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Nanomagnetic Coating Improves Implant Visibility during Imaging

NANOTECHNOLOGY

Nanomagnetic Coating Improves Implant Visibility during Imaging

Shana Leonard

While many companies are discussing how they will use nanotechnology to change the medical device industry, one firm is actually doing it. Biophan Technologies Inc. (West Henrietta, NY; www.biophan.com) has created a thin-film nanomagnetic coating that reduces image artifacts and enhances the visibility of implantable devices during MRI.

MRI is emerging as the preferred testing method for soft tissues and certain medical anomalies that may indicate such serious problems as heart attack or stroke. Though MRI has gained trust in the medical field, a catch-22 exists. Patients who have implantable devices are often those with histories of problems best detected by MRI. These are the people who would most benefit from an MRI, yet patients who have certain implantable devices are unable to undergo the process because of some implants’ incompatibility with the imaging technology.

In an effort to overcome this obstacle, Biophan developed a nanomagnetic coating that can be applied to implantable devices without negatively altering their properties.

“We discovered in the course of this work that there was also a problem with the visibility of implants during MRI; some devices created artifacts and others were invisible,” says Mike Weiner, CEO of Biophan. As a result, the company focused its energy on tailoring the coating to resolve the limited visibility problem that was plaguing MRI procedures.

The coating can be applied to virtually any implantable device and has a number of MRI-related uses, according to the company. Among the most common applications are guidewires, catheters, and stents. When applied to stents, the coating enables the doctor to check for restenosis, or renarrowing of the implant, via MRI, according to Weiner. Many metallic stents do not currently allow imaging of the stent interior and often create misleading imaging artifacts.

“Now, you have to do an invasive procedure called an angiogram to detect if a stent’s closed up or slightly closed up,” he says. “With our coating on a stent in the future, you’ll be able to just do an MRI and actually see inside the stent to see if it’s clogged and exactly how much. It’s a major breakthrough.” The same principle can also be applied to vena cava filters.

Another prospective benefit for implantable devices is the coating’s illumination of a catheter and its tip at any time under MRI. This capability may enable the guidance of a procedure while a patient is undergoing an MRI, according to Weiner. Furthermore, the company claims that the application of the coating to a range of implantables eliminates image artifact problems. In turn, healthcare professionals can view how well a device is situated in the surrounding tissue, an important detail doctors could not address with MRI in the past.

Biophan hopes that the integration of the coating on implantable devices, with its additional solutions for MRI safety, will open the door to expanded MRI use for procedures formerly deemed unsafe or ineffective when using MRI. “The nanomagnetic coating will allow better use of MRI diagnostics for the patients who have implantable devices, as well as allow procedures to be done under MRI that today can only be done under x-ray,” says Weiner.

Copyright ©2006 Medical Product Manufacturing News

Permanent FDA Commissioner Imminent?

For Nanotech, It's Safety First

The nanotechnology revolution is underway, but expect it to proceed slowly. This morning's Washington Post reports on a survey of nanotech usages. Of more interest, though, is the second half of the article, which discusses safety issues. Specifically, too little is known about them, and some companies have been reluctant to let the government do testing and evaluation. That's not an option with medical device applications, of course. FDA will have a say on safety and effectiveness before any device-related application hits the market. But until more is known about safety issues, don't expect a speedy review process. The only way to speed it up is to help FDA and other agencies however you can in research they are conducting and sponsoring.

Shaping the World on a Grand Scale

NANOTECHNOLOGY

Shaping the World on a Grand Scale
Shana Leonard
Imagine an era in which cancer is easily detected and treated. Imagine a time in which injecting thousands of tiny computerized devices into the human body as a form of medical treatment is commonplace. Imagine this reality within your lifetime.

The possibility of these scenarios may be fast approaching with the aid of nanotechnology. Generally defined as working with parts smaller than 100 nm, nanotechnology is expected to spawn a revolution that will affect many industries, including medicine. But despite the hype, multimillion-dollar R&D, and rampant flow of ideas, few concepts are tangible—yet.

