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Articles from 2010 In May


Polymers Coated with Human Extracellular Matrix Improve Device Biocompatibility

While biomechanically suitable for cardiovascular, urological, and hernia repair applications, many polymers fail because of the body's inflammatory and thrombogenic response. But now, Histogen Inc. (San Diego), a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, has demonstrated that polymers coated with bioengineered human extracellular matrix (hECM) show a statistically significant reduction in immune-cell infiltration, foreign-body giant-cell formation, and fibrous capsule formation. In addition, the coating improves cell binding and proliferation, indicating that hECM could enhance the biocompatibility of various medical devices. Preclinical research on the insoluble, embryonic-like hECM has shown that the coating can reduce negative body responses and improve the performance of medical implantable devices. 

"Device implants represent an important and expanding multibillion dollar market and have had a major impact on patient care," remarks Gail Naughton, CEO and chairman of the board of Histogen. "Problems such as fibrous capsule formation, poor tissue ingrowth, and neointimal hyperplasia resulting from suboptimal biocompatibility must be addressed to offer improved patient benefits. We are encouraged by the results with our embryonic-like matrix, which demonstrate its potential for reducing the foreign-body reaction, as well as improving and prolonging the life and function of implantable devices."

Testing, which was performed as part of a partnership with the National Research Council's Advanced Materials Division, involved coating hECM on several commonly used device materials, including nylon, polypropylene, and polyethylene terephthalate nonwoven scaffolds. Several common coating methods were employed. The hECM-coated and uncoated scaffolds were then surgically implanted in the subcutaneous space of SCID mice, after which histological samples of excised implants were assessed for inflammatory response, cellular infiltration, foreign-body giant cells, and capsule formation.

"Coating polymers with a naturally produced, all-human ECM masks the foreign device material and offers a physiological surface which supports healthy tissue infiltration and interaction," comments Michael Zimber, director of applied research at Histogen. "The hECM-coated polymers promoted a two-fold increase in normal cell proliferation as compared to uncoated polymers, as well as causing a significant reduction in the host inflammatory and fibrotic response to surgically implanted polymers."

Polymers Coated with Human Extracellular Matrix Improve Device Biocompatibility

While biomechanically suitable for cardiovascular, urological, and hernia repair applications, many polymers fail because of the body's inflammatory and thrombogenic response. But now, HIstogen Inc. (San Diego), a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, has demonstrated that polymers coated with bioengineered human extracellular matrix (hECM) show a statistically significant reduction in immune cell infiltration, foreign body giant cell formation, and fibrous capsule formation. In addition, the coating improves cell binding and proliferation, indicating that hECM could enhance the biocompatibility of various medical devices. Preclinical research on the insoluble, embryonic-like hECM has shown that the can reduce negative body responses and improve the performance of medical implantable devices. 

"Device implants represent an important and expanding multibillion dollar market and have had a major impact on patient care," remarks Gail Naughton, CEO and chairman of the board of Histogen. "Problems such as fibrous capsule formation, poor tissue ingrowth, and neointimal hyperplasia resulting from suboptimal biocompatibility must be addressed to offer improved patient benefits. We are encouraged by the results with our embryonic-like matrix, which demonstrate its potential for reducing the foreign body reaction, as well as improving and prolonging the life and function of implantable devices."

Testing, which was performed as part of a partnership with the National Research Council's Advanced Materials Division, involved coating of several commonly utilized device materials, including nylon, polypropylene (PPE), and polyethylene terephthalate (PET) nonwoven scaffolds with hECM using several common coating methods. The hECM-coated and uncoated scaffolds were then surgically implanted in the subcutaneous space of SCID mice and histological samples of excised implants were assessed for inflammatory response, cellular infiltration, foreign body giant cells and capsule formation.

