A Materials Database for Medical Devices

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10 DEVICES Artificial cornea saves eyesight An artificial cornea that is to be clinically tested in early 2008 has been developed in the EU-funded CORNEA project, by research scientists at the Fraunhofer Institute for Applied Polymer Research IAP in Potsdam, and the Department of Ophthalmology at the University Hospital of Regensburg. “Our artificial corneas are based on a commercially available polymer which absorbs no water and allows no cells to grow on it,” says IAP project manager Dr. Joachim Storsberg. “Once our partner Dr. Schmidt Intraokularlinsen GmbH has suitably shaped the polymers, we selectively coat the implants: We lay masks on them and apply a special protein to the edge of the cornea, which the cells of the natural cornea can latch onto. In this way, the cornea implant can firmly connect with the natural part of the cornea, while the center remains free of cells and therefore clear.” The optical front part of the implant is coated with a hydrophilic polymer, so Biodegradable plates and screws that can stabilize the vertebrae during cervical spinal fusion procedures have been announced by Inion, Weston, Fla. The CE Mark from the British Standards Institution (BSI) has been received for the Inion S-1 Anterior Cervical Fusion System enhanced with a radiographic marker. This advance is designed to facilitate the post-operative evaluation of the site of surgery with X-rays, by allowing the surgeon both to confirm the accurate positioning of implants and to visualize and assess the healing progress. Chris Lee, Chief Executive Officer, Inion Oy, 2800 Glades Circle Suite 138, Weston, Florida, 33327; tel: +44 1279 874 222; U.S. tel: 954/659-9224; www.inion.com. An implantable miniature telescope is under development for end-stage age-related macular degeneration by VisionCare Ophthalmic Technologies Inc., Saratoga, Calif. Although the device has not yet been approved by the Food and Drug Administration, physicians have described a recommended surgical technique to ensure proper product placement while minimizing damage to the eye. The telescope is 4 mm long and contains two wide-angle glass microlenses. VisionCare Ophthalmic Technologies Inc., 14395 Saratoga Ave, Ste 150, Saratoga, CA 95070; tel: 408/872-9393; fax: 408/872-9395; www.visioncareinc.net. A Nitinol spine implant that provides uniform compression while the alloy’s structure transforms into a state approximately 20% stronger than 316L stainless steel has been developed by BioMedical Enterprises Inc., San Antonio, Texas. Called OSSpine, the U.S. FDA has given 510(k) marketing clearance for anterior fixation of the cervical spine. Made of Nitinol, the OSSpine implant is inserted while in its malleable state at room temperature. BME’s patent-pending OSSforce Implant Controller enables the implant to be safely heated to activate its shape change and impart compression forces across the fusion site. Bio- Medical Enterprises Inc., Texas Research Park, 14785 Omicron Dr., Suite 205 , San Antonio, TX 78245; tel: 210/677-0354; http://www.bme-tx.com. that it is constantly moistened with tear fluid. For more information: Joachim Storsberg, Fraunhofer Institute, Potsdam, Germany; tel: 49 331 568-1321; joachim.storsberg@iap. fraunhofer.de; http://www.fraunhofer.de/fhg/EN/bigimg/2007/ rn10fo3g.jsp. DePuy Orthopaedics launches new hip bearing system DePuy Orthopaedics Inc. has announced a new option for restoring hip mobility in patients who require total hip replacement: the Pinnacle Acetabular Cup System AltrX hip bearing, a polyethylene bearing liner. The AltrX polyethylene bearing is used with DePuy’s exclusive Pinnacle Acetabular Cup System, the only product available that provides surgeons with the option of choosing a polyethylene or metal insert with the same outer titanium cup that replaces the socket of the natural hip. In laboratory simulations, AltrX polyethylene liners achieved a 92% wear reduction over conventional polyethylene liners, while maintaining excellent mechanical integrity and oxidative resistance. A unique AltraLink material enhancement process enables the liners to achieve excellent mechanical toughness and oxidative resistance, which helps provide long-term durability of the implant. For more information: DePuy Orthopedics Inc., a Johnson & Johnson Co., 700 Orthopaedic Drive, Warsaw, IN 46581; tel: 800/366-8143; www.depuy.com. Plating systems expand elbow management Small Bone Innovations Inc. (SBi), announces the launch of the R- Head Lateral Radial Head Implant System. To further augment its Elbow Management System, the company has also launched the R- Head Plating System for internal fixation of proximal radius fractures. The R-Head Lateral Implant is a side-loading radial head prosthesis that allows for a minimally invasive approach and exposure in radial head replacement surgery. The head and stem of the implant connect by the means of a dovetail locking mechanism that does not require a set screw, saving time in the operating room. The stem of the R-Head Lateral implant is plasma-coated with titanium for immediate stability in the canal and optimum osteointegrating properties. As with SBi’s existing implants, the stem has a 12-degree curve to match the anatomy of the radius. This stem is available with a 2 mm standard collar or a 6 mm extended collar. For more information: Anthony G. Viscogliosi, Small Bone Innovations, 1380 S. Pennsylvania Avenue, Morrisville, PA19067; tel: 215/337- 6390; http://www.totalsmallbone.com. 72 ADVANCED MATERIALS & PROCESSES/JANUARY 2008
