TUCSON, Ariz.--(BUSINESS WIRE)--SynCardia Systems, LLC (www.syncardia.com), manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that Brian Brogie has joined the company as Vice President of Manufacturing and Facilities.
Brogie will oversee manufacturing of SynCardia’s product line, which includes the commercially approved 70cc SynCardia temporary Total Artificial Heart; the new, investigational 50cc Total Artificial Heart for smaller patients; the Companion 2 hospital driver for powering the Total Artificial Heart from implant until the patient stabilizes; and the Freedom® portable driver, a wearable power supply that allows clinically stable patients to be discharged from the hospital.
“Brian has more than 30 years of experience, skills and knowledge in manufacturing, project management, process improvement and supplier management,” said Michael Garippa, President and CEO of SynCardia. “His track record of success in highly regulated industries, including medical devices, pharmaceuticals and aerospace, will help ensure that we continue to provide hospitals around the world with the products they need, when they need them, to save the lives of patients with end-stage heart failure.”
Prior to joining SynCardia, Brogie served as Director of Manufacturing for Gilead Sciences, Inc., where he led a team responsible for manufacturing two injectable drug products and packaging 12 solid oral dose products. Among his most critical duties were ensuring Current Good Manufacturing Practice (cGMP) compliance, executing spending within a $24 million manufacturing budget and facilitating the introduction of new products to the company’s production line. Brogie previously held similar positions with Oso BioPharmaceuticals and BF Goodrich Aerospace.
“Working for SynCardia is a once-in-a-lifetime opportunity,” said Brogie. “No one else is doing what they do for heart failure patients, and it’s an honor to join the team.”
CAUTION -- In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by federal law to investigational use.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.