Published on March 17, 2010 at 7:37 AM
Greatbatch Medical announced today that it has received regulatory
clearance for its next generation valved peelable introducer used in the
delivery of leads and catheters into the venous system. OptiSeal™ Valved
PTFE Peelable Introducer achieved regulatory clearance on Monday, March
15, 2010, representing the first 510(k) regulatory approval under the
Greatbatch Medical brand. It is also approved in Canada and CE marked
for distribution in Europe.
“This represents a significant milestone in our strategy to supply
complete systems solutions to our OEM customers”
“This represents a significant milestone in our strategy to supply
complete systems solutions to our OEM customers,” said Mauricio
Arellano, senior vice president of cardiac and neurology, Greatbatch
Medical. “This is an excellent example of how Greatbatch Medical is
partnering with its customers to provide niche systems solutions that
are not a core product of our OEM customers, but which fit perfectly
into our expertise and capabilities. Being able to provide value-added
services, such as global regulatory support to our customers, is a
direct result of the significant investments we have made over the last
several years.”
OptiSeal was developed by Greatbatch Medical in collaboration with its
various OEM customers. Once final distribution agreements have been
reached, which is expected in the second half of this year, OptiSeal
will be manufactured by Greatbatch Medical and distributed worldwide by
our OEM customers.
Source Greatbatch Medical