NavAlign IVC Filter Delivery Device

Delivery and retrieval in one

Pulmonary embolisms (PE) affect thousands of Americans each year, and if left untreated, can kill one out of three individuals. PEs occur when a blood clot becomes dislodged from the vein wall and migrates to the lung, blocking blood flow in the pulmonary artery. To combat this life-threatening condition, surgeons implant IVC filters to trap embolisms before they can cause damage. Cook Medical partnered with Farm to redesign their existing IVC filter delivery system to make it easier to install these life-saving vascular devices.

Farm conducted human factors and usability research, including surgeon interviews and extensive task analysis, to better understand the physical and cognitive steps required to position and deploy a filter. We discovered unnecessary steps in the workflow as well as critical elements of the existing design that contributed to user error and possible misalignment of the filter. The team then created concepts that addressed these issues and tested them with users to compare single or two-handed approaches, as well as to define many ergonomic and cognitive improvements.

Farm's filter delivery system eliminates the effects of pull/push and rotation on the filter, reducing the potential for misalignment. We designed a unique tactile feedback feature into the delivery tool that lets the user feel when the filter is in the correct location. This allows the surgeon to watch the display monitor and eliminates premature deployment. We also reduced the number of steps needed to complete the deployment of the filter, and engineered the product to be more cost-effective to manufacture. The result is a simplified device that features precise control, increased accuracy, and improved device efficacy.

The NavAlign system has exceeded user expectations. It is a totally unique and highly intuitive device that includes features unavailable on any other IVC filter delivery system on the market today.

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