"Coating polymers with a naturally-produced, all-human ECM masks the foreign device material and offers a physiological surface which supports healthy tissue infiltration and interaction," said Dr. Michael Zimber, Director of Applied Research at Histogen. "The hECM-coated polymers promoted a two-fold increase in normal cell proliferation as compared to uncoated polymers, as well as causing a significant reduction in the host inflammatory and fibrotic response to surgically implanted polymers."

Polymers Coated with Human Extracellular Matrix Improve Device Biocompatibility

While biomechanically suitable for cardiovascular, urological, and hernia repair applications, many polymers fail because of the body's inflammatory and thrombogenic response. But now HIstogen Inc. (San Diego) Pre-clinical research on the insoluble, embryonic-like hECM produced through Histogen's unique manufacturing process has shown the capability of the material to significantly reduce these negative responses, and improve the performance of medical devices.Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, will present findings today at the American Society for Artificial Internal Organs (ASAIO) Annual Conference. Assessment of bioengineered, human extracellular matrix (hECM)-coated polymers showed a statistically significant reduction in immune cell infiltration, foreign body giant cell formation (p<0.05) and fibrous capsule formation (p<0.001), in addition to improved cell binding and proliferation, representing the potential for this hECM to significantly enhance the biocompatibility of various medical devices.

"Device implants represent an important and expanding multi-billion dollar market and have had a major impact on patient care," said Dr. Gail Naughton, CEO and Chairman of the Board at Histogen. "Problems such as fibrous capsule formation, poor tissue ingrowth, and neointimal hyperplasia resulting from suboptimal biocompatibility must be addressed to offer improved patient benefits. We are encouraged by the results with our embryonic-like matrix, which demonstrate its potential for reducing the foreign body reaction, as well as improving and prolonging the life and function of implantable devices."

Testing, which was performed as part of a partnership with the National Research Council's Advanced Materials Division, involved coating of several commonly utilized device materials, including nylon, polypropylene (PPE), and polyethylene terephthalate (PET) nonwoven scaffolds with hECM using several common coating methods. The hECM-coated and uncoated scaffolds were then surgically implanted in the subcutaneous space of SCID mice and histological samples of excised implants were assessed for inflammatory response, cellular infiltration, foreign body giant cells and capsule formation.

"Coating polymers with a naturally-produced, all-human ECM masks the foreign device material and offers a physiological surface which supports healthy tissue infiltration and interaction," said Dr. Michael Zimber, Director of Applied Research at Histogen. "The hECM-coated polymers promoted a two-fold increase in normal cell proliferation as compared to uncoated polymers, as well as causing a significant reduction in the host inflammatory and fibrotic response to surgically implanted polymers."

Listen Up: 3-D Scanning Technology Could Improve Hearing Aids

A 3-D imaging technology developed by MIT researchers results in a stretchy, balloon-like membrane that is inserted into the ear canal and inflated to take the shape of the canal.

A 3-D imaging technology developed by MIT (Cambridge, MA) researchers could enable hearing-aid manufacturers to provide better-fitting devices. Achieving a tight fit between the hearing aid and ear canal optimizes sound amplification and ensures minimal feedback between the microphone and receiver, which ultimately leads to a more-effective device for patients with hearing loss.

Conventional manufacturing of a hearing aid requires an audiologist to fill a patient's ear canal with a silicone gel that hardens to form a plaster mold. The mold is then sent to the manufacturer where it is scanned. Using a 3-D printer, the manufacturer produces a custom-fit hearing aid for the patient based on the mold. However, obtaining the initial mold is messy and imprecise, according to the MIT researchers. And, as a consequence, a hearing aid may not be as tightly fitted as desired.

The MIT 3-D scanning technology does not require the use of gooey gel and provides increased accuracy, thereby eliminating the potential need for multiple impressions. "With the new MIT system, a very stretchy, balloon-like membrane is inserted into the ear canal and inflated to take the shape of the canal," according to the MIT News Office. "The membrane is filled with a fluorescent dye that can be imaged with a tiny fiber-optic camera inside the balloon. Scanning the canal takes only a few seconds, and the entire fitting process takes only a minute or two."

