Greatbatch Medical's OptiSeal Valved PTFE Peelable Introducer receives 510(k) clearance

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