Puzzle Medical Devices Inc., is a leading medical device company specializing in the development of a minimally invasive multi-pump mechanical circulatory support (MCS) designed to reduce cardiac afterload and improve renal perfusion in patients with advanced heart failure (HF). They partnered with Sterling Medical Devices to design and create a controller that could be integrated with the intricately small device to ensure its safe, reliable operation.
MCS devices are used to help the heart pump blood in the treatment of both acute and chronic heart failure. While lifesaving in many cases, MCS devices are associated with significant mortality and morbidity. Current percutaneous devices pump blood incredibly fast, increasing the risk of hemolysis, vWF depletion, and platelet activation, which can lead to blood damage, bleeding complications, and high stroke risk. To address this critical issue, Puzzle Medical set out to develop a device that could offer improvements in cardiac and kidney function while preserving blood integrity and reducing the risk of thromboembolic events.
They created ModulHeart™, a minimally invasive heart pump with a modular design that allows for hemodynamic support through three parallel endovascular pumps, which is intended to provide augmented patient perfusion at low pump speeds and with low shear imparted to the blood.
Puzzle Medical’s team of innovators engaged Sterling Medical early on in the process to extend their expertise and create a controller that could be integrated with the incredibly small device to ensure its reliability, redundancy, and safety.
Sterling developed a system architecture for a control device that could accommodate the function of all three pumps simultaneously. Utilizing several blocks of redundancy, the controller was designed to ensure the continued safe functioning of the device in the event that one of the pumps or subsystems were to encounter an error. As an additional safety measure, they created a circuit board with a sophisticated power management system, including multiple levels of redundant power supply, to reduce the risk of power interruption, as well as an independent alarm handling system to alert the patient should a malfunction occur. In addition to creating a stable motor controller that could adequately support the continuous functioning of the device, the Sterling team also partnered with the client to integrate data collection capabilities into the device to power critical insights.
The Sterling team and Puzzle Medical’s team of engineers enjoyed a highly collaborative relationship that fostered innovation and problem-solving to create a controller that could accommodate the exceedingly small pump. As a result, in less than 12 months, the device was designed, developed, and placed into large animal trials.
With a sophisticated controller in place to support the multi-pump design, 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. Awarded the Breakthrough Device Designation from the FDA, ModulHeart™ offers the potential to safely help millions of patients suffering from heart failure who currently have limited treatment options.
September 20, 2021
February 18, 2021