Evergreen Medical’s Encompass Lead-Interconnect System is the first pretested integrated lead-interconnect system designed for implantable neurostimulator pulse generator (IPG) devices. The Encompass, enabled by Bal Seal Engineering’s Sygnus contact system and RMS’ premolded 16-channel header technology is intended to save development time and costs for neurostimulation device companies.

“For many years, both startups and established OEMs have been challenged to internally develop their own header and lead components or to outsource the development of each component to different contract manufacturers specializing in either lead components or headers,” says Randall Nelson, founder and president of Evergreen Medical Technologies. “With our Encompass system, neurostimulator device companies no longer have to identify a different source for leads to coordinate with their IPG connectors. The Encompass provides complete functionality in a single system.”

Nelson says that developing a header system in-house or using multiple vendors can lead to significant integration, cost, and quality challenges. Sourcing the components separately, he says, can dramatically prolong device introduction, which commonly increases the overall developmental cost and adds a delay to initial clinical studies.  

Because the Encompass is pretested and already incorporates both the header and the interconnect system, it removes the roadblocks associated with design, development, sourcing, and testing of a final product. In addition, the system reduces the package size needed for different therapy options for IPG developers.

The Encompass has been designed with a port-entry screw-anchor mechanism and can use one of three lead strain relief seal options, varying from a short-transition strain relief seal to a longer strain relief seal for devices requiring a more gradual lead transition from the header port. A slot is molded into the header for the placement of a radiopaque identifier and a suture hole is included. The header has been designed with a set of two anchors to firmly attach the header to the hermetic enclosure.