Migraine headaches are an extremely difficult condition to live with, and treatment options are limited to taking large doses of pain medication at onset. NMT Medical of Boston has been trying to see if its implantable heart device, the StarFlex, can prevent them. Results presented yesterday at the American College of Cardiology meeting were mixed, according to the New York Times .
The American College of Cardiology meeting is an event where the latest cardiovascular studies are presented, sometimes revealing a bombshell. But that didn't happen this year, at least in the ongoing battle between Johnson & Johnson's Cypher and Boston Scientific Corp.'s Taxus for the lucrative drug-eluting stent market. Bloomberg News reports that the research presented at ACC over the weekend doesn't give an advantage to either product.
Bloomberg News is reporting that President Bush may nominate Acting FDA Commssioner Andrew von Eschenbach to the post permanently in as soon as a few weeks. Congress has been clamoring for a permanent leader to spearhead upcoming agency reforms. And by law, the president must nominate a permanent commissioner after an acting one has been sitting for 210 days. The device industry has a favorable impression of von Eschenbach, and his appointment would give FDA some much-needed stability and leadership.
The nanotechnology revolution is underway, but expect it to proceed slowly. This morning's Washington Post reports on a survey of nanotech usages. Of more interest, though, is the second half of the article, which discusses safety issues. Specifically, too little is known about them, and some companies have been reluctant to let the government do testing and evaluation. That's not an option with medical device applications, of course.
Further evidence that the Guidant name might be permanently scarred emerged in this morning's New York Times . The paper reports that a consultant working for Guidant urged the company to tell doctors about heart device defects and overhaul its data-disclosure policies. The consultant, Dr. Richard N. Fogoros, told Guidant that it had an ethical obligation to be forthright with physicians, and erred by substituting its medical judgment for theirs.
After it is sold to Boston Scientific Corp., Guidant Corp.'s name will disappear forever. According to Bloomberg News , the heart-rhythm unit of the combined company will be called Boston Scientific Cardiac Rhythm Management. CFO Larry Best announced the change at an investor conference yesterday. The move is understandable, given the negative publicity surrounding Guidant products and the fierce competition for the CRM market with Medtronic Inc. and St. Jude Medical Inc.
For the device industry to maintain credibility with the public, it must show an overt commitment to ethical practices. AdvaMed's new Code of Ethics Self-Certification Program should help. Unveiled at the trade organization's annual meeting last week, the program grants licenses to qualifying companies to display a logo showing they comply with AdvaMed's Code of Ethics . Companies must certify that they meet all eight elements of a "condition of use" agreement.
When CDRH Director Daniel Schultz addressed the AdvaMed annual meeting last week, everyone expected a presentation heavy on postmarket issues. He did not disappoint.
One of the most debated topics at last week's AdvaMed annual meeting was the publicity hit the device industry has taken from some high-profile recalls and adverse events in the past year. Humphrey Taylor, chairman of The Harris Poll , presented a poll showing that about 70% of consumers think medical technology companies do a good job of serving their customers. Their work has created an almost uniformly positive impression, and the value their products bring is appreciated.
MD&DI editor-in-chief Erik Swain is at the AdvaMed annual meeting today. As the dominant industry organization, it carries a lot of weight and draws some of the biggest movers and shakers as speakers. Watch this blog in the next few days, because Erik will be giving you an insider's view of the conference, including his take on the the comments of CMS administrator Mark McClellan and former HHS Secretary Tommy Thompson.
Over 30 organizations, including AdvaMed and the National Electrical Manufacturers Association (NEMA), have sent a letter to Congress decrying cuts made in medical imaging services for Medicare recipients. The cuts were part of the Deficit Reduction Omnibus Reconciliation Act of 2005. Particularly troubling is that the cuts were inserted into the bill without any public debate in either house of Congress. The letter also maintained that no analysis had been performed and thus there could be unintended consequences.
Here's a nice article from the Cleveland Plain Dealer about an implantedÂ prosthesis that treats the painful symptoms of lumbar spinal stenosis. Before the X-Stop prosthesis got FDA approval in November, the standard of care was steroid injections, which are wrought with potential side effects. What's not so nice about the article is that it makes no mention of the device's manufacturer. (It's St. Francis Medical Technologies Inc.
Conglomerate Tyco International Ltd.'s plan to split into three companies got a boost when a group of shareholders said they would drop a federal lawsuit seeking to block the breakup. According to the Associated Press , the shareholders wanted to ensure their recovery rights from a potential settlement in a securities fraud case. They have been assured that the three new companies will share the liability.
Many of you are probably familiar by now with the saga involving Indianapolis-based Guidant Corp.'s defective heart devices. But the public is about to get a whole lot more familiar with it. Some of the company's internal documents have been made public, and theyÂ seem to showÂ that Guidant executives may have been more familiar with the problems than they had let on.
Amid the recent spate of bad press, itâ€™s good to see that not all of the coverage is negative. An AP story in major newspapers today focuses on the advances being made in neuromodulation devices. Itâ€™s a story about the struggles of Don Falk, a patient who suffered from uncontrollable tremors caused by advanced Parkinson's diseaseâ€”that is, until he had deep brain stimulator implanted.