An extracellular-matrix (ECM) tissue-reconstruction material made mostly of collagen from CorMatrix Cardiovascular has received FDA approval for repair of intracardiac structures. The material has been available for several years for pericardial repair in the United States.
According to the company, the implant indications have been expanded to include suture-line reinforcing, buttressing for soft-tissue reapproximation, and repair of cannulation sites and bleeding sites. It can also be used as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects.
The company also said that the pericardial-repair indication has recently received CE Mark approval in Europe, paving the way for marketing the technology there.
Its proprietary ECM material, the company notes, provides a bioscaffold to which the patient’s own cells migrate. As the patient’s cells populate the matrix, they lay down their own collagen, which matures over time to form a functional tissue repair. The implanted ECM material is gradually replaced and resorbed by the body as the patient’s tissue is remodeled.”
The May issue of MD&DI features an article that reviews human extracellular matrix products on the market and discusses the future of the technology.
May 9th, 2008
Medical News Today reports that Medtronic has recalled several of its heparin-coated devices used in heart-bypass surgery. Devices containing the product Carmeda BioActive will be recalled, including blood oxygenators and tubing packs. The coating compound was found to contain oversulfated chondroitin sulfate.
The company says there have been no reports of patients getting sick, and it is unclear whether exposure at levels from the coating is dangerous. But the goal, it says, is to remove all contaminated products from the market.
Medtronic says it also found tainted heparin in a different coating, Trillium. But the device manufacturer says it won’t recall Trillium products because they contain much less heparin than the other coating. Based on the current data, the benefit of using the affected products outweighs potential risk to patients. Because the maximum possible patient exposure to heparin from Trillium is extremely low, customers can continue to use the affected Trillium products until a replacement is available.
This is a precautionary step by Medtronic, but I wonder if the company is not fueling the panic that patients and caregivers already feel. In a previous blog, I spoke with Joel Gorski of NAMSA, who explained that covalent bonding would likely protect heparin-coated implants from presenting a risk, even if the coatings are tainted. Then again, in most cases, heparin can be easily replaced by other coatings. Perhaps Medtronic is simply trying to mitigate where it can.
Should other manufacturers follow suit?
May 8th, 2008
Medical devices that make use of a tissue-engineered scaffold have been cleared to begin human clinical trials. The devices contain of a nonwoven biomaterial that can be absorbed by the human body called BioFelt (from Concordia). According to the polymer company, preclinical applications include cardiovascular tissue regeneration for arteries and heart valves and orthopedic tissue regeneration of cartilage.
The clinical trials however, are for products in the urological and dental implant markets.
May 2nd, 2008
A novel 3-D screening method for analyzing interactions between cells and new biomaterials could cut initial search times by more than half, researchers from the National Institute of Standards and Technology (NIST) and Rutgers University report in Advanced Materials. The technique enables rapid assessment of the biocompatibility and other properties of materials designed for repairing–or even rebuilding–damaged tissues and organs.
The team demonstrated how to screen cell-material interactions in a biologically representative, but systematically altered, 3-D environment. A key step in the experiment was the researchers’ creating libraries of miniature porous scaffolds that are bone-like in structure but vary incrementally in chemical composition. By understanding the affect of changes in scaffold ingredients to cell responses, researchers can develop biomaterials optimized for particular therapies and treatments.
More on this test system is available from Science Daily.
May 2nd, 2008
Using silver-coated catheters for patients significantly reduced the most common hospital-acquired infection, according to a study published in the April issue of Urologic Nursing, the Journal of the Society of Urological Nurses and Associates.
Two nurses from a 42-bed rehabilitation hospital in Arkansas compared numbers and rates of catheter-associated urinary tract infections (CAUTI) from data they gathered during two periods. The first was a 4-month period in 2006 using a standard latex catheter. The second was a 6-month period using a silver-coated catheter.