Many of the theories and research made possible by nanotechnology may not come to fruition for anywhere from 5 to 20 years from now, if at all. However, the mere prospect of these ideas has prompted the establishment and heavy funding of R&D organizations. Even the U.S. government has invested millions of dollars in advancing nanotechnology through its National Nanotechnology Initiative.

Researchers are focusing much of their attention on cancer detection, prevention, and treatment. Because of its ardent belief in nanotech solutions for cancer, the National Cancer Institute (NCI) has established the NCI Alliance in Nanotechnology for Cancer. The group is “engaged in efforts to harness the power of nanotechnology to radically change the way we diagnose, treat, and prevent cancer,” according to its mission statement. The alliance will fund $144.3 million in R&D over the next five years.

Much of this sum will go toward the development of nanodevices, viewed as instrumental in the battle against cancer. Nanodevices operate on the molecular level and are often small enough to enter cells without disrupting the body’s natural state. The hope is that these devices will enable doctors to detect cancer and effectively treat the disease in its earliest stages. With objectives ranging from DNA mapping to tumor destruction, these devices could prevent or relieve human suffering.

Among the most talked about nanodevices is the nanotube. This carbon-based rod is predicted to have a number of capabilities, including marking and mapping mutations in DNA for predicting cancer, says the NCI.

Additionally, nanotubes are being championed as useful tools for everything from drug delivery to electronics. Physicists at the University of Pennsylvania used nanotubes to develop an electronic circuit, which they predict will be integral in making chemical sensors and high-speed microprocessors. Nanotubes are also undergoing tests as drug-delivery vehicles; a French and Italian research team successfully made nanotubes transport antifungal agents. And a report in the June 14, 2005, issue of the American Chemical Society’s journal, Chemistry of Materials, posited that an injected solution of nanotubes could alter the way in which broken bones are treated.

Similar to nanotubes, nanorobots are machines comprised of nanoscale parts, according to Robert Freitas, author of Nanomedicine. Theoretically, nanorobots would serve as internal soldiers of sorts. Many of them could be injected into the body at one time with an assigned task. The robots would then perform the task and leave the body.

Freitas’s example of a possible nanorobot is the “respirocyte.” In his model, the bot would act as an artificial mechanical red cell, releasing oxygen or carbon dioxide into the body in a controlled manner. To stabilize the body, the balance of gases would be measured by onboard sensors and released accordingly. Every action would be controlled by a built-in computer.

Some nanorobots may attack tumors. Other types could provide drug delivery to targeted areas. Despite their differences, all devices must have the ability to let doctors disable them if necessary. None should be able to self-replicate inside the body, according to Freitas and many other advocates of nanotechnology.

But to build these molecular-sized devices, precise equipment is imperative. Thus, nanotechnology will also be used to manufacture the nanodevices.

“Molecular manufacturing systems can be envisioned as factories operating at the nanometer level, including nanoscale conveyor belts and robotic arms bringing molecular parts together precisely, bonding them to form products with every atom in a precise, designed location,” explained Christine Peterson, president of the Foresight Institute, in a 2003 hearing of the United States House of Representatives Committee on Science.

Many experts in the nanotech field visualize these manufacturing systems as simpler systems than their full-sized counterparts, but equipped with the same capabilities in a smaller package. If realized, such systems would increase rapid prototyping capabilities while decreasing costs. Molecular manufacturing would result in microscopic computers, motors, and nanosensors—not to mention the planned lab-on-a-chip possibilities that could result from successful nanomanufacturing.

With all of its potential, nanotechnology seems to have infinite boundaries and positive applications. The drawback? An ongoing ethical debate.

Though nanotechnology could vastly improve global health, some critics remain leery of potential social implications. Whereas the impact of nanotechnology could be the eradication or control of common terminal diseases, its results also could be devastating. The Center for Responsible Nanotechnology, a nonprofit organization, emphasizes responsible use and the importance of keeping the public informed. The group cautions that a lack of proper education and collaboration during the advancement of nanotechnology could prompt the development of horrifying weapons of mass destruction. Or it could even enable a government to trace its population every movement, conversation, and thought. The result? A terrifying Big Brother–type regime.

