October 4, 2018—Teleflex announced that it has acquired Essential Medical, Inc., a privately held company based in Exton, Pennsylvania, that developed and commercialized the Manta vascular closure device.
The Manta device is designed for closure of large-bore arteriotomies after procedures utilizing devices or sheaths ranging in size from 10 to 18 F, with maximum outer diameters up to 25 F.
Teleflex advised that the Manta device is not approved for sale or distribution in the United States. The company anticipates FDA premarket approval of the Manta device in 2019.
Manta has received European CE Mark approval. In the CE Mark study, the Manta device demonstrated rapid and reliable hemostasis with its resorbable collagen-based technology and complication rates that were noninferior to surgical and suture-based closure methods. The study was published in March 2017 by Nicolas M. Van Mieghem, MD, et al in Journal of the American College of Cardiology: Cardiovascular Interventions.
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