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Articles from 2008 In April

FDA Under Fire over Blood Substitutes

"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.

Plaque Imaging Device Cleared

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.

Seven-Year Data Shows Coated Catheters Reduce Risk of Bacteria in Blood

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.

First Device Cleared Using Latex Alternative

In 2006, ASTM created a new category for natural rubber latex that specifies safety standards based on protein content.

FDA to Hear from Disgruntled Lasik Patients

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 to Acquire Restore Medical

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. âEURoeMedtronic 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.

Cost Cuts Put Boston Scientific Back in the Black

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.

Nanodevices Being Researched to Diagnose, Treat Cancer

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.

Bill Would Require Country-of-Origin Labels, Permanent Foreign Inspectors

Transforming FDA LogoA 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.

Security Concerns Over Electronic Health Records

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.