Thoratec Corp. has replaced CEO Gary Burbach with the man who previously led the company for a decade.
New president and CEO Keith Grossman served in those roles at the Pleasanton, CA–based company from 1996 to 2006, when Burbach took over. The shakeup follows the deaths of four patients and reduced blood flow or lost consciousness in five others while using the company's HeartMate II left ventricular assist device. The company and the FDA said the device was not at fault; rather, it was patients' misunderstanding of how to use a new controller.
The company announced in March its plans to update labeling and training materials for the HeartMate II LVAS Pocket System Controller because some patients and caregivers had trouble with the process of changing from a primary system controller to their backup system controller.
Of these nine cases of death or serious injury, eight occurred in patients who began using the Pocket Controller after having been trained on an older model, the EPC System Controller, according to a Qmed report. Two of the deaths involved patients who attempted to exchange system controllers while alone and, contrary to the labeling, without contacting the hospital first.
Thoratec announced the release of an updated version of the Pocket System Controller on September 18. The company said it would provide the latest version free of charge to cardiac centers and patients upon request. The exchange could cost it up to $11 million pretax in the third quarter.
In August, Thoratec's stock fell to a six-month low of $24.05, after having peaked in July at $24.71. It has slowly regained momentum, with an uptick to $27.74 following the announcement of Grossman's return.
Burbach left his executive and board roles but will remain an advisor to the company through the first quarter of 2016, according to a Thoratec statement.
Grossman has worked in the healthcare industry for 30 years, most recently as president and CEO of Conceptus, Inc. The Mountain View, CA–women's health medical device company's market value tripled as its sales and profits grew during Grossman's tenure, Thoratec said. Bayer Healthcare LLC purchased Conceptus in 2013.
During Grossman's previous turn at Thoratec's helm, the company made advances in the mechanical circulatory support market, boosting revenues and market value significantly, the company said.
Grossman has continued to serve on Thoratec's board since leaving the company. From 2007 to 2011, Grossman was a managing director at private equity firm TPG, where he initiated and co-led the medical device venture investing effort, and served as a senior advisor to the firm's buyout fund.
