CDRH has consolidated its postmarket surveillance guidances into a single document to make it easier to access information. The new document, released today, mostly takes the form of a FAQ. Issues covered include the policy criteria CDRH uses to determine whether to impose postmarket surveillance, the responsibilities of the various review team members, and notification issues. With postmarket issues becoming more of a priority at CDRH, this document should come in handy.
The Heart Rhythm Society, which represents cardiac surgeons who implant heart devices, called for a broad overhaul of how the safety of such devices is monitored, according to the New York Times. Its report, released yesterday, recommends that outside experts be used to help determine when safety alerts should be issued, that more performance data be collected, and that notification of doctors and patients be standardized. These suggestions, it said, could remove financial considerations from deliberations about when to communicate safety issues and commence recalls.Â
We certainly don’t need another Guidant fiasco, and having more voices heard on these matters can only be a positive. But it’s completely unrealistic to expect financial issues to hold no sway. Particularly naive is the statement that “single adverse events that could cause death or serious injuries in patients merit notification” if the problem is likely to recur. It would likely be very difficult to make generalizations based on one event, and it would be even more difficult for the mainstream media to report it with the proper perspective. Media-induced hysteria based on incomplete information would have serious financial consequences for the firm, and that is not something that can be removed from consideration.Â
A study in the Journal of the American Medical Association found significant complication rates — 5.8% of 3000 patients — in procedures to remove implantable cardioverter-defibrillators after they were recalled, the New York Times reports. That raises questions as to whether such surgeries are really needed. What this really highlights is the need to prevent implantations of a model as soon as problems with it are identified. That, not the problems themselves, was the most unseemly part of last year’s Guidant debacle. The company kept selling the problematic models after it was aware of the malfunctions and made improved versions available.
FDA has published a report it commissioned from the Lewin Group that shows industry has serious issues with the implementation of the MDUFMA user fees, and questions whether there has been a real return on the user-fee investment. We already knew this, though. It’s exactly what was said, repeatedly, at last fall’s MDUFMA Stakeholders Meeting. The report is worded much more nicely, of course. But the message is the same: Serious changes must occur when MDUFMA is reauthorized.
Update: The report is back online and can be found here.
Almost immediately after closing its deal to acquire Gudiant Corp., Boston Scientific Corp. found its credit rating cut to barely above junk status by the three major credit rating agencies, the Associated Press wrote in a report available on devicelink.com. The move could make it harder for the firm to borrow money in the future. Moody’s Investors Service, Standard & Poor’s, and Fitch Ratings made the rating cut because of the debt Boston Scientific is taking on to finance the deal, and because of the legal liability it inherits from Guidant over faulty internal cardioverter-defibrillators. We probably won’t be seeing Boston Scientific buying anything else for a while.
The U.S. Federal Trade Commission and the Department of Justice signed off yesterday on what is by far the largest acquisition in device-industry history, the Boston Globe reports. Boston Scientific Corp.’s $27 billion acquisition of Guidant Corp. is expected to formally close today. It will make Boston Scientific the second-largest manufacturer of cardiac-assist devices, an extremely lucrative market. Guidant’s stent business is being sold to Abbott Laboratories, which is paying $4 billion in cash and acquiring $1.4 billion worth of Boston Scientific stock. The FTC is requiring Abbott, whose participation helped alleviate antitrust concerns, to sell the stock within 30 months. Now on tap are some of the most daunting tasks ever faced in the device industry: The first-ever integration of two giant firms, and the placating of CDRH, which has had serious issues with both companies in the past year. Inability to pull off the latter could compromise the firm’s ability to introduce new products.
A women’s health organization is questioning whether an industry-funded study asserting the safety of silicone breast implants drew the proper conclusions. In a release available on devicelink.com, the National Research Center for Women & Families noted that two studies, one funded by silicone maker Dow Corning and one by the National Cancer Institute, both found elevated rates in deaths from respiratory cancer among women with silicone implants. However, the center says, the Dow study attributes the difference to smoking, but the NCI study does not, and it does not rule out implants as a possible cause. The NCI study also found higher rates of suicide for the silicone-implant users. Another study, the center says, found high levels of platinum in the breast milk of women with silicone implants. These findings could make FDA’s pending decisions on silicone implants even more difficult.
It’s first-quarter earnings report time, and the news from a number of device behemoths has been good. Johnson & Johnson reported a 16% increase in earnings over last year’s first quarter, thanks to strong device sales and a payment resulting from its failed bid for Guidant Corp. St. Jude Medical Inc. showed a 15% gain, mainly from strong sales of implantable cardioverter-defibrillators. Abbott Laboratories Inc. saw profits rise 3% despite a (mostly drug-related) decline in sales. And the news was even good for Boston Scientific Corp. despite its reports of a 7% decline in earnings due to slowing drug-eluting stent sales. Its stock price rose because profits exceeded analyst expectations.
The winners of the 2006 Medical Design Excellence Awards can be found in the new issue of MD&DI. A panel of jurors has given awards to 26 products in 10 categories. Gold and Silver designations will be announced at a ceremony on June 7 at the Medical Design & Manufacturing East show in New York City. In the meantime, read MD&DI’s extensive coverage of the winners of this important competition.
This morning’s Boston Globe features a Dutch company’s product that sounds gimmicky but could offer a significant benefit. The Varibel eyeglasses have tiny microphones that serve as hearing aids built in. But they may do a better job than conventional hearing aids of amplifying sounds the user wants to hear and blocking out background noise. That’s because they intensify the sounds coming from the direction that the user is facing, due to their position on his or her face. The product’s not yet on the U.S. market but who knows what kind of reception it could get.