Additional benefits of the technology include the ability to determine physical properties of the ear canal as well as how the ear canal reacts to various situations. The latter capability could allow manufacturers to design products that take these findings into account and create a tighter seal as a result.

Although the researchers have a proof-of-concept prototype scanner, they are attempting to create a handheld unit. Manufacturers equipped to receive digital scans could potentially integrate the technology into their existing processes with relative ease.

MDMA Calls on Government to Support Innovation

We will continue to work with Congressional and agency leaders to ensure that patients have timely access to safe and effective products and that innovation continues to flourish.”

Chairman of MDMA, Eamonn Hobbs, also highlighted the importance of government policies. "It is essential that government officials support policies that promote innovation and entrepreneurship so that we may continue to develop the next generation of technologies and therapies that will allow patients to live longer, more productive lives," he said.

High ranking FDA officials were present at the event. FDA principal deputy commissioner Joshua Sharfstein delivered a keynote address and Jeffrey Shuren, CDRH director, participated in a question and answer session.

Software Platform May Enable MRI Design Breakthroughs

The National Research Council Canada's Institute for Biodiagnostics (NRC-IBD; Ottawa, ON, Canada) has teamed up with Schmid & Partner Engineering AG (SPEAG; Zurich, Switzerland) to offer a new software platform for MRI scanner design. Integrating new tools for radio-frequency (RF) array design and postprocessing, the platform is the first software of its kind to combine all the tools needed to design RF-phased arrays into a single user-friendly program, according to the partners.

With the widespread adoption of multichannel MRI systems using parallel imaging, the design and optimization of receive coil arrays has become imperative and more complex. Coil optimization techniques and performance verification are essential steps for designing coil arrays. The combined NRC-SPEAG software platform provides coil designers with the advanced tools needed to analyze, predict, and simulate array elements.

NRC-IBD and SPEAG have each developed tools for designing coils. NRC-IBD's Musaik RF array designer software analyzes and displays multichannel MRI data using various signal reconstruction techniques with either simulated or experimental input data, while SPEAG's SEMCAD X provides customers with magnetic field design tools for the design of MRI systems.

Musaik and SEMCAD X complement each other, since the output of SEMCAD X software forms the input to NRC's Musaik analysis software. NRC's software can also accept experimental data as input or both simulated and experimental data, allowing for extra functionality.

Musaik enables users to evaluate simulated array coil designs and assess their parallel imaging capabilities. Equivalent analysis is available for experimentally obtained raw data, allowing accurate design verification for a range of different design processes or for evaluating simulation model fidelity. It also provides many different view options for simulated data. Musaik can compute 2-D g-factor maps using any integer reduction mathematically allowed with either simulated or experimental data.

Full, complex noise-covariance matrices are computed within Musaik, minimizing users' technical knowledge requirements. This data can be easily used to assess coil isolation during construction troubleshooting. Many different experimental raw-data formats are supported.

SEMCAD X is the latest generation of 3-D finite difference time-domain and finite integration technique full-wave simulation software. Its application range has been extended by effective genetic algorithms, optimization of structures derived from parameterized computer-aided design, and greater speed. Enhancements to the graphics user interface, including the ACIS CAD modeler and the OpenGL renderer, allow the analysis and design of real-world configurations.

SEMCAD X supports MRI applications such as coil optimization and medical implant evaluations. Its thermal solver supports tensorial blood flow models, discrete blood-vessel trees, and temperature-dependent tissue parameters to determine temperature changes and tissue damage. In addition, it provides a large library of high-resolution 3-D CAD-based anatomical human and animal phantoms.

Electrospinning Alternative Offers Controlled Fabrication of Nanofibers

Dissatisfied with the high-voltage electrical fields and low production rate associated with electrospinning processes, researchers at Harvard University (Cambridge, MA) have developed a low-voltage rotary jet-spinning technology that allows for the high-output fabrication of tiny, aligned, 3-D nanofibers. Using only a drum and a nozzle, the technique enables the production of biocompatible nanotextiles for a variety of applications, including tissue scaffolds and artificial organs.

