When SynCardia needed to ensure a totally reliable signal in a portable artificial heart, it turned to Smiths Connectors.
A recognized leader in the mechanical circulatory support industry, SynCardia Systems of Tucson, Ariz., manufactures the SynCardia temporary Total Artificial Heart as a bridge to transplant for patients who are dying from end-stage biventricular failure and are on waiting lists for heart transplants. SynCardia’s Total Artificial Heart is the only FDA-, Health Canada- and CE-approved Total Artificial Heart in the world.
For patients being kept alive by the Total Artificial Heart, their wait for a donor heart has typically been one of forced hospital confinement, tethered to a large console that powers and monitors the Total Artificial Heart. SynCardia’s Big Blue Driver is the only FDA-approved driver for powering the Total Artificial Heart in the United States, but it is a 418-pound device. SynCardia began to develop a suitable portable substitute for Big Blue that would provide patients stability and the opportunity to be discharged from the hospital to live in the comfort and familiarity of their own homes while waiting for donors.
SynCardia’s research and development produced the Freedom portable pneumatic driver as an alternative power source to its hospital-based Big Blue driver. The Freedom driver weighs in at 13.5 pounds and can be placed in a backpack or in a shoulder bag, providing patients hands-free operation. The Freedom driver is currently an FDA-approved Investigational Device Exemption (IDE) clinical study in the US.
An issue of paramount concern to SynCardia during the development of the Freedom driver was to make certain that total signal reliability was maintained. This challenge included a critical need for reliable and dependable interconnect systems within the product. SynCardia turned to Smiths Connectors, a proven connector vendor with a track record of success in the medical device industry. Smiths’ specialized design and development of interconnect systems met SynCardia’s vital requirements with color coding, sealing, keying, and simple mating action.
Smiths’ design engineers worked closely with the SynCardia team to create an interconnect system of cable assemblies and connectors for the Freedom driver that could confidently deliver complete reliability. The combination of the Smiths HyperGrip and D-Series interconnect solutions within the SynCardia Freedom driver addressed the unique demands and requirements of this life-sustaining application.
SynCardia is currently conducting an FDA-approved clinical study of the portable Freedom driver system. The IDE clinical study is designed to demonstrate the suitability of the Freedom driver as a pneumatic driver for stable Total Artificial Heart patients and can be safely used at home. The Freedom driver has received CE approval for commercial use in Europe.
The interconnect solutions from Smiths within the Freedom portable driver are a key element in ensuring the reliability and dependability of this SynCardia device that can now make a positive difference in the lives of critical cardiac patients around the world.