Thoratec wins FDA nod for HeartMate controller

Thoratec won FDA approval for a new external HeartMate II controller.--Courtesy of Thoratec

Thoratec ($THOR) scored the FDA's blessing to market a next-generation controller for the HeartMate II implant, giving the company a user-friendly face for its market-leading left ventricular assist device.

HeartMate II Pocket Controller is lighter and more compact than earlier models, providing patients with visual alarms and on-screen instructions, plus a backup battery in case the device gets disconnected. Thoratec said its new controller has a single-side cable design, allowing it to be concealed easily in a patient's pocket.

"Patients are living for extended periods of time on HeartMate II support, either while they wait for a transplant or as a long-term, destination therapy," CEO Gary Burbach said in a statement. "The launch of the Pocket Controller provides an attractive option for these patients and advances Thoratec's mission, which is to improve the lives of individuals suffering from advanced heart failure."

Thoratec plans to start training U.S. implanting centers on the device next week, and then rolling the controller out to new patients and HeartMate II users who want an upgrade.

Thoratec's suite of HeartMate implants accounts for about 80% of company revenue each year, and the company has faced some sluggish demand over the past few months. Last quarter, revenue slipped 7% to $117.7 million, and HeartMate sales dropped 8% to $102.9 million. However, Thoratec is still projecting revenue to grow about 4% to $510 million on the year, driven by HeartMate's expansion throughout the U.S., Europe and Japan. 

All the while, Thoratec has remained a rumored M&A target, and major shareholder Oracle Investment Management has urged the company find itself a buyer, calling Thoratec an "undeniable" fit for Medtronic ($MDT) or St. Jude Medical ($STJ).

- read the announcement