Bayer MaterialScience LLC announces new measurements that illustrate the durability of its Baymedix™ CL 100 lubricious coating technology. Catheters with Baymedix CL 100 coatings, subjected to demanding simulated-use tests, released far fewer wear particles than the levels defined by the United States Pharmacopeia (USP) 788 standard.
Medical devices used inside the body shed wear particles during use – a
phenomenon known as particulation. To reduce risk to patients, manufacturers
seek to minimize the release of these particles. Hydrophilic lubricious
coatings, used on devices like cardiovascular catheters, are particularly susceptible
to particulation: the water they absorb makes them slippery when wet and easier
for physicians to use, but it also makes them weaker. The stress of being
inserted into narrow, tortuous blood vessels can break particles off the
surface of a coated catheter.
The unique technology behind the Baymedix CL 100 lubricious coating product
gives it an advantage in particulation resistance. Because the polymer coating
is grown directly from a material surface, it is extensively bonded to the
substrate through strong, covalent linkages. This bonding, along with the
polymer entanglement that strengthens the coating itself, helps create an
especially durable coating resistant to particle
To quantify particulation, device engineers often use the USP standard 788,
“Particulate Matter in Injections.” The
data is sometimes used to support manufacturers’ applications to the U.S. Food
and Drug Administration (FDA) to market certain medical devices.
In the simulated-use test performed on a Baymedix CL 100-coated catheter, the
coating performance far exceeded the established standards. The number of
generated particles greater than 10 microns in diameter was 59 percent below
the limit defined by USP 788, and the number of particles greater than 25
microns was 78 percent below the limit.
The key to meaningful particulation testing is generating the particles using
an appropriate test. Jeffrey Motley, R&D Manager for the Bayer
MaterialScience Medical Coatings Development Centre in the United Kingdom,
explains, “FDA guidelines state that the generation of particulates should be
performed to as closely as possible resemble the actual use of the
device.” Bayer used a coronary vascular
model relevant to many of its customers’ devices.
Notably, Bayer was able to achieve its results with the demanding method of
repeated insertion and removal of the device through a highly tortuous glass
path. Said Motley, “We believe it represents a worst-case scenario in terms of
Paul Nowatzki, Business Development Manager for Bayer MaterialScience LLC,
offered some perspective. “These results support the conviction we have had for
a long time – that Baymedix CL 100 coatings offer superior durability and
Bayer MaterialScience has a team of professionals exclusively dedicated to the
development and commercialization of its Baymedix portfolio of materials for
medical devices, which includes drug-eluting coatings and materials for wound
For more information about Bayer MaterialScience LLC's coatings, adhesives or specialties, call 412-777-3983, email firstname.lastname@example.org
or visit www.bayermaterialsciencenafta.com.
Lubricious Medical Coatings Resist Particle Shedding During Use
November 1, 2011