A Materials Database for Medical Devices

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18 BUSINESS BRIEFS Industry association AdvaMed says it is concerned about a new competitive bidding program for clinical laboratory services after the Centers for Medicare & Medicaid Services announced the San Diego area will be the first site for the project. The program requires competitive bidding arrangements for diagnostic laboratory payments under Part B of Medicare, which may prevent smaller, specialized labs from competing with larger firms. Advanced Materials Inc. has successfully achieved ISO 13485 certification, which signifies the positive assessment of the company’s medical device quality system. Alphatec Holdings has received 510(k) clearance from the FDA to market its Zodiac Luxe 4-mm diameter pedicle screw in concert with its Zodiac spinal disorder solution products. Medical device start-up Appiades Meditech has developed an electromagnetic device that accelerates the union process in bone fractures. Biomet Inc. announces the completion of its merger with LVB Acquisition Merger Sub Inc., a wholly-owned subsidiary of LVB Acquisition Inc., which is indirectly owned by investment partnerships directly or indirectly advised or managed by The Blackstone Group L.P., Goldman Sachs & Co., Kohlberg Kravis Roberts & Co. L.P. and TPG Capital. Cordis Corp., a Johnson & Johnson subsidiary, announces the completion of patient enrollment for its pivotal trial for the ExoSeal Vascular Closure Device. The ExoSeal features a synthetic bioabsorbable polymer and is being studied to determine whether it can enable expedited hemostasis. DePuy Orthopaedics Inc. has launched computer software designed to significantly enhance the field of computer-assisted knee replacement surgery. The Ci Essential Knee System is computer software that provides surgeons with a threedimensional view of the knee joint to help accurately align implants during knee replacement surgery. Edwards Lifesciences Corp. has received CE Mark approval for European commercial sales of its Sapien transcatheter aortic heart valve technology with the RetroFlex transfemoral delivery system. Inion, a company focused on the development of novel biodegradable medical implants, has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for extended indications for its Inion Hexalon biodegradable screw. Medtronic Inc. has received 510(k) marketing clearance from the FDA 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. Orthofix International N.V. has acquired the rights to all of the intellectual property related to the InSwing interspinous process spacer, which can be used in a minimally invasive surgical procedure involving minimal or local anesthesia. Qinetiq North America announces that its subsidiary, Harvard physicists have shown that specially treated diamond coatings can keep water frozen at body temperature, a finding that may have applications in future medical implants. Northwestern University researchers have shown that nanodiamonds are very effective at delivering chemotherapy drugs to cells without the negative effects associated with current drug delivery agents IsoTis Inc., an Irvine maker of artificial bone material, is being acquired by Integra LifeSciences Holdings Corp. for $51 million. BioMedical Enterprises Inc. has launched a new medical product, a Nitinol implant designed to fix irregular bone surfaces and structural problems in bone anatomy. Foster-Miller, has received international certification for quality management systems for both its Commercial Equipment and its Electronic and Electrical Systems Groups. Stryker introduces SDC Ultra, an all-in-one medical imaging information management system that archives surgical images and videos and records surgical footage in HD quality. Symmetry Medical Inc has entered into a definitive agreement to acquire Specialty Surgical Instruments and Ultra Containers of America, a leading provider of specialty surgical instruments and sterilization containers, for $15.1 million in cash on a debt free basis, subject to certain adjustments. Ulbrich Stainless Steels and Special Metals Inc. is pleased to announce the formation of Ulbrich of Austria, Gmbh. The new venture will be part of the Ulbrich Specialty Wire Group, which will now consist of five production facilities in three countries. Wright Medical Group Inc. has acquired certain assets of Metasurg, a company focused on development and marketing of surgical fixation and implant devices for foot and ankle surgery. The purchase consists of an initial cash payment of $2.5 million and potential additional cash payments based upon future financial performance of the acquired assets. Zimmer Holdings Inc. and its indirect wholly owned subsidiary ZMH Acquisition Co. announce that they have been successful in their bid to acquire OrthoSoft Inc., a leader in computer navigation for orthopedic surgery. 80 ADVANCED MATERIALS & PROCESSES/JANUARY 2008
The MultiPrep The MultiPrep System System 2376 E. Pacifica Pl Rancho 2376 E. Dominguez, Pacifica PlaceCA 902 Rancho Dominguez, CA 90220 (800) 675-1118 (US & Canada) (310) 635-2466 (Worldwide) The MultiPrep System enables precise semiautomatic sample preparation of a wide range of materials for microscopic (optical, SEM, TEM, AFM, etc.) evaluation. Capabilities include parallel polishing, precise angle polishing, sitespecific polishing or any combination thereof. It provides reproducible sample results by eliminating inconsistencies between users, regardless of their skill. The MultiPrep eliminates the need for hand-held polishing jigs, and ensures that only the sample makes contact with the abrasive. Features: � Front Digital Indicator displays real-time material removal/sample advancement, 1 micron resolution � Rear Digital Indicator displays vertical positioning (static) with zeroing function, 1 micron resolution � Precision spindle design indexes the sample perpendicular to the platen, and can rotate simultaneously � Dual axis, micrometer-controlled angular positioning of the sample (pitch and roll), +10/-2.5° range, 0.02° increments � Automatic sample oscillation, adjustable sweep with 6 speeds � Full or limited automatic sample rotation with 8 speeds � Gear-driven system available for applications demanding higher rotational torque, i.e. larger or encapsulated samples � Cam-locking system eliminates the need for tools and allows for exact repositioning of fixtures � Two (2) year warranty – parts and labor � Designed & manufactured by Allied in the USA Unequalled Sample Preparation Results of Medical Device Materials TiN on Stainless, CDIC Stainless Steel, BF Titanium, POL Quality Products for Metallographic Sample Preparation & Analysis TechCut 5 MetPrep 4 System TechCut 4 AxioObserver Microscope
Page 1 and 2: TECHNICAL AND BUSINESS NEWS FOR THE
Page 3 and 4: Editorial Staff Margaret W. Hunt Ed
Page 5 and 6: An Image Is Worth A Thousand Words
Page 7 and 8: Carbon nanotubes on anodized titani
Page 10 and 11: 8 TESTING/R&D Miniature magnetic se
Page 12 and 13: 10 DEVICES Artificial cornea saves
Page 14 and 15: 12 INDUSTRY NEWS Edwards Lifescienc
Page 16: 14 INDUSTRY NEWS DSM to extend its
Page 19: ample calculations, based on case s
Page 23: Materials Knowledge Leads to Better

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