FDA approved trials involving artificial blood substitutes even after studies showed the products elevated the risk of heart attack and death, an NIH analysis found. Research as early as 2000 found that patients using the products were as much as 30% more likely to have a heart attack or die, yet FDA continued to approve clinical trials for them, the Washington Post reports.
FDA says it weighed the risks and benefits of each study individually. “We have made careful decisions about allowing some studies to proceed and others not to proceed,” said Jay S. Epstein, director of the Office of Blood Research and Review. “Our point of view is that FDA has been highly vigilant in its oversight.” The agency has yet to approve a blood substitute because of toxicity concerns.
CDRH has cleared for marketing a device that can enable a doctor to look inside a blood vessel to assess the makeup of the plaque in the coronary artery. The LipiScan NIR Catheter Imaging System, made by InfraReDx Inc., can allow doctors to determine the fat content of the plaque. It does this via near-infrared imaging. This, in turn, can help doctors determine whether the plaque is at risk of rupturing.
Recent research has shown that it is not the amount of plaque in the arteries that determines whether a patient is going to have a heart attack, but whether or not the plaque is “vulnerable,” or at risk of rupturing. It will be very important to determine how plaques that are prone to rupture can best be identified before they cause a heart attack, and such research is underway. But the amount of fat in the plaque may be an indicator. Studies of patients who died from heart attacks have identified a large lipid (fatty) core among features of coronary artery disease that were associated with plaque rupture and blood clots.
So it’s possible that the LipiScan will be able to help determine who is at risk for a heart attack, which would make its clearance a very significant moment in medical history. The device works by placing a catheter equipped with a fiber-optic laser light into the artery. The device shines the near infrared light delivered through the blood to the artery wall, and measures the light reflected back from the artery wall, a technique called spectroscopy. The reflected wavelengths vary depending on how much fat and other substances are in the plaque in the illuminated portion of the wall.
An infectious disease physician presented seven-year data showing that coating central venous catheters with antibiotics minocycline and rifampin reduces the risk of bacteria getting into the blood. The data also showed no proof that the antibiotics promote resistance to bacteria, which some researchers had been concerned about. Issam Raad of the University of Texas M.D. Anderson Cancer Center presented his findings at the 18th annual scientific conference of the Society for Healthcare Epidemology of America.
This could be a significant step in preventing catheter-related infections, which are responsible for 250 deaths each day in the United States. It is also good news for Cook Medical, which makes catheters coated with the antibiotics studied. Dr. Raad is the co-inventor of that pairing, and receives royalties from Cook.
In other infection-control news, a study showed that for three kinds of surgery, laparoscopic procedures reduce the risk of hospital-acquired infections by 52%, and of readmission by 65%, as compared to open surgery. The study, conducted by Ethicon Endo-Surgery and presented at the Society of American Gastrointestinal and Endoscopic Surgeons annual meeting, looked at hysterectomies, appendectomies, and gallbladder removals. It is the first study to look infections related to these procedures up to 30 days after discharge. It points to the benefits minimally invasive surgery can have in terms of patient care and keeping healthcare costs down.
FDA has cleared the first device, an exam glove, made from natural rubber latex. This provides an alternative for the 3% to 22% of healthcare workers who are sensitive to traditional latex. The Yulex Patient Examination Glove is made from guayule latex, which comes from a desert bush found in the southwestern U.S., called the guayule bush. Arizona-based Yulex Corp. manufactures the glove and has been working on getting a safer alternative into the market for several years. In 2006, ASTM created a new category for natural rubber latex that specifies safety standards based on protein content.
FDA’s ophthalmic devices panel will consider complaints about laser vision correction surgery, the Associated Press reports. At its meeting tomorrow, the panel will hear from patients who have had problems as a result of the surgery, as well as from the American Society of Cataract and Refractive Surgery, which says 95% of patients who have the procedure are satisfied with the results. The agency will ask the panel whether educational materials given to patients need to be changed, to better inform them of the risks. Between 1998, when the devices were first approved, and 2006, the agency received 140 complaints from patients. A large-scale study of patients’ quality of life after the surgery has not been done, but the ASCRS will begin work on one soon.
If negative publicity emerges from this, it could impact Advanced Medical Optics, Alcon, and Bausch & Lomb, which are the largest players in the laser vision correction devices market.
