Barathi Sethuraman is Divisional Vice President, Global Clinical Affairs, Structural Heart at Abbott’s Medical Devices Division. In this role, Barathi has oversight of clinical evidence generation, clinical trial design and execution, and dissemination of clinical trial results for Structural Heart medical devices – devices that address mechanical problems in the heart including problems with a valve or a hole in the heart. She oversees a number of landmark clinical trials to advance Abbott’s Structural Heart therapies.
Barathi received a Ph.D. in Statistics from the University of California, Berkeley and a Masters degree in Statistics from the Indian Institute of Technology, Kanpur, India. She started her career as a statistician in at LifeScan (a Johnson and Johnson company) in 1998. In March 2000, she took a Senior Biostatistician role within the clinical affairs organization at St. Jude Medical’s Cardiac Rhythm Management division. Barathi left St. Jude Medical in Nov 2008 to join a startup called Evalve (now Abbott), a manufacturer of a novel percutaneous technology to treat mitral valve regurgitation (MitraClip). In this role she led the effort to bring the first-in-class MitraClip therapy to an FDA advisory panel meeting, and ultimately the first FDA approval of a novel treatment for patients suffering from mitral valve regurgitation. Barathi left Abbott in March 2014 to join Coherex, a start-up manufacturer of left atrial appendage closure devices, and returned to St. Jude Medical (now Abbott) in March 2015 as Vice President, Clinical Science. At St. Jude Medical, Barathi was responsible for the design and analysis of number of pivotal clinical trials to support FDA approval and led the effort to bring another novel technology, the Amplatzer PFO Occluder, to an FDA advisory panel meeting, which ultimately led to the first FDA approval of a novel treatment for patients who have a hole in the heart and have suffered a stroke. Now back at Abbott, Barathi is doing what she loves – overseeing the Structural Heart clinical affairs organization. She oversaw the completion and reporting of the COAPT trial (which was initiated under her previous role at Abbott) – a landmark trial of the MitraClip therapy in patients suffering from heart failure and mitral regurgitation. This trial led to the approval of the MitraClip therapy in heart failure patients suffering from mitral valve regurgitation. Barathi is a two-time recipient of Abbott’s Chairman award, the highest honor within Abbott.
Barathi is passionate about excellence in clinical trial design and execution. As a statistician, she regularly preaches the importance of design, execution and analysis of clinical trials to bring new therapies to patients across the world. Barathi keeps current with the continuously changing clinical trial and regulatory landscape. She is respected by physician key opinion leaders in the Structural Heart space and serves as an expert industry professional on panel discussions.
Barathi is a stickler for high quality documents that tell a story. She loves teaching and mentoring and getting people to give their best performance. With her two children grown up, Barathi finds time to read and do some volunteer work. Despite her very busy schedule, she finds time to exercise very regularly. She also loves learning languages and hopes to soon become fluent in German.
Barathi is a member of the American Statistical Association and Neythri (www.neythri.org), a global community of South Asian professional women.