Evergreen Medical Technologies has launched the Encompass Lead-Interconnect System, which, according to a company release, is the first pretested integrated lead-interconnect system designed for implantable neurostimulator pulse generator devices. The Encompass is enabled by Bal Seal Engineering’s SYGNUS implantable contact system and a premolded 16-channel header technology (rms company).
Randall Nelson, founder and president of Evergreen Medical Technologies commented: “With our Encompass system, neurostimulator device companies no longer have to identify a different source for leads to coordinate with their implantable pulse generator connectors. The Encompass provides complete functionality in a single system.”
Nelson said that developing a header system in-house or using multiple vendors can lead to significant integration, cost, and quality challenges. He said that sourcing the components separately can dramatically prolong device introduction, which commonly increases the overall developmental cost and adds a delay to initial clinical studies.
According to the company, the Encompass is pretested and already incorporates both the header and the interconnect system; therefore it removes the roadblocks associated with design, development, sourcing, and testing of a final product.
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, according to the release. 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.
The Encompass is expected to be demonstrated at the International Neuromodulation Society 11th World Congress in Berlin (8–13 June).