Biocomposites, the pioneers in synthetic bone graft materials have launched geneX ds, a dual syringe mixing and minimally invasive delivery system containing geneX, the unique resorbable bone graft material with a negative surface charge. The powder and liquid components of geneX are provided pre-packed in separate syringes. The syringes connect together and allow a faster, simpler and cleaner way for mixing geneX. The resulting setting paste can then be delivered through a 3.15" dispenser (included). geneX ds is ideal for difficult-to-reach surgical sites or minimally invasive procedures. geneX is a synthetic bone graft material with a unique bi-phasic composition manufactured through a proprietary process ZPC®
Stereotaxis (Nasdaq: STXS) announced that the Celsius® RMT ThermoCool® catheter has been approved by the U.S. Food and Drug Administration for use with Stereotaxis' magnetic navigation system for the treatment of Type 1 atrial flutter. The product is the fifth advanced ablation catheter resulting from the on-going co-development agreement between Stereotaxis and Biosense Webster to design and distribute magnetically enabled catheters for mapping and ablation. The Celsius® RMT ThermoCool® catheter was granted CE mark for distribution in the European Union in October 2009. The Celsius® RMT and NaviStar® RMT catheters are the only magnetic catheters accurately matched to the navigational software of the Niobe™
Dune Medical Completes Enrollment In MarginProbe TM Pivotal Trial For Real Time Detection Of Cancer During Breast Conservation Surgery
Dune Medical Devices announced the completion of patient enrollment in the MarginProbe™ pivotal clinical trial. The MarginProbe procedure provides surgeons with real-time detection of cancer at the edges of the tissue removed during breast conservation surgery (BCS), which is the only way to ensure the complete removal of the tumor from the breast. The randomized, controlled trial includes 664 women who underwent BCS at one of 21 leading medical facilities, with 18 in the US and three in Israel. "This trial is one of the largest randomized, controlled trials for intraoperative margin assessment ever undertaken. Completing enrollment in only 15 months is a significant accomplishment, " said lead investigator Lorraine Tafra, MD, FACS, Medical Director of Anne Arundel Breast Center, Annapolis, MD.
Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as they lack appropriate FDA clearance review and approval for safety and effectiveness. The agreement was part of a consent decree of injunction signed by Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund. "This action halts the manufacture of these products until the manufacturer comes into compliance with federal law, " said Jeffrey Shuren, M.
Microlife's WatchWT MedGem R Device Will Be Used To Assess Metabolic Changes In The Biggest Loser trade; Contestants
Microlife Medical Home Solutions, Inc. (MiMHS) announces The Biggest Loser medical staff will implement the MedGem indirect calorimeter to assess metabolic changes in program contestants. The MedGem handheld indirect calorimeter is an FDA-cleared, Class II, medical device that assesses metabolic rate by measuring a patient's resting oxygen consumption. "Resting metabolic rate (RMR) makes up approximately 70% of an individual's daily energy needs. Understanding a patient's calorie needs is extremely important when establishing a weight loss plan, " said Dr. Scott O. McDoniel, Director of Clinical Affairs for Microlife Medical Home Solutions, Inc.
Surgeons can now practise keyhole surgery to remove tumors on a "virtual 3D liver" before doing it in real patients; the new system, developed under the pan-European EUREKA Odysseus project, will help to reduce risks to patients and also enable surgeons to take expert advice before doing operations. Over 44 months and at a cost of more than 7 million Euros, German, French and Norwegian teams working on the the Odysseus project, also known as EUREKA project E! 3184, have developed systems that allow an expert to see 3D images of the liver of an individual patient. The Odysseus images are created using information from MRI and CT scans and show the liver and its tumors or other pathologies.