Describing their process as a "cross between a high-speed centrifuge and a cotton candy machine," the researchers employ high-speed, rotating polymer-solution jets to extrude the nanofibers. The desired synthetic or natural material is fed into the machine and then stretched out into long fibers as a result of the high-speed spinning motion. Then, the fibers are extruded through the nozzle by hydrostatic and centrifugal pressures. Polymer-based threads that are 100 nm in diameter can be produced.

The process offers more control than electrospinning, according to the scientists. "Fiber morphology, diameter, and web porosity can be controlled by varying nozzle geometry, rotation speed, and polymer solution properties," the researchers state in an abstract for the journal Nano Letters.

Furthermore, fibers can be fabricated in an array of shapes and textures, and provide flexibility for 3-D structures. The scientists speculate that their equipment could enable the eventual production of miniature scaffolds in vivo. 

Orthopedics Industry Needs a Revolution

Innovation in the estimated $32 billion orthopedics industry has largely been evolutionary, not revolutionary, according to medical device analyst Raj Denhoy of Jefferies & Company Inc. (New York City). Medical intervention hasn’t dramatically changed in the orthopedics sector, and as a result, analysts expect to see about 6% growth during the next five years. Current clinical outcomes for existing implants are already good, so recent and future product introductions are only incrementally better. However, this isn’t bad news. There is still a great clinical need for orthopedic devices, and they’re the most successful medical interventions from a surgical standpoint, said Denhoy, who spoke at the OrthoTec conference in May.
 

Underlying demographics, including an aging population, rising obesity rates, and increased fitness, are driving growth in this industry. This year, more than 40 million people will be over the age of 65. By 2030, this number will increase to more than 71 million, and by 2050, it will hit more than 87 million, said Denhoy. On the obesity front, more than half of the U.S. adult population is overweight and more than one-third are considered obese. And even those people who regularly engage in a high level of physical activity (about 20% of Americans) might require orthopedic devices to stay active. All of these factors contribute to the demand for orthopedic devices.
 

However, pricing pressures remain a concern as more power is slowly shifting from surgeons to hospitals, and this is only expected to get worse. This means surgeons will have less power over which devices they can use on patients. In addition, implants have become commodities, and there isn’t a lot of truly new technology coming down the pipeline. As Denhoy put it, the industry is “running to stand still.”
 

Even the once-hot spine market has cooled down. During last year’s fourth quarter, Medtronic and Zimmer Holdings reported negative growth (–1% and –15%, respectively) in their spine deivision. Synthes, Stryker, and Biomet all saw modest 6% growth, and Johnson & Johnson reported just 3% growth. However, NuVasive broke this mold with 43% growth. Despite the slower growth in spinal devices, this segment, along with extremities, has seen more innovation than others in orthopedics.
 

The final piece of the puzzle is healthcare reform, the effect of which remains to be seen. However, hospitals will be placed under increasing pressure, and manufacturers will face pricing issues. The outlook for this industry remains challenging, said Denhoy.
 

Lawmakers Ponder Transparency for Tax Credits

(Traditional tax credits reduce a company's state income tax, while refundable tax credits can be sold or traded back to the state for cash.) The film industry is the biggest recipient of this tax incentive, although device companies will obviously be affected. MassMEDIC raised no objections to the measure, which is likely to become law with the Senate's approval (the House approved a similar bill last month).

“It seems to me that information should be made available to the public,’’ said MassMEDIC president Thomas Sommer.

Is Penang the Next Device Paradise?

One report says that contract manufacturer Accellent is looking to invest about $82 million in a manufacturing facility at the Bukit Minyak Science Park. The company, which provides precision manufacturing and engineering services for devices used in drug delivery, neurology, endoscopy, orthopedics, and cardiology, plans to offer these services to customers in the region. One of its customers, St. Jude Medical, is slated to start its own operations in the region next year.