iPerf, a French company specializing in the development of innovative medical devices for cardiopulmonary support, has announced the conclusion of its first clinical trial evaluating its dual-lumen femoral arterial cannula for cardiopulmonary support.
Designed to provide arterial flow for cardiopulmonary support while maintaining blood flow to the cannulated limb, the device aims to address limb ischemia, a serious vascular complication associated with femoral arterial cannulation in critical care and cardiac surgery.
The study evaluated the device in 15 patients receiving femoral cardiopulmonary bypass for minimally invasive cardiac surgery. Tissue oxygenation was monitored in the cannulated leg throughout the procedure using near-infrared spectroscopy (NIRS). No device-related serious adverse events were reported during the trial, while NIRS monitoring showed maintained tissue oxygenation in the cannulated limb. The clinical trial was led by Dr Pierre Demondion and Pr Fabien Doguet, cardiovascular and thoracic surgeons at the Institut de Chirurgie Cardiaque, Hôpital Privé Jacques-Cartier, in Massy, France.
The device, developed by the co-founder of iPerf, Pr. Pierre Mordant, thoracic and vascular surgeon at the Hôpital Bichat (AP‑HP, Paris-Cité University), is designed to reduce the severe complications associated with femoral ECMO (ExtraCorporeal Membrane Oxygenation) and CPB (CardioPulmonary Bypass) cannulas. These cannulas are used in cases of cardiac failure associated with myocardial infarction, aggravation of a cardiac pathology, cardiac arrest, or as part of minimally invasive cardiac surgery. The device also features an innovative positioning system for percutaneous placement, making it the first solution of its kind.
Completing this clinical trial marks an important milestone in our efforts to address one of the key challenges associated with femoral arterial cannulation We are grateful to the investigative team for their dedication and commitment to this trial. We look forward to presenting our results at the AATS Mechanical Support and Thoracic Transplantation Summit next month.
Maya Bertron, CEO of iPerf.
“This simple and elegant solution could represent a significant advancement in patient safety, not only in the context of ECMO, but also for cardiopulmonary bypass procedures involving femoral cannulation – by helping to prevent any risk of ischemic complications,” said Dr. Pierre Demondion.
ECMO and CPB procedures are widely used, with more than a million procedures worldwide in 20251. The global market for cardiopulmonary support is expected to reach $2.8 billion in 2032, driven by cases of cardiopulmonary failure, increasing use of ECMO in intensive care, development of its use in off-premises emergencies and the growth of minimally invasive cardiac surgery.
A key objective of the company is to generate robust clinical evidence in the fields of ECMO and CPB, with the aim of enhancing patient safety in both critical care and cardiac surgery. iPerf plans to submit its ECMO-focused clinical study in Q4 2027.
iPerf is a French company specializing in the development of medical devices for cardiopulmonary support. AP-HP filed three patents to protect the company’s technological innovations, granting the start-up an exclusive worldwide license. After producing 1,500 prototypes and validating the preclinical phase, the company launched a clinical trial in 2026, successfully operating on 15 patients.
Professor Pierre Mordant, MD, PhD, thoracic and vascular surgeon at the Hôpital Bichat (AP‑HP), highly respected for his work on the limitations of conventional cannulas used for cardiopulmonary support, co-founded the company alongside Maya Bertron, renowned for his corporate finance experience, most notably in private equity and the initial public offerings of biotech and medtech companies.
Founded in 2021 with €5 million in funding from entrepreneurs and private investors, iPerf concentrates its resources on developing cutting-edge solutions aimed at improving the management of patients receiving cardio‑pulmonary support.
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iPerf
