. Hydromer said it will be seeking medical device manufacturers who will enter into confidentiality agreements with non-analysis restrictions, submit their device samples for trial coating and provide feedback to Hydromer.

Nanogen (San Diego), a developer of diagnostic products, said that it has been issued four patents by the U.S. Patent and Trademark Office for inventions related to diabetes and Alzheimer's disease biomarkers, the most recent patents in a series describing biomarkers associated with these diseases. U.S. Patent No. 7,125, 678, "Protein biopolymer markers predictive of type II diabetes," U.S. Patent No. 7, 097,989, "Complement C3 precursor biomarker predictive of type II diabetes," and U.S. Patent No. 7,094,549, "Fibronectin biopolymer marker indicative of insulin resistance," relate to the use of mass spectrometry and time-of-flight detection to identify biopolymers that characterize type II diabetes. These markers could potentially be used in applications of disease risk assessment and development of therapeutic avenues, the company said. In addition, U.S. Patent No. 7,101,680 "Method for detecting the presence of monomeric brain associated human glutamine synthetase," relates to a method for detecting a biochemical marker, human glutamine synthetase, by immunoassay as a potential diagnostic for Alzheimer's disease. In addition, a method for distinguishing between AD and non-AD dementia is disclosed.

Shire (Basingstoke, UK) said that its Attention Deficit Hyperactivity Disorder (ADHD) patch, Daytrana (methylphenidate transdermal system), has "significant" efficacy in reducing the symptoms of ADHD in children aged 6 to 12, even when the ADHD patch is taken off earlier than the recommended nine hours. The ability to remove the patch earlier than the recommended 9-hour wear time allows the opportunity to manage late-day side effects, such as lack of appetite or difficulty sleeping. The phase IIIb clinical trial results were reported at a scientific meeting of child and adolescent psychiatrists in San Diego. The company said Daytrana is the only patch medication FDA-approved by to treat the symptoms of pediatric ADHD. Daytrana combines the active ingredient, methylphenidate, with Noven's DOT Matrix transdermal technology.

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