Assurity™, Endurity™, Allure™ and Ellipse™: New Low Profile Header
Several new features have been made available with the introduction of the Assurity and Endurity pacemakers, Allure CRT-P devices, and Ellipse ICDs, including a new design to the header connector. The new, thinner header design along with the angled top of the pacemakers and ICDs provide two features that not only enhance the overall thinness of the device, but also reduce the acute angle of leads as they exit the connector and are wrapped around the device.
One of the design changes that allows for the thinner header was the removal of the redundant internal sealing rings. Since all IS-1 leads incorporate sealing rings on the connectors, the redundant rings in the header are not needed.
The resulting connector bore dimensions continue to comply with industry standards for IS-1 compatible connectors. The reduction in header thickness and the removal of the sealing rings may change the feel of the lead connector as it is inserted into the header. Insertion of leads with long and flexible connector boots (such as thin LV/CRT leads) may require the implanter to hold the connector boot tighter when inserting leads into the header. If resistance during lead insertion into the header is observed, the implanter may consider applying a small amount of sterile saline, silicone oil or mineral oil to the lead connector to assist in insertion. After the leads are inserted into the device header, the implanter should visually confirm the distal pin has extended beyond the connector block prior to tightening the set screw. Once the set screw has been tightened, pull gently on the lead to confirm a secure connection.
The introduction of the new header provides a smaller overall device profile and remains fully compatible with today’s IS-1 leads. Although most implanters may not notice a difference when inserting a lead, familiarity with the new contoured shaped header is recommended.
If you have any questions about the new header design in the Assurity and Endurity pacemakers, Allure CRT-P family of devices, or Ellipse ICDs, feel free to contact Technical Services at +1-800-722-3774.
Assurity, Endurity, Allue, and Ellipse: New low profile header (157kb)