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Classified in: Health
Subject: FDA

MC3 Cardiopulmonary Announces FDA Clearance of Crescenttm for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO)


DEXTER, Mich., Oct. 18, 2018 /PRNewswire/ -- MC3 (mc3corp.com) today announced the launch of the Crescenttm 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 underserved population suffering with lung failure around the world, and the introduction of our Crescent catheter means new options for surgeons 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 Crescenttm 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.

About MC3 Cardiopulmonary

MC3 Cardiopulmonary is a privately owned high growth medical device manufacturer located in Dexter, Michigan. MC3's mission is to serve the global community by creating life restoring medical devices that address acute and chronic unmet cardiopulmonary clinical needs. Crescent is the first FDA cleared device labeled with a long-term Extracorporeal Membrane Oxygenation (ECMO) indication in the United States. The Company's global sales channel is managed by its exclusive distributor, Medtronic.

SOURCE MC3 Cardiopulmonary


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