A slew of other skeptics doubt the safety of nanoparticles in the human body. Since devices are still in the development stage, end results remain uncertain. There exists the possibility that nanorobots may be dangerous. In fact, Project Censored, a research group from Sonoma State University (Rohnert Park, CA; www.projectcensored.org) identified the relatively unchallenged positive slant on nanotechnology as a newsworthy issue in its yearbook, Censored: The News That Didn’t Make the News. Hailing from an article written for The Chronicle of Higher Education, the topic was named one of 25 news stories of social significance that were overlooked, underreported, or self-censored by the national media.

In addition to physical threats, nanotechnology poses an ethical threat as well. Even prior to the actualization of these concepts, people are questioning them. Moral debates thrive. For instance, is life extension moral and will it lead to overpopulation? Will people use this technology to “play God”? And is it ethical to manipulate genes and alter the species? These are points of contention that will most likely become hot-button issues over time, if the current presence of these debates is any indication.

Though these concerns are legitimate, they come with uncharted territory. As with every new technology, there are risks. However, do the benefits outweigh the risks? If nanotechnology is used responsibly, as most nanotech agencies promote, the answer may be yes. The notion that we may be able to nip cancer in the bud, grow new organs, and reduce suffering is appealing to most people. In the case of nanotechnology, only time will tell how big an impact the very small will have.

Copyright ©2006 Medical Product Manufacturing News

Guidant's Ethics in Question Again

The comments were unveiled during the course of a product liability lawsuit in Texas. The question of what to reveal and when is a tricky one. Disclosing too much information too soon can lead to unwarranted hysteria. But it appears Guidant went too far in the other direction, and is paying the price now.

What's in a Name?

The public will be less likely to associate the new company's products with Guidant's mishaps. And the change underscores the new entity's desire to make a fresh start. Still, Guidant did a lot of good for healthcare over the course of its existence, and it is unfortunate to see its name relegated to the history books -- and back issues of MD&DI, of course.

Manufacturer Adds Dimensions to Web Site

E-NEWS

Manufacturer Adds Dimensions to Web Site
Shana Leonard
www.royalpins.com
Royal Diversified Products Inc. (Warren, RI) has unveiled a Web site that may facilitate simple integration of its components into a user’s existing product. Equipped with 3D PartStream.net, the site allows registered visitors to select and customize ejectors, punches, and core pins. Users can then view 3-D models and 2-D drawings of the parts, download them, and apply them directly to their CAD system. More than 20,000 standard components and 3-D drawings are available, along with prices. Registered users can also browse an online catalog and request a quote; unregistered users have access to product details and updates.
Copyright ©2006 Medical Product Manufacturing News

New Program Publicizes Ethics

Most of the elements specify programs and processes that must be followed. Making such compliance visible could increase a firm's credibility with caregivers and patients. And we are in an era where industry needs that more than ever.

Cable Company Assembles New Material for Site

E-NEWS

Cable Company Assembles New Material for Site
Shana Leonard
www.cmcorporation.com
The modified Web site for a manufacturer of cable, cable assemblies, and coil cords allows users to navigate easily through a vast amount of information. Designed to include such standard features as product specifications and an outline of services offered, the C&M Corp. (Wauregan, CT) site also showcases a range of resources. A cable design guide serves as a valuable tool for engineers, while the Ask C&M section aims to help users with development challenges. Links to PDF brochures and a library of cable-related literature are also presented on the site.
Copyright ©2006 Medical Product Manufacturing News

Postmarket Issues Still Top Schultz' Agenda

Among CDRH's priorities for FY 2006, he said, are to "increase our ability to identify, analyze, and act on postmarket information" and to "increase communication of risk/benefit issues to all of our stakeholders." Specific tasks, he said, include strengthening Condition-of-Approval studies, improving the MedSun program, boosting the center's automated information systems, and focusing on risk-based inspections. Then there is the Medical Device Postmarket Transformation Initiative, which takes a more macro perspective, looking at how CDRH can change its culture and systems to better manage postmarket information. These are extremely tough challenges, but Schultz isn't the type to shy away from them. Neither should you.