From DeviceTalk Blog:
A study funded by C.R. Bard has found that if ventilator tubes are coated with silver, the risk of gravely ill patients catching pneumonia is reduced by 36%, Reuters reports. Bacterial pneumonia is one of the most insidious hospital-acquired conditions, and patients can get it from infections caused by ventilator tubes. Half of the antibiotics used in hospital intensive care units are prescribed to help prevent bacterial pneumonia in patients put on ventilators. Silver is widely used as an antimicrobial agent and has been shown to reduce bacterial pneumonia infections in animals. So Bard wanted to see if a silver coating would help reduce the infections in humans. The study tested the coated tubes between 2002 and 2006 on 1500 patients expected to be placed on a ventilator for more than 24 hours. When all was said and done, 4.8% of those with silver-coated tubes developed ventilator-associated pneumonia, compared with 7.5% of patients who were on ventilators with uncoated tubes. The coating also appears to have delayed the onset of pneumonia in the patients who did contract it. There was no impact on death rates, however.
Kudos to Bard for stepping up to the plate to enable these findings to come to light. Ventilator makers should start using coatings on their tubes, if they haven’t already.
—Erik Swain
Reuters reports that Rensselaer Polytechnic Institute has created tiny amounts of a synthetic version of heparin. The researcher hope it will avoid the risk of contamination, blamed for the death of more than 80 U.S. patients earlier this year.Only milligram doses of the product have been made so far, but they are already working on ways to expand production to kilograms.
Bringing the production of the drug, which is currently harvested from pigs, to the pharmaceutical lab would ease fears of contamination.
From FDA News:
Watson Pharmaceuticals is voluntarily recalling one lot of 75 mcg/hr fentanyl transdermal system patches sold in the U.S. from wholesalers and pharmacies.
A small number of patches leaking fentanyl gel have been detected in this lot, which may expose people directly to the gel and lead to serious adverse events such as respiratory depression or possible overdose.
The affected patches were shipped to customers between Jan. 30 and March 19. No other strengths or lots were affected, and the company does not anticipate any product shortages as a result of this recall. The company has notified the FDA, Watson said.
Its not exactly a biomaterial, in fact, its barely even usable right now, but graphene could change the way medical implants are designed. Never heard of it, you say? Graphene is a hexagonal carbon supermaterial that makes up graphite (you know, as in pencils). It was isolated in 2004. The material is characterized by a large surface-to-volume ratio and high conductivity, suggesting it could be used in ultra-small electronics. Research has demonstrated that atom-thick transistors can be created using graphene in place of silicon.
New research has claimed it is the strongest material measured, and only a portion of its properties have been discovered. Its safe to say that graphene is a bit of the newest geek-out material.
“There is no doubt in my mind that these structures can be used for technological applications,” Antonio Castro Neto of Boston University says. “The electronic flexibility and structural stability, fundamental for modern device development, are unmatched in any other material on Earth.” But working out how to manufacture graphene devices on a practical scale remains a challenge, he concludes.
Once electronic chips can be made at nanometer scale it only a matter of time before medical implant manufacturers are using such chips in their designs. It may even change the way implants are designed, since initial research indicates graphene may raise fewer toxicity concerns than other nanomaterials.
There are a few problems with graphene. At this point, for example, it is incredibly difficult to get flakes in a workable size. In addition, graphene sheets tend to curl up and react with substances around them, making them difficult to build into devices. Stay tuned, however, as the research matures.
Great video that was posted last month about how biomaterials science is driving nanotechnology. Ogan Gurel interviews Chad Mirkin, PhD who is a professor of and Northwestern, as well as the Director of the Institute of Nanotechnology.
The main way the development is working is by focusing on interdisciplinary efforts. Its a bit like herding cats, joked Mirkin. The interview is about 15 minutes long and hass commercials, but its got some really strong information.
FDA News reports that manufacturers of coronary drug-eluting stents should provide the results of biocompatibility tests of the bare-stent platform. The edict comes from a final guidance by the European Medicines Agency’s (EMEA) Committee on Human Medicinal Products.
According to the committee, biocompatibility test results for all relevant materials, including carrier and stent material, must be submitted to the national competent authorities and the EMEA, and firms should document the extent to which testing conforms to ISO 10993.
The guidance becomes effective Dec. 1. It covers the clinical and nonclinical aspects of the assessment of ancillary medicinal substances contained in drug-eluting stents. It describes a range of drug-device situations and the data required to adequately evaluate the drugs contained in the stent.
“Guideline on the Clinical and Non Clinical Evaluation During the Consultation Procedure on Medicinal Substances Contained in Drug-Eluting (Medicinal Substance-Eluting) Coronary Stents” is available at www.emea.europa.eu/pdfs/human/ewp/11054007enfin.pdf.
In 2003 Boston Scientific received 510(k) clearance for guglielmi detachable coils for the treatment of certain high-risk types of brain aneurysms. The product was different in that the coils were coated with a bioabsorbable copolymer which has been shown to decrease aneurysm size, among other attributes. Use of coated coils for aneurysm treatment is on the rise, says a report from Research and Markets called “Endovascular Cerebral Aneurysm Repair Market.”
In it, the report says that the introduction of biomaterial coating options platinum wire significantly responsible for the expanding the market, which has been growing at an average compound annual rate of 22% over the past five years.
The market for the endovascular treatment of cerebral aneurysms stands at US$660 million globally and is expected to double over the next seven years.
High axial myopia, or extreme nearsightedness, is one of the world’s leading causes of blindness. The condition stems from weakness in the sclera, the eyeball’s white outer wall, which causes it to deform even under normal pressure within the eyeball. Researchers at UC Berkeley College of Engineering are developing a new treatment for the condition, based on a synthetic hydrogel.
Treatment for the cause of myopia involves strengthening the eyeball against internal pressure so that it resists elongation. One experimental treatment, which originated in Russia decades ago, involves suturing reinforcing strips around the back of the eyeball, which act like rubber bands pushing the sclera forward. These “scleral bands” are typically made out of donated eye tissue, which is scarce, or Teflon, which can cut into the eyeball underneath. Either way, sewing them on is a delicate and risky operation.
Berkeley researchers think they can simplfy treatment using a biodegradable “functionalized biomimetic hydrogel” that is liquid at cool temperatures, and becomes a soft rubber-like solid at body temperature. The surgical procedure is currently undergoing animal testing. The gel conforms to the shape of the eye wall, then warms up and stiffens, adding strength. Because the hydrogel never enters the vitreous humor or touches the cornea, the procedure is safer and less invasive than the existing operation.
Click here for the full story.
Kensey Nash said in June that the company is estimating Biomaterial product sales of $13.0 to $13.2 million, an increase of 34% to 36% over biomaterials product sales for the same quarter a year earlier.
Yeah, its just a little nugget of info, but I think we’ll see similar announcements in the next few years.
A report analyzes the worldwide markets for biocompatible materials. The specific product segments analyzed include polymeric materials, metallic materials, and natural materials.
The report provides separate comprehensive analytics for North America, Japan, Europe, and Rest of World. Annual forecasts are provided for each region and product segment for the period of 2000 through 2015. The report profiles 70 companies including many key and niche players worldwide.
Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
