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FDA Issues Notices on RF Ablation Devices, Dental Handpieces

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 dental handpieces. If they are poorly maintained, they may not send any signals about, for example, the bur being too dull or the gears being worn or clogged. Instead, they will send increased power to the handpiece to make up for sluggish performance. This can generate too much heat, leading to patient burns. The agency suggests that practitioners check for worn drills or burs before use, properly maintain their handpieces in accordance with manufacturer recommendations, train personnel to properly clean and maintain them, and not use poorly maintained devices.

Will Xience Dominate DES Market?

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 data showing that Xience/Promus is safer and more effective than Taxus. "At the end of the day, clinical data and performance drive long-term utilization," he said, and those factors will likely point to Xience/Promus taking over market leadership. (If this is true, it means J&J's direct-to-consumer ads for Cypher will prove almost meaningless.) So why hasn't Boston Scientific switched its marketing focus to Promus internationally? (Obviously it wouldn't consider making such a switch in the US until Xience/Promus receives FDA approval.) We don't know for sure, because there was no one from the firm on the panel. But it's probably because under the terms of the Guidant deal in which Abbott got the rights to Xience, Abbott is entitled to 40% of the revenues from Promus. The audio from the panel discussion is archived here.

FDA OKs Zimmer Mobile Bearing Knee

Inhaled Insulin Patent Dispute Settled

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.

Shoulder Replacements Becoming More Popular

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.

Edwards Lifesciences to Sell LifeStent to Bard

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.

Reactor Issue Could Halt Imaging Tests

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 pushing through legislation that would reopen the reactor. UPDATE 2: The reactor has been reopened.

Supreme Court Hears Medtronic Case

But Medtronic and the industry associations who have intervened on its behalf argue that the PMA process is much more thorough, and that for state courts to undermine FDA's authority to ultimately determine safety and effectiveness would throw the whole system into chaos. Specifically at issue is wording from the Medical Device Amendments Act of 1976, which does not allow states to impose on manufacturers "any requirement which is different from, or in addition to, any requirement applicable under this chapter." Since 1992, the high court has interpreted the word "requirement" to include damage awards by state courts. "Allowing states to serve as secondary regulatory bodies would undermine the established science-based review process in place for medical devices and diagnostics and slow down patient access to these life-saving and live enhancing products," said AdvaMed General Counsel Christopher White in a statement released by the trade group. The plaintiff's attorney argued that premarket approval is a preliminary judgment of safety and effectiveness, not an ultimate one, and so manufacturers should not be relieved of any obligations to make their products better.

Cordis Takes Cypher to the Public

The best theories: to counter the negative publicity drug-eluting stents have received over the past year and a half, especially now that new data to counter it has come to light, and to keep Cypher fresh in potential patients' minds once two new competitors, Abbott's Xience and Medtronic's Endeavor, hit the market. J&J's chief medical officer tells the Times that in so many words. Both new competitors should be on the market by the second quarter of next year. The ad has come under some criticism, however. The Times calls it "mystifyingly vague" and quotes a doctor who is against direct-to-consumer advertising for drugs and devices. But the article does acknowledge that it is impossible to explain what a drug-eluting stent does in 60 seconds, so perhaps the best course is to refer patients to their doctors. Will it work? We'll see, but an effort earlier this year by Medtronic to promote its implantable defibrillators directly to the public didn't, really.

Diagnostics Reimbursement Reform Bill Introduced

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 (R-NJ), Mike Thompson (D-CA), and Phil English (R-PA), sounds like a great idea. It could counter some of the shortsighted legislation passed in recent years that has restricted access to diagnostics.