Authors Jackie Kassler, RN and Josh Barnett, RN, CRRN of St. Vincent’s Rehabilitation Hospital in Sherwood, AR. discovered 10 nosocomial CAUTIs during the four-month period using the standard latex catheters. During the six-months of silver-coated catheter use, the hospital found no nosocomial CAUTIs.
Kassler and Barnett theorized that silver played a key role in reducing infections. The authors said that although silver has been used in catheters for a decade, products with silver have not yet become standard in most healthcare settings.
St. Vincent’s embarked upon the study in an effort to reduce CAUTI, the most prevalent hospital-acquired infection in the United States (according to the CDC). Most of St. Vincent’s patients are transferred from acute care settings after neurological or orthopedic surgery or for short-term rehabilitation. Average length of stay is approximately 13 days and 85 percent of patients are discharged back to community settings.
According to the release, Medicare’s shift to pay for performance later this fall played a role in the analysis. Medicare has stated that it will not reimburse hospitals for additional care delivered due to catheter-associated urinary tract infections.
April 24th, 2008
MD&DI’s latest Web event, “Building Biomaterials” is now available for download. This event features recognized experts in the world of biomaterials, Len Czuba, Robert Ward, and Gail Naughton. These experts discuss state-of-the-art technologies, such as self-assembing polymers and tissue engineered materials. They also present a view of the current thinking and regulatory structure of the industry.
April 17th, 2008
The North American market for biocompatible materials is the largest worldwide. It is estimated at $13.7 billion for 2008 as stated by Global Industry Analysts Inc in this new report.
Europe represents the second largest market. The three regions collectively account for nearly 80% of the global biocompatible materials market. Polymeric biocompatible materials market in Europe is estimated at $7.6 billion for 2008. Market for metallic biocompatible materials in North America is projected to record a CAGR of 5.4% over the period 2000-2010. Natural biocompatible materials market in Japan is expected to reach $500 million by 2012.
The report says that the global marketplace is relatively concentrated and characterized by several well-established players. Market participants include Angiotech Pharmaceuticals, Artimplant, AP Pharma, AST Products, Biocoat, Biosyntech, Dentsply International, Invibio, Integra LifeSciences, Orthovita, SaluMedica, SurModics, Synthes and United States Surgical.
April 15th, 2008
Fighting bacteria could be as simple as digging in the dirt, reports WebMD Medical News. The news report highlighted a study from Arizona State University that has found three minerals in certain types of clay that target methicillin-resistant Staphylococcus aureus (MRSA), antibiotic-resistant E. coli, and other bacteria.
The scientists studied more than 20 different types of clay to learn about antibacterial minerals in those clays. The researchers hope to harness the minerals to block or treat skin infections. The findings were presented in New Orleans at the American Chemical Society’s national meeting.
April 7th, 2008
Using nature to inspire biomaterials. Its hardly a new concept, but I just read a great National Geographic article on how complicated such a process is. The article explains that only a handful of biomimetic products have successfully come to market because of the enormous complexity of natural structures.
However, such daunting statistics shouldn’t (and hasn’t) discourage researchers from examining the natural world. For example, the journal Science (via the March 28 edition of the San Francisco Chronicle) reported on using the progressive density of a squid beak as inspiration for an orthopedic implant. What is significant about the structure is that at its tip, the squid beak (made of chitin) is hard enough to chew food, but is gradually softer around the base where the structure attaches to muscle. The hard material does come into contact directly with the soft tissue.
The researchers envision prosthetics that are designed in a similar way so that a device would have the elasticity of cartilage near the area of attachment. The other side would be stiff and abrasion resistant.
April 7th, 2008
The World Biomaterials Congress is coming soon. You may want to make your travel plans now *if you haven’t already. Sponsored by the European Society for Biomaterials, the Netherlands Society for Biomaterials and Tissue Engineering and International Conference Services BV, the 8th annual conference will be held May 28 through June 1 at the RAI International Convention Centre in Amsterdam, The Netherlands. Arrange travel, book your hotel, and download conference session at www.wbc2008.com.
March 31st, 2008
Previous Posts
