MC3 Cardiopulmonary (mc3corp.com), The ECMO Company™, announces FDA clearance for the Nautilus™ portfolio of products for use in ECMO.
MC3’s Nautilus™ Smart ECMO Module used for extracorporeal life support procedures in patients requiring respiratory and/or cardiopulmonary support. The device oxygenates blood, removes carbon dioxide, regulates blood temperature and provides real-time hemodynamic data analytics. It’s the first device that combines the capabilities of a long-term, plasma-tight Polymethylpentene (PMP) hollow fiber ECMO oxygenator and the integration of real time, at-a-glance-enabled hemodynamic monitoring into one disposable life-support device.
The Nautilus™ Module connects to most component-based blood pumps. Blood enters the device and passes through both the heat exchange membrane—where temperature is adjusted—and the gas transfer membrane—where oxygen is added, and carbon dioxide is removed. The device contains integrated sensors with an electronic touch screen display and a status bar that enables vital, at-a-glance monitoring of hemodynamic device health parameters.
“ECMO technology is advancing rapidly, and clinicians are finding clinical value in its capability to provide life support for select patients, deemed candidates, after traditional therapies such as mechanical ventilation have failed,” said Scott Merz, CEO of MC3 Cardiopulmonary. “Due to the disposable nature of the Nautilus™ Smart ECMO Module, we can connect it with virtually any component-based blood pump used in ECMO to provide state-of-the-art support and data monitoring for a versatile user base.”
The FDA clearance of the Nautilus™ portfolio of products, follow the CE Mark and launch of the Nautilus™ devices in Europe and the CE Mark and FDA clearance and launch of MC3’s Crescent® Dual Lumen Catheter for VV ECMO and the Opus™ Vascular Access Kit. The Crescent® catheter was the first device cleared by the FDA for ECMO in the United States. MC3’s portfolio of ECMO products are distributed by Medtronic.
MC3 today announced the launch of the Crescent® Jugular Dual Lumen Catheter, the first such device cleared by FDA for ECMO (Extracorporeal membrane oxygenation) in the United States.
MC3’s Crescent catheter is placed through the jugular vein and is connected to an ECMO system, which removes carbon dioxide and reinfuses oxygenated blood. Crescent’s unique design permits unmatched flow performance, minimizes recirculation and enables smooth insertion, visible location, and highly durable placement.
“There is an under-served population suffering with lung failure around the world, and the introduction of our Crescent catheter means new options for clinicians and their patients,” said Scott Merz, CEO of MC3 Cardiopulmonary.
“Until recently, mechanical ventilation with intubation was the last line of defense for millions of patients around the world each year. Due to the advancements in technology available in Crescent, we can now consider cannulating the sickest of these patients instead of intubating them. Crescent is the lifeline between the patient and the ECMO system, and we believe vascular access is one of the most important technology segments in healthcare today. Our shared vision with the clinical community is to take standardized ECMO care from possibility to reality.”
Indication for Use
The Crescent Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
MC3 Cardiopulmonary today announced it has completed the acquisition and transfer of all assets associated with Terumo Cardiovascular’s previously marketed Surgical Cannula line, including leading brand names like Sarns™ Soft-Flow® Arterial Cannula.
Founded in 1991, as a spinout of the University of Michigan, MC3 is well known within the medical community as a pioneer in heart/lung extracorporeal life support research. The acquisition marks a major milestone in the Company’s goal to transform into a global cardiopulmonary medical device manufacturer.
“This is a significant milestone for us, and we are excited to return the legacy of Soft-Flow® Arterial Cannula to the users and patients it will serve,” said Scott Merz, CEO of MC3 Cardiopulmonary. “In order to support our goals as a global medical device company, we have built a world-class facility just outside of Ann Arbor in Dexter, Michigan. The location provides close proximity to the University of Michigan, Detroit International Airport and skilled know-how within our sector.”
The Terumo Surgical Cannula was once one of the largest cardiac surgery cannula lines in the world, offering more than 200 product SKUs. The flagship product, the Soft-Flow® Arterial Cannula was the world’s first dispersion tip aortic cannula and remains a favorite among clinical users worldwide.
MC3 Cardiopulmonary announced today a distribution agreement with Medtronic, giving the global healthcare company exclusive worldwide distribution rights to MC3’s Soft-Flow arterial cannula globally.
The partnership will mean the return to market of the world’s first diffusion tip arterial cannula, which enables caregivers to provide gentle perfusion of the aorta during cardiopulmonary bypass procedures.
“Soft-Flow was once the top-selling arterial cannula in the United States and it remains a favorite among surgeons and perfusionists nationwide. We are very pleased to have this opportunity to partner with Medtronic to bring Soft-Flow to the global market,” said Scott Merz, President and CEO of MC3 Cardiopulmonary. “Medtronic’s established depth in the cardiovascular market will help ensure outstanding product distribution and support for a surgical community ready to put this important cannula product into use.”
Soft-Flow, the first product launch for MC3 Cardiopulmonary, is expected to be followed by a portfolio of new products designed to support patients with cardiopulmonary dysfunction. This aligns with MC3’s mission to serve the global community by creating life restoring medical devices that address acute and chronic unmet cardiopulmonary clinical needs.