UPDATE: Addressing complaints about Lasik and assessing the quality of life after Lasik surgery will be one of CDRH’s biggest priorities in the near future, said Daniel Schultz, CDRH director.
UPDATE 2: The panel suggested that FDA strengthen its warnings on the procedure and add more information to its Web site regarding who is not a good candidate for the surgery. The panel said there was nothing wrong with the technology itself.
Medtronic announced that it will pay $1.60 per share, or about $29 million, to buy Restore Medical, a former MD&DI Medical Manufacturer of the Year. Restore makes a treatment for mild and moderate sleep apnea called the Pillar Procedure. It treats the fluttering of the soft palate, which is the cause of some cases of sleep apnea. Three small implants made of polyethylene terephthalate yarns are inserted into the roof of the mouth to stiffen the soft palate.
Restore will be incorporated into Medtronic’s ENT business. “Medtronic can quickly leverage its distribution and marketing strengths to improve patient and surgeon access to this minimally invasive therapy,” said Bob Blankemeyer, president of the ENT business at Medtronic.
The Pillar Procedure had not caught on as much as it deserved to, and Restore had gone into debt because of that. With Medtronic’s marketing muscle now behind it, the technology’s fortunes should vastly improve, and more patients should benefit.
UPDATE: Medtronic has completed the purchase and cut 37 jobs. Many of Restore’s other employees had already resigned. Medtronic will keep the sales force, and have a few others stay on temporarily as consultants. Those whose jobs are getting cut will be offered severance packages.
Boston Scientific showed a profit in the first quarter after two consecutive quarters of losses, reports the Associated Press. But sales of its two main product lines, stents and implantable cardioverter-defibrillators, have continued to be sluggish. The main reason for the profit: cost cutting. In the last half-year, the firm has shed 2300 jobs and sold off some of its businesses. Fruits from those moves are now starting to show up on the bottom line. Analysts remain concerned that the firm’s “fundamentals remain depressed,” however. The company earned $322 million in the first quarter, compared to a profit of $120 million the same period a year ago. Quarterly sales were $2.05 billion, down from $2.09 billion in the first quarter of 2007.
In other earnings news, Kinetic Concepts Inc. saw a 27% jump in profit, thanks to strong overseas sales and the weak dollar. The firm earned $68 million in the first quarter, up from $53.6 million the same period a year ago. Sales rose 14%, from $368.8 million to $420 million.
A lengthy article in the Boston Globe looks at some of the research going on with nanodevices, particularly in how they may be used to diagnose and treat cancer. The federal government has given $145 million in grants in this area. One project is using iron oxide nanoparticles as a diagnostic tool: If the particles are absorbed into the lymph node, that’s an indicator as to whether cancer is present. Another is using the same material as a drug delivery device. When nanodelivery of cancer drugs becomes a reality, it will make today’s chemotherapy regimens seem barbaric.
This kind of research is probably not news to most of you. We have covered it in MD&DI, and much has been written about it in scientific journals. But it is nice to see it getting notice in the mainstream media, beyond the scientific and engineering communities.
A bill proposed in the House of Representatives would require all medical devices being imported into the United States to be labeled with their country of origin, reports the Associated Press. The bill would also create a permanent foreign-inspection staff for FDA and mandate that overseas device and drug plants be inspected every two years. These measures are spurred by a slew of recent reports about tainted products from China, including a recall of heparin, which is used as a medical device coating.
Also of significance is that the bill contains language that gives FDA the power to force recalls. Currently, they can only suggest that a manufacturer conduct a recall. The vast majority of the time, the manufacturer complies.
As some manufacturers of new technologies promote interoperability with electronic health records, they need to consider patient privacy. An article in The New England Journal of Medicine raises concerns over the security of information contained in electronic records that would be maintained by companies like Microsoft or Google. The authors state that such companies aren’t bound by the privacy restrictions set forth by the Health Insurance Portability and Accountability Act (Hipaa). Passed more than 10 years ago, Hipaa didn’t foresee Web-based health records as an issue. The authors of the journal article, who are also proponents of electronic patient records, suggest safeguards that combine federal regulation with contract relationships, and other standards and education programs.
