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FDA grants 510(k) Clearance for Phasix™ ST Mesh with Echo 2™ Positioning System for Ventral Hernia RepairNov 19, 2019
FRANKLIN LAKES, N.J., Nov. 19, 2019 – BD (Becton, Dickinson and Company), a leading global medical technology company, today announced the U.S. Food and Drug Administration has granted 510(k) clearance for the Phasix™ ST Mesh with Echo 2™ Positioning System for use in abdominal hernia repair. Phasix™ ST Mesh with Echo 2™ is the only bioresorbable mesh with a removable positioning system designed to help simplify minimally invasive ventral hernia repairs.1
This new device combines two category-leading technologies, Phasix™ ST Mesh and the Echo 2™ Positioning System, into a single product.2 Phasix™ ST Mesh is comprised of a long-lasting, naturally derived bioresorbable mesh that includes a proven hydrogel barrier for intraabdominal placement.3,4 Phasix™ ST Mesh helps create a strong repair without the need for a permanent implant.3 The Echo 2™ Positioning System is a pre-attached deployment and positioning device that is designed to help facilitate accurate and consistent mesh placement in minimally invasive ventral hernia repairs.1
“Hernias are prevalent in the U.S. and worldwide, either as a result of naturally occurring weaknesses of the human abdominal wall or as a result of previous surgeries. While effective care options exist for patients, Phasix™ ST Mesh with Echo 2™ Positioning System works with the body to rebuild tissue while gradually and predictably remodeling the area of weakness to provide a more durable repair,” said Namir Katkhouda, M.D., FACS; Professor of Surgery (tenure) University of Southern California. “The availability of this technology offers an exciting new option for surgeons, allowing abdominal hernia repairs the potential to be completed with more precision and in less time.”
Preclinical testing demonstrated that Echo 2™ Positioning System may save up to 30% time during mesh placement compared to traditional flat mesh.5 Additional preclinical data demonstrated that Phasix™ ST Mesh helps enable rapid tissue ingrowth while providing twice the strength of other bioresorbable mesh.6
“With more than 50 years of experience in hernia repair, we are continuing to innovate and improve upon treatment options to ensure clinicians have access to the latest technology to treat their patients,” said Michael Garrison, worldwide president of Surgery at BD. “Phasix ST Mesh's promising results in the treatment of hernias, coupled with the deployment technology of the Echo 2™ Positioning System, has the potential to make this device the preferred choice for surgeons performing abdominal hernia surgeries.”
Phasix™ ST Mesh with Echo 2™ is commercially available in the United States. For more information, visit www.bd.com.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
For more information on BD, please visit bd.com.