• Derma Sciences (Princeton, New Jersey) reported FDA clearance of the second dressing in its MediHoney line. This dressing is indicated for use on wounds with light-to-moderate exudate, and — based on its hydrocolloidal properties — forms a gel when it comes into contact with wound fluid to assist in promoting a moist environment conducive to healing. Hydrocolloids are the most commonly used advanced wound care dressings, as most chronic wounds fall into the category of light-to-moderate exudate. Derma Sciences makes wound care products.
  • DexCom (San Diego) said that it has received FDA approval to calibrate the SEVEN, its seven-day continuous glucose monitoring system, using any FDA-cleared blood glucose meter. With this approval, patients will be able to calibrate the system without using a connection cable. DexCom expects to launch this feature to new patients near the end of 1Q08 and upgrade existing patients during 2Q08. DexCom makes continuous glucose monitoring systems for people with diabetes.
  • Kerk Motion Products (Hollis, New Hampshire) reported the introduction of the Mini ScrewRail, a compact addition to the company's line of ScrewRail linear actuators. The Mini ScrewRail consists of a precision rolled lead screw, supported by sealed bearings and contained within a concentric steel guide rail, driving an integrated nut/bushing. The Mini ScrewRail is available in a .375" outside diameter, sizably smaller than typical diameters of .500" to 1.00." The Mini ScrewRail uses Kerk's Kerkote TFE coating on both the lead screw and guide rail, minimizing drag torque and extending wear life. In addition, Kerkite high performance polymers make the entire assembly self-lubricating and maintenance-free. Kerk Motion makes non-ball lead screws.
  • Kensey Nash (Exton, Pennsylvania) reported the first commercial product kit shipment of its bone void filler OsseoFit Porous Tissue Matrix to Biomet Sports Medicine, the sports medicine subsidiary of Biomet. The product kit will be used to expand the clinical use of the OsseoFit device beyond a select group of sites that have had access to the product to date. OsseoFit is a implant manufactured from Kensey Nash's Porous Tissue Matrix technology, which creates foamed scaffolds suited for tissue engineering applications. The OsseoFit uses several resorbable biomaterials including a proprietary collagen formulation, synthetic polymer and ceramic. This design creates a structure that is optimized for specific types of bone void filling indications. Kensey Nash specializes in products for the endovascular, sports medicine and spine markets.
  • Medtronic (Minneapolis) said that it has received FDA clearance for the Complete SE (self-expanding) biliary stent system, which is indicated for use in the palliative treatment of malignant neoplasms in the biliary tree - cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids. U.S. sales of the new biliary stent will begin in a wide size range, with diameters of 4 mm - 10 mm and lengths of 20 mm - 150 mm. The company said that bench testing has shown the Complete to be accurate in terms of stent placement.
  • Visiogen (Irvine, California) reported the closure of enrollment in its Phase III study of the Synchrony dual optic accommodating intraocular lens. This study is evaluating the safety and efficacy of the device and the potential for functional near, intermediate and distance vision without the use of glasses in patients after cataract surgery. The Synchrony system is self-contained and ready for use without the need for lens handling by means of a preloaded injector. The dual optic lens is designed to be inserted through a 3.6 mm to 3.8 mm clear-corneal incision. The single-piece, 3-D lens unfolds in the eye upon insertion and features two optics connected by a spring system. The springs connect a 5.5-mm high power anterior optic and a 6-mm minus power posterior optic. The spring action moves the front optic and changes the eye's focus from near to far. Visiogen makes products for cataract and refractive patients.