Implantable heart pump maker HeartWare International recently announced that it has tapped a former Boston Scientific executive as its new chief medical officer, effective September 1.
Katrin Leadley, MD, was most recently chief medical officer at JenaValve Technology in Munich, Germany, where she spent the last three years leading the company’s clinical, regulatory, scientific and medical activities.
Leadley, who has 20 years of clinical and industry experience at life science firms, also spent eight years at Boston Scientific locations in San Jose, CA, and Munich. She most recently served as global senior medical director of clinical sciences at Boston Sci.
“Her knowledge of cardiovascular device trials and her relationships with many of our international key opinion leaders will enable her to begin making contributions immediately. … Katrin will help lead HeartWare through our next stage of clinical and commercial growth, as we advance our ongoing trials, initiate new studies and move toward obtaining regulatory approval of devices in our pipeline,” Doug Godshall, HeartWare’s president and CEO, said in a press release.
Leadly will succeed David Hathaway, MD, who has been CMO at HeartWare since 2008 and has decided to retire.
HeartWare's revenue for 2013 increased 87% to $208 million--reflecting the company's first year of commercialization in the U.S. First quarter 2014 revenue was up 35% year-over-year, to $66.5 million, even as the company continues to operate in the red amid its ramp-up.
The company has experienced some issues amid the growth, including an FDA warning letter that expressed concern over how Framingham, MA–based HeartWare apparently failed to verify or validate the effectiveness of corrective actions responding to 27 complaints between February 2010 and November 2013. The complaints included reports of two deaths and four serious injuries, related to HeartWare's Ventricular Assist Device (HVAD) system.
