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Biomaterials Talk

 
 
Oct
16

The 3rd International Conference on Bioinformatics and Biomedical Engineering (iCBBE2009)
Call for Papers
http://www.icbbe.org/
Beijing, China June 11-13, 2009

Within iCBBE 2009, there are two special sessions:
Special Session 1: Biomedical Imaging
Special Session 2: Biomathematics and Biostatistics
Call for Papers: http://www.icbbe.org/icbbe2009submission/website/icbbe2009/Home.aspx

This conference is sponsored by IEEE Engineering in Medicine and Biology Society (EMBS),
Beijing Institute of Technology and Wuhan University. The conference proceedings will be
published by IEEE. All the papers accepted will be included in the IEEE Xplore and indexed
by EI. For more information, please contact: submit@icbbe.org

Oct
16

Corrosion Testing of Medical Devices: Proving Biocompatibility from Medical Device Daily

When: Thursday, November 6, 2008
Time: 1pm to 2:30pm ET
Cost: $349 per listening site no.
Speakers: Dr. Shari Rosenbloom and Dr. Esra Kus
Duration: 90 Minutes

Before a medical implant device can be sold, the device’s manufacturer must demonstrate that the implant will be biocompatible—it must not adversely affect its host environment (the patient’s body), nor should it be adversely affected by the environment. Corrosion resistance is a key factor in biocompatibility. In this 90-minute audio conference, Dr. Shari Rosenbloom and Dr. Esra Kus will examine the types of corrosion most commonly encountered in medical devices. They will review the FDA’s guidance on in vitro corrosion testing to provide a better understanding of what the FDA is looking for from device manufacturers in demonstrating the corrosion resistance of their devices. They will discuss the various testing methods available, and when each test method should be used. They will show how to design an appropriate testing program, and how to interpret the results of testing. They will also present the lessons learned from experiences with the FDA’s response to results submitted from in vitro corrosion testing.

Learning Points or Questions to Be Answered:

  • Significance of corrosion with regards to device functionality and biocompatibility
  • Different types of corrosion that are relevant to medical implants
  • Typical medical implant alloys and their corrosion properties
  • Perspective on FDA guidance on corrosion
  • Overview of corrosion testing methods — what they are, which tests are appropriate (ISO, ASTM standards)
  • Interpretation of test results, acceptance criteria, and relationship between in vitro testing and in vivo performance
  • Perspective on how the FDA views test results — understanding what the FDA is looking for

Target Audience:
QA/QC professionals
Manufacturing directors, supervisors and staff
Anyone responsible for implantable device testing

Level: Advanced

Registration includes admittance to the 90-minute call for as many people as you can fit in a room with a speakerphone. Access to the specially created presentation handouts (available 48 hours in advance). Participation in the 30-minute, live Q&A with the speaker following the presentation.
Certificates of attendance for all audio conference attendees.

Click here to register. If you prefer to register, or order the CD recording (MP3 format) by phone, then call us at 800-688-2421 or 1-404-262-5474.

Oct
10

The new CMS doesn’t reimburse for nosocomial infections. But the new rules can provide device and diagnostics companies with an opportunity to develop new products that help hospitals eliminate risk. For example, a release from TyRx announced the launch of an implantable cardiodefibrillator that is designed to inhibit surgical site infections.

The AIGISRXâ„¢ ICD is an antibacterial coated mesh envelope developed to help stabilize the implanted device. It also contains the antimicrobial agents rifampin and minocycline. It provides antibiotic protection for about ten days after the procedure. It also helps to stabilize the device in the body.

In the August 19, 2008 Federal Registry, CMS stated that “surgical site infection following certain cardiac device procedures is a strong HAC (hospital-acquired condition) candidate. The condition is high cost and high volume, triggers a higher-paying MS-DRG, and may be considered reasonably preventable through the application of evidence-based guidelines… we expect to propose surgical site infection following certain cardiac device procedures… as future candidate HACs.”

