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Articles from 2009 In February


FDA Examines BPA in Medical Devices

A common chemical found in many polycarbonates and epoxy resins, Bisphenol A (BPA) is no stranger to controversy. In the past several years, BPA has been the subject of intense scrutiny stemming from reports of it leaching out of such products as aluminum cans and baby bottles. Toxicity experts have expressed "some concern" about exposure of children and infants to BPA. In light of this concern, FDA is now turning its attention to whether BPA-containing plastic parts used in medical devices may be leaching the controversial chemical into patients during certain procedures. The organization has launched two studies to investigate the matter and presented its plan to FDA's Science Board earlier this week. Previous studies have indicated that BPA mimics female reproductive hormones and could contribute to such afflictions as cardiovascular disease, diabetes, and liver problems. In an effort to evaluate the potential toxicity of BPA in medical devices, the studies will attempt to measure BPA exposure of pediatric patients receiving cardiopulmonary bypass and patients undergoing hemodialysis. These procedures were selected because patients are exposed to the chemical for long periods of time. Furthermore, BPA has been shown to leach when heated—a potential hazard in such procedures because warm blood passes through the plastic tubing and then recirculates in patients' bodies. FDA will assess the risks and benefits on a case-by-case basis of BPA leaching from medical devices if data reveals that exposure exceeded FDA's "tolerable" level. MedPage Today has an interesting on-camera interview with Jonathan Sackner-Bernstein, MD, of FDA explaining the study. BPA-free baby bottles are currently all the rage. Are BPA-free medical devices next?

Silk Worms Its Way into Reconstructive and Plastic Surgery

Serica Technologies Inc. (Medford, MA) has received 510(k) clearance from the FDA for its SeriScaffold technology, a silk-based biomaterial developed for tissue regeneration. A bioengineered material for soft-tissue repair applications, SeriScaffold has the potential to serve as an off-the-shelf bioresorbable support for the long-term repair of weakened or damaged connective tissue, according to the manufacturer. For the approximately 60,000 women each year who undergo reconstructive surgery following such illnesses as breast cancer, the material could be used for sophisticated tissue repair. Serica's grafts for anterior cruciate ligament repair, surgical meshes, and gels are composed of fiber protein from the B. mori silkworm. Preclinical studies have demonstrated that the company's silk-based products bioresorb at slower rates than other common structural proteins such as collagen and other water-soluble synthetic polymers, optimizing the healing process. In addition, the silk-based biomaterials do not require rehydration or advance preparation before surgical implantation, according to the company. SeriScaffold also provides a natural protein-based alternative to synthetic materials and graft products harvested from human or animal cadaver tissue. "Major challenges still exist for both surgeons and patients faced with breast reconstruction and other forms of plastic and reconstructive surgery," explains John E. Gross, associate professor of surgery at the University of Southern California Keck School of Medicine (Los Angeles). In many types of breast surgeries following mastectomy, mastopexy, or body contouring procedures, scaffolding is needed to support a geometrically complex implantation site at the time of surgery and provide the time and structure necessary for optimal healing. "A silk-based scaffold that supports immediate tissue infiltration and maintains its integrity over a longer term, as it is being bioresorbed by the body, may be significant in addressing these clinical needs," remarks Gross. Gregory H. Altman, president and CEO of Serica Technologies, states, "We plan to leverage the well-known physical properties of silk in additional surgical applications and will be initiating new clinical studies using our novel technology." The company's goal, he adds, is to develop a portfolio of tailored scaffold products to be available in many contoured shapes and sizes for patients undergoing breast reconstruction or augmentation. Altman believes that the technology has applications for a range of necessary procedures for patients requiring reconstructive plastic surgery, as well as for patients undergoing elective and other forms of soft-tissue repair surgery. Hence, the company is planning additional R&D to determine how SeriScaffold can be used in aesthetic augmentation and reconstructive surgical procedures. The silk-based material is also showing promise in other areas, including rotator cuff and hernia-repair surgeries. "Serica is actively seeking a strategic partner to advance the SeriScaffold product array, particularly in the aesthetic and reconstructive surgery market," notes Altman. At the same time, the company is continuing to advance its ligament and tendon platform technology in the orthopaedic marketplace.

