Edwards Lifesciences announced in a release on devicelink.com that it has introduced the first real-time, continuous central venous oxygenation saturation monitoring technology for critically ill children. The Edwards PediaSat Oximetry Catheter uses fiber optics to monitor and identify potentially life-threatening changes in oxygen saturation in venous blood. Up until now, such technology was only available for adults. But children are even more in need of it, because they sometimes do not display the typical warning signs of potentially fatal issues. Before, physicians had to rely on intermittent blood sampling, which is less reliable and less convenient.
DeviceTalk will return on Tuesday, September 4.
FDA has approved a test that can detect West Nile Virus in donated human blood and plasma. Manufactured by Roche Diagnostics, the test is only one of two on the market that can screen donated blood for the virus. Although most infections are spread via the bite of an infected mosquito, the first transfusion-transmitted infection of the virus was detected in 2003, according to Roche. Most people infected with West Nile don’t get sick either or only have mild symptoms. One advantage to the Cobas TaqScreen West Nile Virus Test is that it can detect the virus earlier in the infection cycle in donors who might not show any symptoms. A similar test made by Gen-Probe Inc. (San Diego) was cleared by FDA in 2005.
In recent years there has been a push to put portable defibrillators in schools. But a study published yesterday suggests that the effort may not be worth the cost, reports the Associated Press. The study looked at emergency response to schools in the Seattle area between 1990 and 2005. Only 12 times during that period did a student suffer cardiac arrest; all other incidents involved adults. The defibrillators tend to cost between $1000 and $3000, not including the cost of training. Some schools have trouble affording that. Schools are required to identify students with health problems who may require an emergency response. The results of that assessment could now form the basis of the decision whether to make the investment in a defibrillator.
The British government is considering a proposal to end reimbursement for drug-eluting stents because of safety concerns, the Associated Press reports. If the policy is adopted, patients would be forced to either settle for bare-metal stents or other treatments, or pay for drug-eluting stents out of their own pockets.
The British and European cardiology societies are fighting the proposal, with good reason. Withdrawing reimbursement would send the message that drug-eluting stents are dangerous devices. The evidence gathered so far does not support that. The move would create panic among patients who already have the devices implanted, and deter most from considering getting them implanted. That’s only appropriate when a device’s risks far outweigh its benefits — which is not the case here.
The University of Chicago Medical Center has hired one of the foremost experts in robotic surgery in an effort to make it more widely available for coronary bypasses, reports the Chicago Tribune. This is another triumph for Intuitive Surgical, which makes the systems. Indeed, the company is supporting the initiative, and believes that a better way to do bypass is increasingly necessary, given recent studies that have identified problems with angioplasty and stenting. (Unfortunately, the company isn’t mentioned until well into the article’s second page.) There is some skepticism about whether robotic surgery is better than conventional surgery when it comes to bypass, and the cases for both sides are made well in the article.
There’s been a whirlwind of activity at Boston Scientific this summer, and it hasn’t all been good. The company is fighting debt and in the past month alone has announced plans to sell three of its entities–its vascular and cardiac surgery units, along with part of Advanced Bionics. In efforts to cut costs, it’s considering making job cuts as well. Now, as Boston Scientific tries to get back on track, it has negotiatied loan agreements and made a $1 billion early loan payment. The prepayment was made on a $5 billion term loan. According to the comapny’s CEO, Jim Tobin, the payment should provide “significant financial flexibility.”
FDA is reviewing more than 300 positions in 20 cities to see whether they could be outsourced to private companies, the Associated Press reports. The original position list included lab technicians and field office workers at facilities where devices are inspected for safety. But it was then revised to include only administrative positions. The National Treasury Employees Union is asking Congress to oppose the plan. And it may succeed; it was lobbying by the NTEU that nixed the agency’s plan to close seven of its 13 field laboratories.
If administrative jobs can be done cheaper and better by the private sector, then the outsourcing plan should be considered. But outsourcing technical people is probably not an avenue that should be traveled.
Medtronic is one of the unquestioned top companies in the device industry. It pioneered cardiac rhythm management and plays in many of the most lucrative device markets. Yet, despite all its successes, its share price has lagged in recent years, because while the firm has shown growth, it has not made the numbers predicted by its executives or Wall Street analysts. The New York Times today has a fascinating look into why clinical success has not translated into stock market success. The article comes as Arthur D. Collins Jr. prepares to step down as CEO tomorrow, handing the reins to William A. Hawkins.
The problems, it seems, are overoptimistic timetables and forecasts, delays in getting new products to market, and slow sales of implanatble cardioverter-defibrillators (partly as a result of publciity about recalls). Indeed, just yesterday Medtronic said that it expects FDA to approve its Endeavor drug-eluting stent by the end of the year. Yet analysts don’t seem to believe that. Also yesterday, Medtronic reported first-quarter income that was more than 12% higher than the same period last year, and revenues 8% higher than a year ago. Yet its share price fell again because it failed to meet analyst estimates. And the analysts don’t make up their estimates out of thin air — they are based on information from the company.
Faith in your company’s outlook is a good thing. But misplaced faith or overoptimism by company executives will not play well on Wall Street. That’s a lesson Hawkins needs to apply immediately.
The government over the weekend announced that Medicare will no longer pay for the extra costs associated with preventable medical errors. The New York Times reports that conditions that will be affected include bedsores, injuries caused by falls, and infections resulting from the prolonged use of catheters in blood vessels or the bladder. CMS also will not pay for the treatment of “serious preventable events” like leaving a sponge in a patient during surgery or providing a patient with incompatible blood or blood products.
In many aspects of life, the best way to deter behavior is to hit those who commit it in the wallet. That’s what CMS is hoping will work here. Private insurers could well follow. If human nature holds true and the new policy prompts fewer misuses of devices and cuts down on other errors, then many lives and dollars could be saved. The healthcare system is vast and slow to change, so it’s not a guarantee that the new policy will achieve its goal, but it’s worth a try.
Titanium oxide-based ceramic nanowires might be a more effective coating for medical devices. Researchers at the University of Arkansas have created the coating for the surface of biocompatible titanium in applications such as hip replacements and vascular stents. Since the length, height, and pore size can be controlled in the nanowire scaffolds, the coating could also prevent implant degradation. The research suggests that the coating could be used in stents to carry drugs that would keep arteries open longer than current drug-eluting stents. When the material is rinsed in water and exposed to UV light, it also kills more than 99% of surface bacteria, making it useful for performing sterilization in hospitals.
