iPerf announced the first-in-human use of its new dual-flow femoral arterial cannula device. Lyon, France-based iPerf designed its device to integrate an additional flow to prevent the risk of limb ischemia in the cannulated leg. This device features an innovative positioning system for percutaneous placement in critical care and cardiac surgery.
iPerf said its device could reduce the severe complications associated with extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass (CPB) cannulas. During surgery or before treatment, ECMO and CPB support devices temporarily take over heart function and blood oxygenation. They aim to maintain organ perfusion.
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During ECMO and CPB, a cannula inserted into the femoral artery directs blood to the upper body, where vital organs reside. But, obstruction of the artery at the point of insertion often causes lower limb ischemia, iPerf says. It designed its device to enable 90% of blood to flow directly to the upper body and vital organs. The remaining 10% goes to the cannulated lower limb. iPerf’s dual-flow device also maintains secondary blood perusion in the leg.
The device could provide use in cardiac failure associated with myocardial infarction, aggravation of a cardiac pathology, major cardiothoracic surgery or even as part of minimally invasive cardiac surgery.
“Our device has great potential and is likely to become the gold standard for extracorporeal circulation. This first clinical study marks a major step for iPerf, after successfully overcoming the riskiest stages of development,” said Maya Bertron, iPerf CEO. “We are working on a Series A funding round and simultaneously looking at establishing industrial partnerships with different key players. We are convinced that the results of this trial will generate strong interest from practitioners, investors and international medical technology companies.”
iPerf recruited its first treated patient as part of a trial conducted at the Jacques Cartier Private Hospital in Massy, France. The patient recieved the device as part of a minimally invasive surgical aortic valve replacement (SAVR) by mini-sternotomy with peripheral CPB.
Now, the company plans to conduct its approved first-in-human trial of 15 patients receiving cardiopulmonary support for less than six hours. It aims to look at the patented device’s safety and the quality of lower limb perfusion.
In 2027, the company plans to conduct a second clinical study aimed specifically at ECMO. It plans to use the device during specific procedures associated with a heightened risk of ischemic complications. The company also intends for the cannula to integrate an innovative anti-thrombogenic function.
“It is important to sustain R&D investment in new surgical devices in France,” said Dr. Fabien Doguet, cardiovascular and thoracic surgeon, principal investigator of the study. “Starting out with an everyday problem and coming up with innovative solutions is the best way to advance our specialist fields. iPerf subscribes to this mindset and we are proud to contribute.”
