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| MEDICAL DEVICE NEWS |
Study compares performance of Cook's Zilver Biliary Stent with alternative solutions
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Results of the so-called MOZART study found that the overall clinical success of Cook Medical's non-foreshortening nitinol Zilver Biliary Stent, now available on a 25% smaller 6 FR introducer, parallels the effectiveness of Boston Scientific's Wallstent. The MOZART study confirms that self-expanding metal stents (SEMS) provide a higher level of patient care and clinical efficacy than alternative solutions. The study involved the largest international, randomized, controlled trial of SEMS in the treatment of biliary obstructions. |
| Cook Medical's non-foreshortening nitinol Zilver® Biliary Stent | Learn more. |
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Titanium medical implants could last longer Using NSF funding in the area of nanotechnology research, Professor Leon Shaw and assistant professor Yong Wang, Dept. of Chemical, Materials & Biomolecular Engineering at the University of Connecticut, Storrs, are combining nano-materials with biomedical engineering to develop titanium/hydroxyapatite orthopedic implants designed to improve implant longevity and reduce the need for revision surgery.
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NiTi Surgical Solutions announces successful first application of ColonRing
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NiTi Surgical Solutions, headquartered in Israel, announced in December, 2009 that its ColonRing anastomosis device (launched in the U.S. in May 2008 and successfully applied in thousands of patients) has been used for the first time in a colorectal surgery in China. Prof. Cai, Director of Colorectal Cancer Center at The Fudan University Shanghai Cancer Hospital performed a sigmoidectomy (anterior resection) on a 52-year old patient using the ColonRing. (Editor’s note: This news story follows up a story published on the ASM Newswire on October 19, 2009). |
| ColonRing: bowel anastomosis device | Learn more.
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Medtronic introduces Sovereign spinal system Medtronic Inc., Minneapolis, launched its Sovereign spinal system, an intervertebral body (interbody) fusion device designed to stabilize the spine and promote bony fusion, which involves the joining of two bones together, such as adjacent vertebrae. The system, made of polyetheretherketone (PEEK), incorporates a lens-shaped device with three holes for the placement of titanium screws, which protrude through the device and stabilize the adjacent vertebral bodies while preventing expulsion of the implant.
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Micro-introducer kits offer minimally invasive percutaneous procedures
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AngioDynamics, Queensbury, N.Y., launched a new family of micro-introducer kits featuring a stiffened introducer option, which allow percutaneous introduction of a guide wire or catheter into the peripheral vasculature during minimally invasive percutaneous procedures using a 21 gauge needle. The new kits include a needle, micro-introducer, and 0.018 in. diameter guide wire. |
| Micro-introducer kits are designed for micro access. | Learn more. |
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BioMedical imaging system collects, classifies and analyzes hereditary skeletal disorders
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Scientists at IBM Israel and the Rizzoli Orthopedic Institute in Bologna, Italy, are creating advanced tools to improve diagnosis and treatment plans for hereditary skeletal disorders. The scientists are collaborating on a comprehensive system called BioMedical Imaging Management Solution (BioMIMS) that will collect, classify and analyze family histories of hereditary skeletal diseases. |
| Medical IT hopes to improve understanding of rare hereditary skeletal disorders. | Learn more.
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Wireless heart pump offers new hope to heart patients Scientists at The University of Auckland’s Bioengineering Institute, New Zealand, developed the technology to power a wireless heart pump, which could offer an alternative to heart transplants. The pump uses magnetic fields to transfer power through a person’s skin rather than using wire cables. It can be powered this way 24 hours a day for a person’s lifetime. A new company, TETCor, was created to commercialize the technology.
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FDA schedules public meeting in February on premarket clearance process for medical devices The U.S. Food and Drug Administration (FDA) scheduled a public meeting on Feb. 18, 2010 to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the U.S. The FDA has convened its own internal working group to evaluate and improve the quality and consistency of the agency’s decision-making in the 510(k) process as well as its administration of the program. The FDA receives more than 3,000 510(k) submissions each year.
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University of Wollongong on quest to develop first bionic eye Researchers at University of Wollongong (UOW), Australia, who helped advance the pioneering bionic ear are now working on materials aimed at developing a bionic eye. Australia’s Federal Government is backing the quest to develop the first bionic eye with $48.5 million in funding. No funds will go to UOW, but the university is working closely with the bionic eye research consortium and the funding would boost the entire bionics field, according to Professor Gordon Wallace, head of UOW's Intelligent Polymer Research Institute.
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FDA approves left ventricular assist system for severe heart failure patients
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The U.S. Food and Drug Administration (FDA) approved Thoratec Corp.'s HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for a heart transplant. HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist. |
| Continuous-flow, left ventricular assist system | Learn more.
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New hydrogel material could advance efforts in tissue engineering
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Using water, clay and a new designer compound, scientists at University of Tokyo, Japan, created a strong moldable hydrogel that can heal itself in seconds when split in two. The gel is more than 50 times stronger than comparable squishy self-healing materials. Hydrogels possibly could serve as scaffolding for growing new tissue, as matrices for keeping drugs in their targeted area, or as replacements for damaged cartilage. |
| Using simple techniques, scientists have created a moldable gel that has superior strength and could lead to new routes for making artificial tissues. | Learn more.
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U.S. clinical trials begin for next-generation conformable GORE TAG thoracic endoprosthesis
 Next-generation conformable GORE TAG thoracic endoprosthesis |
W.L. Gore & Associates (GORE), Flagstaff, Ariz., announced the first human implants of the next-generation conformable GORETAG thoracic endoprosthesis in the U.S. for the treatment of traumatic transection of the thoracic aorta. The first implants were performed at Hennepin County Medical Center in Minneapolis and at Scott & White Hospital in Temple, Texas. The trial should illustrate the device’s capabilities and help show that thoracic endografts can offer patients with traumatic aortic transection a less invasive alternative. |
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| CONFERENCES & SEMINARS |
Medical materials training at your location ASM has conducted on-site training at the leading medical device companies all over the globe – why not let us come to you, too! We have recruited world-renowned experts who will come to your site – to train your staff – in your lab – with your equipment – to solve your problems.
Course titles include Stainless Steels, Cobalt-Chomo, Titanium, Nitinol, Polymers, Textiles, Drug Delivery, Testing for Combination Devices, Meeting Functional Requirements in Design, Biomedical Microdevices and Metallographic Techniques for Medical Devices.
John Cerne, ASM Training Specialist, will work with you to meet your training needs – from a one day course up to a full week course – to help you gain a fully knowledgeable, trained staff ready to give you the competitive edge.
Call John directly at 440-338-5417 or by email.
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Balmy breezes expected in Minneapolis for the MPMD 2011 Conference & Expo Materials & Processes for Medical Devices Conference & Exposition August 8-10, 2011 Hilton Minneapolis Minneapolis, Minn.
MPMD returns to Minneapolis in 2011, a city known for its idyllic summer weather*. Building on a great 2009 conference and exposition, MPMD 2011 will again bring together materials scientists and engineers, metallurgists, product designers, researchers, and clinicians. MPMD 2011 will continue and elevate the tradition of excellence and innovation in presenting the state-of-the-art in biomaterials science and engineering of medical devices.
*The normal temperature range for Minneapolis in August is 60-80 °F.
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