Historically, the market for heart failure devices has gone to extremes. At one end of the spectrum, there are drugs, which manage the symptoms of patients in earlier stages of the disease, and at the other end, there are surgically implanted left ventricular assist devices (LVADs) and artificial hearts, to support patients in end-stage heart failure while they wait for a heart transplant. There is a large group of chronic heart failure patients in the middle—more than two million of them worldwide—who are resistant to or have failed drugs or devices, and are therefore bereft of helpful therapeutic options. Back in 2006, when START-UP first spoke with CircuLite Inc., CEO Paul Southworth explained that his company was after those patients, with a small pump that, in providing partial circulatory support, would be in an entirely different category than LVADs. (See CircuLite Inc., START-UP, July 2006 Also see "CircuLite Inc." - Medtech Insight, 1 July, 2006.).
Today, on only a bit more than $36 million in funding, CircuLite has developed the Synergy Pocket Micro-pump, a tiny pump designed to provide partial assist to the heart. [See Deal]Synergy has completed its first-in-man study, and is nearing completion of its European clinical trial supporting a CE mark