DEVICES 11 Implantable contact lens corrects nearsightedness The U.S. Food and Drug Administration has approved the tiny Verisyse lens, made by Netherlandsbased Ophtec BV and its U.S. affiliate, for people with “healthy eyes” and “stable vision.” The implant is smaller than a contact lens and similar to those for treating cataracts, but it does not replace the eye’s natural lens. It is inserted through a small incision, and is centered over the pupil between the cornea and iris. “Unlike laser surgery, implantation . . . involves no removal of tissue, and the lens can be easily removed at any time in the future,” says Rick McCarley, president and chief executive officer of Ophtec’s U.S. unit. The agency says Ophtec must study the device for five more years to monitor eye problems, including cataract development and detachment of the retina. Ophtec’s three-year clinical trial of patients with moderate to severe nearsightedness found vision improved to 20/40 or better in 92% of those studied, while 44% had 20/20 vision or better. Ophtec’s U.S. affiliate, Advanced Medical Optics, a medical device maker based in Santa Ana, California, will distribute the device in the United States. The lens is already marketed under the name Artisan in other countries. For more information: Rick McCarley, Advanced Medical Optics, 1700 E. St. Andrew Place, P.O. Box 25162, Santa Ana, CA92799-5162; tel: 714/247- 8200; www.amo-inc.com. MRI enables custom-fit total knee replacement Patients with degenerative knee conditions can now benefit from customfit knee replacements that are tailored to an individual’s unique body mechanics, size, and gender variations, says Dr. Mitchell Sheinkop, orthopedic surgeon at the Neurologic and Orthopedic Institute of Chicago. Developed by OtisMed Corp., this custom-fit approach enables surgeons to preserve more bone and ligaments, allowing for better implant fit and alignment. The implant is made in four steps. Prior to surgery, an MRI takes very precise measurements of the knee. Then, proprietary computer software creates a 3-D image, and virtually corrects the deformity to return the knee to its pre-arthritic state. Third, a computerized 3-D image of the implant is Shape-Matched to the anatomically correct virtual knee model. This helps determine the correct implant size and placement, based on normal knee anatomy. Last, spe- A heart pacemaker that could be powered by the beating heart rather than a battery has reportedly been designed by David Tran and colleagues at Stanford University, California. The team has come up with a number of designs that generate power by virtue of being attached to the outside of the heart. This causes, for example, a magnet to move through a coil, or a piezoelectric element to move in a way that generates current. The team says this could make implantable devices self-powering, or at the very least, increase the periods between replacements. David Tran, Stanford University, Stanford, CA 94305; tel: 650/723-0987; www.stanford.edu. Medtronic has received 510(k) marketing clearance from the FDA for the Complete SE (self-expanding) Biliary Stent System. The device is indicated for the treatment of cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids. U.S. commercial sales of the new biliary stent will begin immediately in a wide size range, with diameters of 4 to 10 mm and lengths of 20 to150 mm. www.medtronic.com The Coherex FlatStent PFO Closure System has been implanted for the first time in humans in Frankfurt, Germany. The surgeries mark the launch of a European clinical study of the device, made by Coherex Medical Inc., Salt Lake City, Utah. If all goes well, the device then will begin the long FDA approval process in the United States as well. Richard Linder, Coherex Medical Inc., 3598 W. 1820 South, Salt Lake City, UT 84104; tel: 801/433-9900; www.coherex.com. cial cutting guides are created for the surgeon. These patient-specific cutting guides indicate exactly where to make bone cuts so that the knee replacement is customized for the individual. For more information: Mitchell Sheinkop, Neurologic & Orthopedic Institute of Chicago, Chicago, IL 60640; tel: 773/250-0000; http://www.neuroortho.org. OtisMed Corp., 26250 Eden Landing Road, Hayward, CA 94545; tel: 888/684-7633; www.otismed.com. Device technologies improve minimally invasive surgery Creganna Medical Devices, Galway, Ireland, has developed three new innovations for minimally invasive surgery: PoleVault, MicroFlex, and Fusion Technology. The PoleVault hypotube improves kink resistance in stent placement catheters. A critical component of minimally-invasive catheters, used in conjunction with balloons and stents to open up clogged cardiac arteries, the PoleVault hypotube has 40% more kink resistance than other hypotubes. MicroFlex is a micro tube for small vasculature applications such as the neurovascular system. Fusion Technology is a breakthrough solution for Nitinol to stainless steel tube welding via patented technology. For more information: Paul Gratiano, Creganna Medical Devices, 450 Donald Lynch Boulevard, Marlborough, MA 01752; tel: 603/886-5116; 508/658-7146; paul.gratiano@creganna.com; www.creganna.com. ADVANCED MATERIALS & PROCESSES/JANUARY 2008 73
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
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Page 14 and 15: 12 INDUSTRY NEWS Edwards Lifescienc
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Page 19 and 20: ample calculations, based on case s
Page 21 and 22: The MultiPrep The MultiPrep System
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A Materials Database for Medical Devices

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