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.
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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.
