An FDA advisory panel has recommended the approval of Hologic Inc.'s Adiana female contraception device for permanent sterilization. The device is used as an alternative, minimally invasive method to tubal ligation and can be performed in a doctor's office using local anesthesia. In a 10-3 vote, FDA recommended the approval under certain conditions, including long-term follow up of current pivotal trial patients, more specific labeling, and a new postapproval study of new patients and doctors. The procedure, which takes about 15 minutes, uses radio signals to make a lesion inside the fallopian tube. Once a catheter introduces a soft material (smaller than a grain of rice) into the tube, tissue grows on and around the material to create a permanent blockage. Women can resume their normal activities in one day, versus conventional bilateral tubal ligation, which is...
December 14th, 2007
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FDA has issued public health notifications to healthcare practitioners about dangers associated with radiofrequency ablation devices and dental handpieces. The agency said it has received reports, and seen others in medical literature, of deaths associated with lung tumor ablation from RF ablation devices, and that technical use of the device may be to blame in some cases. It cautions that RF ablation devices have not been cleared specifically for lung tumor ablation, and their manufacturers cannot market them for that purpose. The agency said that if a doctor wishes to use these devices for lung tumor ablation, he or she should enroll patients in an approved clinical study, where training is available. The agency has also received reports of serious patient injuries, including third-degree burns, associated with the use of poorly maintained electric...
December 13th, 2007
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If you're a patient with a recalled device implanted in your body, do you expose yourself to risky surgery to remove it, or do you leave it in and hope for the best? read more >>
December 13th, 2007
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During a panel discussion on cardiovascular devices at today's RBC Capital Markets 2007 Healthcare Conference, John Capek, MD, Abbott's executive vice president for medical devices, was asked how he expects its much-awaited drug-eluting stent Xience to perform in the U.S. marketplace once it has been approved next year. He said that one year after its European launch, Xience took more than 20% of the market, and the technology took more than 30%, if you factor in sales of Promus, Boston Scientific's version of the same stent. And he expects something similar to happen in the United States. But why, if Xience and Promus are basically the same thing, are many more physicians opting for Xience? Especially since Boston Scientific has been a player in the DES market for years and Abbott has not? Because, Capek said, Boston Scientific continues to focus its DES marketing on its first-generation product, Taxus. This despite growing amounts of...
December 12th, 2007
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FDA yesterday approved Zimmer Holdings' NexGen LPS-Flex Mobile Knee, reports the Associated Press. The implant differs from most other artificial knees in the mobility it can offer. Zimmer said its product is designed to accommodate active deep flexion of up to 155 degrees for patients who are otherwise capable of that level of flexion, versus the 120 degrees of other implants. The knee can be implanted in a minimally invasive procedure.
December 12th, 2007
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Novo Nordisk and Pfizer announced that they have settled Novo Nordisk's lawsuit alleging Pfizer's Exubera violated its patents for inhaled insulin, Reuters News reports. Terms were not available. The product had remained on the market after a judge cited patient needs in denying Novo Nordisk's request to require its withdrawal. This closes the book on Pfizer's involvement with the much-hyped Exubera. After the product failed to get much of a foothold on the market, the drug giant returned its rights to its co-developer, Nektar Therapeutics. It also paid Nektar $135 million to settle a contract dispute related to Exubera. Let's hope Nektar can do a better job marketing it than Pfizer did.
December 11th, 2007
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Knee and hip replacements have provided incredible revenue growth for orthopedics companies in recent years. Following behind them may be shoulder replacements, reports the Associated Press. Ortho companies are selling more shoulder implants and making them better, the article states, in part because baby boomers have insisted on continuing to perform activities such as playing golf longer than their parents did, even when confronted by arthritis. And CMS reports that payments for shoulder-replacement surgeries rose 13% from 2005 to 2006. Players include U.S. giants Zimmer, Stryker, DePuy, and Biomet, as well as France's Tornier.
December 10th, 2007
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Edwards Lifesciences Corp. (Irvine, CA) is selling its LifeStent peripheral vascular product line to C.R. Bard Inc. (Murray Hill, NJ) for up to $140 million. According to Edwards chairman and chief executive Michael Mussallem, the LifeStent product has resulted in "operating losses" for the company. Edwards will get about $75 million in cash at the closing of the deal, which is expected in January. The company will also receive $65 million in cash when certain milestones are reached, like FDA approval of additional product indications. Mussallem said that the deal will affect about 150 employees and will help Edwards increase its investments in the heart valve and critical care business.
December 7th, 2007
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The isotope used in radiopharmaceuticals for the majority of nuclear medicine imaging studies could be in short supply until January, following production issues at a Canadian reactor, Reuters reports. Atomic Energy of Canada Ltd. said delays in work on its National Research Universal reactor mean it won't be back up to full capacity until mid-January. Isotopes from that reactor are used by MDS Inc. and its subsidiary MDS Nordion, which supplies more than 50% of the world's medical isotopes. When injected into the body, they give off radiation that can be imaged by a camera to diagnose cancer and other diseases. That means some who may need to have such a test performed won't be able to have it done right away. UPDATE: The Canadian government is...
December 6th, 2007
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Legislation that could improve patient access to diagnostic tools has been introduced in Congress, according to an AdvaMed release. The bill would update and modernize Medicare reimbursement policies for laboratory testing. It would establish a pilot program to test a new payment system for molecular diagnostics -- which did not exist when the current system was implemented. It would also set up an appeals process to correct "historic errors," and take other steps to make the coverage process more transparent. The diagnostics industry has been clamoring for something like this for years, and for good reason, as diagnostics account for less than 2% of healthcare costs, yet influence as much as 70% of medical decisions. So this bill, sponsored in the Senate by Sen. Charles Schumer (D-NY) and in the House by Reps. Bobby Rush (D-IL), Michael Ferguson...
December 5th, 2007
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