About 3-5 percent of people over age 65 have aortic valve stenosis, a condition that affects one of the four valves that control blood flow in and out of the heart. The condition causes the aortic valve to thicken and stiffen, reducing blood flow. It can be a life-threatening condition — from the onset of symptoms, the average survival rate is 50 percent at two years and 20 percent at five years.
For patients who are not candidates for traditional open heart valve replacement surgery, Boston Scientific’s transcatheter aortic valve replacement (TAVR) is a potentially life-saving option. The procedure involves a device that resembles a stent with a valve sewn into it. The physician inserts the specialized stent through a small incision in the leg and guides it through the femoral artery into the beating heart. Once in position, the physician deploys the new valve, pushing the old leaflets out of the way. No opening of the chest or stopping of the heart required.
Other TAVR technologies don’t provide the degree of precise control, nor do they allow the physician to adjust the position of the valve. This means the physician needed to achieve perfect placement of the valve on their first attempt and would not be able to fully evaluate the performance of the valve until committing to the final placement. The valve can leak if it isn’t placed correctly, which is a proven predictor of mortality. Sadra Medical, a Silicon Valley-based company, envisioned a next-generation system that allowed for physicians to completely deploy the valve in the patient’s heart and then reposition or retrieve the device if they were not satisfied with its performance.
Clinical work with physicians determined that Sadra’s first generation deployment system was too complicated and convoluted for broad adoption. The company asked Design Concepts to create a more user-friendly mechanism so that it could continue to focus on the device’s distal-end technology.
The resulting delivery system is the first to enable precise positioning, repositioning and retrieval of the stent at any time prior to release of the aortic valve implant. The Delve team focused on blending some of the functions to make the handle easier to use with a number of fail-safes to help prevent operator error. We simplified the mechanism, blending the sheathing and locking functions into one continuous motion, and engineered a simplified release sequence. The deployment handle was designed to follow a lock-step process that makes it impossible for the user to do any step out of sequence.
To help train new users and promote the Lotus Valve device, Delve created a prototype simulation device to mimic the feel of using the handle with an interactive application showing the process. The prototype and application were so successful we created an additional 80 simulation devices and enhanced the application to better train proctors and physicians. We also created an iPad app to be used at trade shows and in client meetings to help show how the device works.
Boston Scientific acquired Sadra Medical in 2011 and the Lotus Valve System is currently in use in Europe. The FDA approved the Lotus Edge Valve System for use in the US in 2019.
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