Inspira has completed the first real-world procedure of its extracorporeal blood circulation device at New York’s Westchester Medical Center.
The Israeli company’s Inspira Art100 system received 510(k) clearance from the US Food and Drug Administration (FDA) in 2024 and is indicated for use in cardiopulmonary bypass procedures.
Go deeper with GlobalData
Inspira said during the life support procedure Inspira Art100 provided effective heart and lung support by oxygenating and circulating the patient’s blood, and the patient was safely transitioned off afterward.
The system is designed to elevate declining oxygen saturation levels without mechanical ventilators and uses a technique whereby oxygen is added into the blood and carbon dioxide removed, with the enriched blood circulated back to patients during critical procedures.
It can also be used in conjunction with Inspira’s Hyla blood sensor, which provides real-time oxygenation therapy monitoring to aid clinicians in detecting tissue hypoxia and the early warning signs of other respiratory complications.
Dr David Spielvogel, section chief of cardiothoracic surgery at Westchester Medical Center stated that the system performed “exceptionally well” during its first critical life-support procedure.
“This successful first case represents a promising advancement in extracorporeal support technology that could benefit numerous patients requiring this level of care.
“We look forward to continuing and expanding our relationship with Inspira,” Spielvogel added.
Inspira Art100 has also been approved by the Israeli Ministry of Health’s medical devices and accessories (AMAR) division for use in extra-corporeal membrane oxygenation in addition to cardiopulmonary bypass procedures.
According to GlobalData analysis, the global mechanical circulatory support devices market is growing at a CAGR of 5.9% and is forecast to reach a valuation of around $1.4bn by 2033, up from $790m in 2023. Key players in this space include Abbott Laboratories and Jarvik Heart.
Resonating with Inspira’s plans to penetrate this market in the US, last year the company received its first order for the Inspira Art100 systems from Glo-Med Networks and partnered with Westchester Medical Center for the now completed validation procedure.
Inspira president Joe Hayon commented: “This first successful patient use of Inspira Art100 is a pivotal milestone for Inspira, validating the real-world potential of the Inspira Art100.
“We believe that the positive outcome at Westchester Medical Center sets the stage for broader adoption across leading hospitals.”