Oct
9

An Ohio State University (Columbus) researcher is designing a hydrogel coating to enhance the longevity of electrical stimulation implants. The coating promotes the integration of nerve tissue with implant electrodes, which could improve the implant’s performance due to better connectivity.

The material has been used for micro­sphere drug release and to make hydrogel tissue mimetics, but not as a prosthesis coating, according to Jessica Winter, assistant professor of chemical and biomolecular engineering at Ohio State. Her team has also been working with different hydrogel materials for antiinflammatory applications but not with neurotropins, proteins that promote neuron survival.

“We’re working on trying to make brain mimetics—materials that look and feel like brain to a surrounding tissue that we could use as coatings on neural electrodes,” says Winter. One of the issues surrounding neuroelectrode implants is the body’s immune response following implantation. A glial capsule can surround the device, causing the neurons very close to it to die. Being able to prevent neural death would enhance the function of those devices.

Winter is specifically looking at the field of deep-brain stimulation, because it’s one of the most successful areas in which brain electrodes are used. Simply applying the coatings to current deep-brain stimulation electrodes could improve their performance.

Another option is to apply the coatings to recording electrodes that are used on epileptic patients to measure the origin of seizures. Current electrodes only last for several months to a year, and this new coating could make them last much longer.

The hydrogels used in the coating are crosslinked polymers that are hydrophilic but not water-soluble. “They’re about 90–99% water. The particular polymers that we’re using are PEG [polyethylene glycol] hydroxy acids,” says Winter. “That includes lactic acids, glycolic acid, and caprolactone.”

PEG provides biocompatibility and has been widely used in the medical industry to enhance the circulation time of drugs and to coat implants. It’s also known to resist protein absorption and can prevent an immune response. The advantage of using lactic acid is that it’s natural, so there are fewer concerns about a negative interaction with the body. The hydroxy acid component was chosen because it is degradable over time and would enable a mechanism to tune drug release.

The researchers regulate the thickness of the coating by drop casting it onto the devices. Its thickness, which is controlled by surface tension, measures several hundred µm. They also patterned the coating to improve its thickness. Although most of the coatings have been 30–40 µm thick, Winter says they can be made thinner if necessary.

The team is trying to improve its release time from three weeks to about eight weeks. Winter would like to switch from using lactic acid to caprolactylic acid, because it degrades at a slower rate, which would extend drug release.

They’re also exploring composites that can consist of hydrogels and other materials such as microspheres and electrospun fibers. The microspheres are made from polylactic coglycolic acid, and the electrospun nanofibers are composed from polycaprolactones, which is another hydroxy acid. The composite materials could help them achieve a more linear release profile.
Winter and her team recently presented their research, which is being funded by Ohio State, at an American Chemical Society meeting in Philadelphia.
—Maria Fontanazza

Oct
1

The plastics processing industry now has a new information resource and web community called plasticstoday.com, announced by Canon Communications LLC’s Plastics & Processing Group during the gathering of plastics professionals at the PLASTEC / Plastics USA 2008 trade show on September 23 - 25, 2008.

Extending from the two top magazines, Injection Molding Magazine (IMM) and Modern Plastics Worldwide (MPW), and their related Web sites, plasticstoday.com provides a global online community for plastics professionals that fosters solutions through interactivity.

Oct
1

Editor Steven M. Kurtz has announced the launch of MedicalPEEK.org, an educational site about medical PEEK polymer

Polyetheretherketone (PEEK) polymers are used in medical devices requiring implantation or blood, bone and tissue contact greater than 30 days. Used in spinal fusion for more than a decade, interest in this advanced and versatile polymer continues to grow.

Kurtz serves as the founding editor for the site, which is designed as a lexicon reference for medical PEEK and targeted toward materials- and bioengineers, medical device designers, surgeons, academics, scientists and other medical, and medical device industry professionals.

With interest in implantable PEEK continuing to grow across diverse medical applications, Kurtz said in a press relase that he expects site visits to mirror that trend.