The Wall Street Journal has obtained an unredacted version of a 2002 lawsuit against Medtronic that contains some very damning allegations -- and was brought by a former lawyer for the firm, Ami Kelley. It states that the company gave spinal surgeons "a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska, and patent royalties on inventions they played no part in." The lawsuit, brought to recoup Medicare-fraud-related damages for the government, was one of two that led to Medtronic's $40 million settlement with the government in 2006. Kelley said she was fired by Medtronic after questioning the payments. That settlement may now be in jeopardy, as the other lawsuit's plaintiff, Jacqueline Poteet, has appealed the dismissal of her suit, saying the settlement was too small. Whistleblowers who help the government recover money...
September 25th, 2008
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Boston Scientific announced that it has received FDA approval for the Taxus Express2 Atom drug-eluting stent system, which is the first drug-eluting stent designed for small coronary vessels. It is the first DES approved by FDA for use in vessels as small as 2.25 mm in diameter. The firm also got approval for the Taxus Express2 DES, which is indicated for treatment of in-stent restenosis in bare-metal stents. This gives Boston Scientific four DES models on the U.S. market, the most of any company. The other two are the original version of Taxus and Promus, the firm's version of Abbott's Xience V, originally developed by Guidant. UPDATE: Boston Scientific CEO Jim Tobin says he expects FDA approval of the firm's next-generation DES, Taxus Liberte, to come...
September 25th, 2008
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By now, most device companies probably know this. What they also should know is that delivering products internationally takes careful preparation and research from the start. Take Covidien, for example. After its first year as an independent company, it reported nearly $9 billion in revenue for 2007. What's the company's strategy? Joe Almeida, president of Covidien's medical device business, told MD...
September 25th, 2008
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Data from a Medtronic-sponsored registry of heart-failure patients shows they are getting inconsistent, unstandardized care, according to read more >>
September 24th, 2008
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Angiotech Pharmaceuticals Inc. (which despite its name is mostly a device company) announced a read more >>
September 23rd, 2008
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Balloon Sinuplasty, pioneered by Acclarent Inc., is a technology that has come with a lot of hype and a lot of controversy. But now, two studies published in Otolaryngology - Head and Neck Surgery indicate that the technique is safe and effective, according to a company news release. The technology widens constricted sinus passages with specially designed balloons and catheters, and is an alternative to sinus surgery. But there has been much debate in the ENT sector over just how well it works. The studies, which followed 109 patients starting in 2005, reported a 92% rate of functional patency after one year, an 85% rate of improvement in sinus symptoms after two years, and no serious adverse events or worsening sinus conditions. The technique has been used on about 40,000 patients since receiving FDA clearance in...
September 22nd, 2008
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A federal study published Thursday in the New England Journal of Medicine shows that "virtual colonoscopies," which use X-ray technology to detect colorectal cancer, are a viable alternative to regular colonoscopies, highly unpopular with patients. They detected cancer in 9 out of 10 patients whose cancer was confirmed by regular colonoscopies. And so Medicare is considering reimbursement for the procedure, which is cheaper ($300-$800 vs. $3000) and less invasive than regular colonoscopies, reports the Associated Press. Virtual colonoscopies were better at ruling out cancer than at detecting it, so they may be best used as a screening tool to determine who needs a regular colonoscopy, the study authors said. The news could mean that more people now get screened for colorectal cancer. However, radiologists often misread the X-rays to see polyps that weren't there, so a lot of unnecessary...
September 19th, 2008
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FDA's Office of Combination Products is expected to publish two proposed rules by the end of the year, its director said at the Regulatory Affairs Professionals Society annual conference this week. Thinh Nguyen said the topics are good manufacturing practices for combination products and adverse event reporting for combination products. The former has been anticipated by industry for a long time. Device manufacturing is governed by the Quality System Regulation, while pharmaceutical manufacturing is governed by the Good Manufacturing Practices Regulation. The office put out a draft guidance in 2004 about how these should be integrated for combination products, but has not issued any further official word. Nguyen implied that the proposed rule on GMPs won't be too different from the 2004 draft guidance. "When it comes out, you won't be too surprised," he said. "In the meantime, work with us and have patience." The draft guidance states that before the constitutent parts are combined...
September 18th, 2008
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More than 60% of PMA products have condition-of-approval (COA) studies, also called PMA orders, attached to their approval. That means PMA sponsors should not be thinking about whether they will have to perform COA studies, but about what those studies should look like. Otherwise, sponsors could be saddled with studies that gather data just for the sake of it, which is a waste of money. Anthony Blank, vice president of cardiovascular regulatory affairs for Boston Scientific, offered some pointers during a session at the Regulatory Affairs Professionals Society meeting this week. First, he said, the company needs to work with FDA to determine what the key unanswered questions will be at the time of approval. Once those are identified, the sponsor needs to determine what their data requirements are, and whether a COA study is the best way to get that data. "What steps can be taken to maximize data integrity and minimize complexity?" he asked. "How might the data enhance patient care?...
September 18th, 2008
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The Government Accountability Office is preparing a report on whether the 510(k) process is adequate enough to assess the safety and effectiveness of medical devices, and the buzz at the Regulatory Affairs Professionals Society annual conference this week is that it may have some unfavorable conclusions. Some consumer groups and members of Congress have complained that the process is not rigorous enough. "Industry and FDA are unified on the 510(k) process. We believe it works well, is flexible, and is not undemanding," said Patricia Shrader, senior vice president of corporate regulatory and external affairs for Becton Dickinson, who spoke at a session on the FDA Amendments Act of 2007. "But the GAO report may not be entirely positive. And if the GAO says the bar must be raised, then the impact on IVDs may be rather disproportionate." Similarly strong words were uttered by industry and CDRH personnel during the conference's CDRH executive staff briefing. "The majority of products...
September 18th, 2008
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