Sterling Medical Devices Creates Controller to Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

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Controller to Power Groundbreaking New Multi-Pump
Mechanical Circulatory Support Device

Medical Device Need

A controller for an implantable heart pump that integrates into an intricate and small device
Added expertise to ensure device in development was safe and reliable

Why They Chose Sterling

The client engaged Sterling Medical early in the process to extend their expertise and create a controller for an implantable heart pump that integrates into their incredibly small device to ensure its reliability, redundancy, and safety.

Project Challenges

Puzzle Medical Devices Inc., a leading medical device company, developed a minimally invasive multi-pump mechanical circulatory support (MCS), the ModulHeart™, to reduce cardiac stress and improve renal perfusion in patients with advanced heart failure (HF). Puzzle Medical’s design included three parallel endovascular pumps to augment patient perfusion at lower pump speeds than traditional MCSs, preserving blood integrity and reducing the risk of thromboembolic events. Adding additional pumps to the system required significantly smaller components and streamlined design.

How Sterling Added Value

Sterling’s team of experts:

Developed a system architecture for a control device that could accommodate the function of all three pumps on the implantable heart simultaneously.
Utilized redundancy to ensure the continued safe functioning of the device if one of the pumps or subsystems encountered an error.
Created a circuit board with a sophisticated power management system reducing the risk of power interruption as an additional safety measure.
Incorporated an independent alarm alerting the patient of any malfunction.
Partnered with the client to integrate data collection capabilities into the device to power critical insights.

Success

In less than 12 months, the device was designed, developed, and placed into pre-clinical trials. The first-of-its-kind device recently completed its first in-human study where all four participants experienced improvements in cardiac and kidney function. Additionally, the device was successfully deployed, activated, and removed, with no procedural or device-related complications. ModulHeart™ offers the potential to safely help millions of patients suffering from heart failure who currently have limited treatment options and was awarded the Breakthrough Device Designation from the FDA.

Resources

July 29, 2022

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