Accel Plastics Acquires Elixir Assets

Plastics processing services provider Accel Plastics Inc. (Auburn, WA) has acquired the assets of now-closed Elixir Industries, Custom Thermoformed Plastics division (Vancouver, WA). Assisted by Stopol Business Services, the merger and acquisition consulting arm of plastic processing equipment supplier Stopol Inc. (Solon, OH), Accel now owns Elixir's book of business, including sales records, files, and tooling so that Accel can support Elixir's former customer base. Elixir closed its Vancouver facility at the end of January due to declining sales. Elixir's custom design and pressure and vacuum forming capabilities blend well with Accel's range of services, which includes moldmaking, CAD/CAM, prototyping, die cutting, welding, and assembly, in addition to pressure and vacuum forming and product and tool design. Having provided these services to the medical and electronics industries for more than 20 years, Accel is using this acquisition to diversify and grow its business, despite the ailing economy. This deal has the potential to increase Accel's sales numbers by as much as 20 percent, according to the company. It expects that the industry will see more examples of such consolidation transactions because some smaller operations are unable to sustain themselves in the current economy. In addition to providing auction, liquidation, M&A consulting, and financing services, Stopol supplies injection, blow, and rotational molding equipment, as well as thermoforming, extrusion, and other machinery. Its knowledge of the plastics industry made it uniquely qualified to assist Accel with the acquisition.

Medtronic Acquires Two for Big Bucks

The next-largest is the $525 million acquisition of St. Francis Medical Technologies Inc. by Kyphon Inc. in January 2007, with an additional $200 million in potential milestone payments. In addition, Medtronic also agreed to pay $325 million up-front for an Israeli company, Ventor Technologies Ltd., which had raised $17 million in venture financing. Both Ventor and CoreValve develop replacement aortic valve systems. CoreValve specializes in heart valves that don't require chest surgery for insertion.

MRI Redesign Could Improve User Experience

An antenna interacts with the sample via a travelling electromagnetic wave. Its magnetic component B excites nuclear oscillations and receives the resonance signals. Image credit: Swiss Federal Institute of Technology Zurich.

An antenna interacts with the sample via a travelling electromagnetic wave. Its magnetic component B excites nuclear oscillations and receives the resonance signals. Image credit: Swiss Federal Institute of Technology Zurich.

Patients suffering from claustrophobia rejoice: a new MRI design may enable a more-comfortable user experience. Conventional MRI designs rely on near-field coupling, which requires that the detector is as close to the subject as possible, hence the narrow claustrophobia-inducing tube. MRI scanners also employ stationary radiofrequency fields to excite magnetic resonance in hydrogen nuclei in order to obtain the desired image. However, a team of Swiss researchers has developed a new approach to capturing images that has radiofrequency waves on the move. Rather than using stationary radiofrequency fields for MRI, the Swiss scientists adopted the use of traveling radiofrequency waves. A magnet lined with a conductive material served as a suitable waveguide for efficient signal transmission while an antenna generated propagating waves that penetrated the imaging sample and recorded resonance signals. This method produced magnetic resonance images of larger parts of the body more uniformly than was previously possible, according to the team. Furthermore, the technique enabled signal reception across distances in the meter range, which would allow for more-spacious MRI designs. "The fact that MRI signals can be received with an antenna and across such large distances is remarkable; it‘s a paradigm shift," says Klaas Prüssmann, a professor at the Institute of Biomedical Engineering of the ETH Zurich and one of the researchers. He adds, however, that despite the progress, there are still hurdles to clear before the new imaging method could be having MRI patients breathing easier. "Unfortunately, the cost of the strong magnets is still substantial and the clinical benefits of very high fields first need to be proven in extensive studies," he says.

Iraq War Veteran Wants to Revolutionize Prosthetics

A slideshow in IEEE Spectrum online features Kuniholm in his journey for better prosthetics. He also started the Open Prosthetics Project, an online group that facilitates open discussion of design ideas for the devices and promotes open standards. In an article that is scheduled to appear in the March issue of IEEE Spectrum, Kuniholm will discuss how developing the next generation of prosthetic arms can pull from the creativity found in gaming technology such as Guitar Hero.

Diamonds: A Heart Pump's Best Friend

A heart probe. The black material on the cage is the diamond coating.

The inflow opening of an infant-size Jarvik blood pump. The black material on the cage is the diamond coating.

