Minimally Invasive Support Device Earns CE Mark

Reed Miller


September 06, 2012

September 5, 2012 (Aachen, Germany) — Circulite's Synergy minimally invasive circulatory support system will soon be available in Europe, now that European regulatory authorities have granted it a CE Mark, the company announced [1].

The device, about the size of an AA battery, can circulate up to 4.25 L of blood per minute. It is implanted into a subcutaneous pocket and supports circulation through small intercostal openings. Its designers expect it to be implanted in patients with heart failure who need circulatory support but are unsuitable for a complete left ventricular-assist device (LVAD), either because their condition isn't severe enough to warrant the risks of an LVAD (INTERMACS scores 4-6, NYHA class 3B) or because the patient is too small to accommodate one.

The company says it is "moving forward aggressively" to bring the Synergy to the US market and is in discussions with the FDA to initiate a trial in the US by early 2013.

The CE Mark was based on results from 44 patients in a multicenter trial. A total of 59 patients have received the device in the trial at nine European centers [2]. At the International Society for Heart and Lung Transplantation (ISHLT) meeting in Prague in April, Dr Bart Meyns (Gasthuisberg University Hospital, Belgium) presented data from 50 patients. In the 28 patients who were examined with follow-up catheterization (median=13 weeks), cardiac index increased from an average of 2.2 L/min/m2 to 2.7 L/min/m2 (p < 0.001) and showed reductions in capillary wedge pressure from an average of 27.1 mm Hg to 17.5 mm Hg (p < 0.001). The trial subjects also showed significant increases in exercise tolerance, functional status, and quality of life.

More Synergy trial data will be announced at the upcoming Heart Failure Society of America 2011 Scientific Meeting in Seattle, WA, held from September 9 through 12.