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Prosthetics, Implants & Pacemakers
& Related Newswire
6/27/2006 9:31:00 AM | Boston Scientific to recall defective heart devices 
=(0) Boston Scientific has issued another recall for its Guidant division, on a variety of cardiac devices: some Insignia, Nexus and Contak Renewal pacemakers; and Ventak Prizm 2, Vitality, and Vitality 2 implantable defibrillators. A defect was found that could lead to premature battery failure. Five malfunctions, but no deaths, have been re...
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6/19/2006 6:58:00 PM | Pacemaker that can predict heart failure =(0) A new generation of pacemakers is being developed that can detect fluid retention and transmit information about a patient's heart to remote locations. It can warn a patient if trouble is looming, before symptoms develop, with the idea of reducing the need for hospitalization. One such device, the Medtronic Concerto, has recently been app...
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6/16/2006 7:02:00 AM | Johnson & Johnson to appeal stent ruling =(0) Boston Scientific has scored a point in their patent war against Johnson & Johnson. The companies are claiming each infringed the patents of the other with regard to various models of stents, wire mesh devices that are placed inside arteries. The latest ruling upholds a previous decision that Johnson & Johnson's Cypher stent infringed Bos...
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6/12/2006 4:23:00 PM | Medtronics targeted in St. Clair County again =(0) Medtronic is being sued by an Illinois man, claiming damages because the implantable defibrillator he received was later revealed to have a defective battery. He was subsequently hospitalized and is claiming personal and economic damages. The 24 counts in the lawsuit include fraud, negligence, misrepresentation and defective design...............
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6/8/2006 5:03:00 PM | Guidant never sent doctors letter about defibrillator risks =(0) Guidant considered warning doctors about a malfunction in its implantable defibrillator devices - but decided not to, according to documents. Instead of a warning letter that had been drafted, Guidant sent a routine "product update". Ultimately, Guidant ended up recalling the devices in question, and some pacemakers as well, after at least sev...
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6/5/2006 7:19:00 AM | Suits Target J&J Discs =(0) Lawsuits are piling up against Johnson & Johnson's Charite Spinal Disc. The first of its kind, it is marketed as an alternative to spinal fusion, providing a more natural range of movement; however when the surgery fails, it can apparently lead to further, dangerous surgery and disability. The company stands by its product, saying those for wh...
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6/2/2006 2:34:00 PM | Study Focuses on Cochlear Implant Placement =(0) For hearing-impaired children who are helped by a cochlear implant, studies show that two implants are often better than one, especially for younger children. Two implants improves speech perception in noisy conditions, and the improvement continues to develop for up to one year after the second implant......................
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6/2/2006 11:53:00 AM | 20 insurers sue over defective defibrillators =(0) Guidant faces a lawsuit over defective defibrillators - however this one is not from patients, but from twenty Blue Cross and Blue Shield Plans, which must bear the consequences of increased health costs for those harmed. Patients whose internal defibrillators have been recalled face a sobering dilemma: have the device replaced, or leave it in...
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5/31/2006 11:11:00 AM | UA doctor barred from research on humans =(0) The FDA has barred a University of Arizona cardiologist from conducting research using human subjects. Dr. Paul Fenster was found to have violated rules protecting patient safety after his own University reported him to the FDA. The research involved implanted Guidant heart pacemakers. Breaches of rules included using doctors and pat...
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5/19/2006 6:05:00 PM | Tonsil removal doesn't hurt cochlear =(0) Studies so far seem to indicate that the technique of electrosurgery does not interfere with the functioning of cochlear implants. Electrosurgery is often a preferred method of performing ear nose and throat surgery such as tonsillectomy. Many cochlear implant recipients are children who might eventually need such throat operations, so the saf...
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5/16/2006 7:31:00 PM | Competition about to heat up for J&J spine disc =(0) A second type of artifical spinal disc, made by Synthes Inc., is set to hit the market, awaiting final FDA approval. Medicare and insurance coverage for this type of procedure is slow in coming, however, because of reports of complications from the existing Johnson & Johnson Charite disc, and uncertainty whether disc replacement is a superior treat...
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5/16/2006 4:30:00 AM | New Guidant warning issued =(0) Boston Scientific has advised doctors that it discovered a flaw in certain defibrillator models made in March 2005. The models in question are the Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3, 4, and 4 AVT. The problem lies in a defective capacitor and doctors are urged to check their patients who have this device implanted. This is...
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5/15/2006 12:51:00 PM | Medtronic outlines its initiatives on pacemaker guides =(0) Medtronic, a medical device maker, has outlined improvements it is implementing to adhere to the guidelines recently recommended by the Heart Rhythm Society: It is expanding its panels that study performance trends and quality control; it is creating a patient advisory panel to improve communication with patients; it will work to pool data fro...
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5/10/2006 11:01:00 AM | Medtronic begins study on new ICD device =(0) Medtronic has begun a clinical trial to study a new device in the treatment of mild to moderate heart failure. The device is an implantable defibrillator, but also is able to transmit data via phone lines so that doctors can more closely monitor patient heart rate, pressure, body temperature and activity. .........
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4/28/2006 12:33:00 AM | BSX listens to Heart Rhythm Society =(0) Boston Scientific Corp. says it intends to implement all the recommendations put forth by the Heart Rhythm Society. These guidelines were developed following a recall of implanted cardiac defibrillators last year, and include: using remote monitoring to keep track of devices; independent committees for assessing device performance; direct...
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4/26/2006 5:06:00 PM | Heart Device Risks Examined =(0) A doctor's group, the Heart Rhythm Society, has called for better oversight of their products and better communication between medical device makers, doctors, and government with regard to defective devices and recalls. Several recalls occurred last year, some invoving Guidant, now owned by Boston Scientific. However another study found that peopl...
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4/26/2006 3:07:00 AM | Replacing heart device has high risk =(0) If your surgically implanted heart defibrillator is recalled, such as occurred recently with Boston Scientific devices - what do you do? Statistically, it is safer to not have it replaced, according to a new study, because risks of complications from the replacement surgery far outweigh risks of defibrillator failure. The study showed an ...
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4/26/2006 12:03:00 AM | Implantable Defibrillators Can Be Erratic, Studies Find =(0) Three studies, recently published in the Journal of the American Medical Association, examine the reliability statistics for implantable cardiac defibrillators. These devices are meant to detect an irregular heartbeat and deliver an electric shock to restore normal rhythm. Compared to pacemakers, which speed up the heartbeat with lower p...
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4/17/2006 1:51:00 PM | Kyphon responds to Medtronic lawsuit =(0) Medtronic, a medical device maker, is suing Kyphon Inc. for infringing on various patents relating to blood vessel catheters and spinal discs. It is also asking a judge to rule that it has not infringed upon several Kyphon patents. Rhetoric by the lawyers continues..........
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4/14/2006 6:18:00 AM | OC doctors disagree on value of artificial spinal disc implant =(0) The Charite spinal disc is the first artifical disc approved to replace damaged spinal discs. Its use is controversial, and Medicare is considering no longer paying for the procedure to insert it. A lawsuit filed in Massachusetts against DePuy, part of Johnson & Johnson, alleges that the disc caused the litigant severe back and leg pain.&...
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