Advanced Diamond Technologies Inc. (ADT) has agreed to supply diamond coatings to Jarvik Heart Inc. (JHI) to improve the blood contacting surfaces of heart pumps that are currently under development. Known as UNCD, the thin and smooth diamond surface inhibits the formation of blood clots inside the heart pumps and reduces the need for blood-thinning medications. In some patients, blood clots can form on the titanium or ceramic components used in heart pumps such as rotors and bearings, inhibiting the devices' ability to pump blood. In extreme cases, blood clots can break free, travel to the brain, and cause strokes. "Presently, blood-thinning drugs are used with all types of electric rotary blood pumps," notes Robert Jarvik, president and CEO of JHI. "If the UNCD coating successfully eliminates the formation of blood clots without the need for anticoagulation, this would solve one of the remaining barriers to the widespread use of heart-assist devices in tens of thousands of patients dying of heart failure." ADT's president Neil Kane states that the processes employed to manufacture UNCD for industrial applications were applicable and transferable to heart pumps. He adds that his company is beginning to explore untapped commercial applications for UNCD, including artificial heart valves, cardiac stents, and other metal and ceramic components of intravascular prostheses. Because the flow channels of heart pumps for infants and children are so tiny, the risk of blood clotting is even higher with these devices than with pumps used for adults. Under a contract from the National Institutes of Health, JHI is developing small heart pumps incorporating UNCD, which are expected to save children's lives in the future.

Ironing Out Assembly at the Nanoscale

A magnetic solution enabled the self-assembly of complex nanostructures. Image credit: Duke University.

A magnetic solution enabled the self-assembly of complex nanostructures. Image credit: Duke University.

Magnetic attraction may be the key to sophisticated self-assembling nanostructures, according to researchers at Duke University and the University of Massachusetts. Although scientists have been able to produce simple structures from a single particle type in the past, the researchers claim that this project represents the first time that complex structures have been assembled in solutions from different types of particles. To achieve self-assembly of both magnetic and nonmagnetic particles, the teams employed a ferrofluid solution, which becomes highly magnetized when exposed to external magnetic fields. By modifying the levels of magnetization of the solution, the scientists can control how the particles are attracted or repelled by each other. Manipulated by the magnetization levels of the fluid, the particles are then attracted to each other and begin to form shapes. Using this approach, the team was able to replicate nanostructures that resembled a flower and the planet Saturn. "The key to the assembly of these nanostructures is to fine-tune the interactions between positively and negatively magnetized particles," explains Randall Erb, a four-year graduate at Duke involved in the experiment. "This is achieved through varying the concentration of ferrofluid particles in the solution. The Saturn and flower shapes are just the first published examples of a range of potential structures that can be formed using this technique." Furthermore, the researchers were able to permanently connect the particles to maintain the complex nanostructures using chemical glues and simple heating techniques. This development proved to be essential to the success of the research because the particles disperse when the external field is turned off. Easily repeatable, the self-assembly process could serve as building blocks for future applications that include advanced optics, cloaking devices, and bioengineering.

Record Numbers Attend MD&M West

Webinar Combats Kids' Lack of Interest in Engineering

The American Society for Quality (ASQ; Milwaukee) has made a Webinar titled "Real World of Engineering" available for free on its Web site. Celebrating National Engineers Week, the organization is presenting the Webinar out of concern for ensuring a future work force of highly educated and skilled engineers. The organization's goal in presenting the Webinar is to get more young people interested in the field and to get parents and members of industry to further encourage kids to pursue careers in engineering and science. The National Science Foundation estimates a projected shortage of 70,000 engineers by 2010. Potentially jeopardizing future advances in technology and increasing infrastructure costs, the shortage of aspiring engineers has the organization worried. To try to understand that dark forecast, ASQ employed Harris Interactive (Rochester, NY) to conduct a national survey of kids and young adults about their knowledge of the field of engineering. According to the survey, 85% of kids ages 8–17 said they are not interested in engineering and added that their parents aren't encouraging them to be. This lack of interest is explained in three ways: a lack of knowledge or understanding of the field (44% of respondents from that age group), an assumption that engineering is boring (30%), and a lack of confidence in math and science skills (21%). Further threatening the knowledge transfer from one generation of engineers to the next is the lack of encouragement from parents. Only 20% of the parents of the kids surveyed said they have encouraged or will encourage their children to consider a career in engineering. Moreover, children continue to be negatively affected by the same gender stereotypes that have plagued past generations. Girls who responded to the survey said that their parents are more likely to encourage them to become an actress (21%) than an engineer (10%). Amidst so much talk of tough economic times and renewable or sustainable resources, these statistics can serve as a reminder to industry to continue to invest in its own future by fostering the next generation of engineers. The Webinar will be available on ASQ's Web site for the next 12 months.