News | March 30, 2009

CircuLite Demonstrates Long-Term Improvements, Hemodynamic Benefits with Synergy Partial Circulatory Support

March 30, 2009 – At ACC 2009, CircuLite Inc. today presented positive clinical data for its Synergy Pocket Micro-pump for chronic heart failure.

The data demonstrates that long-term, partial circulatory support with Synergy yielded statistically significant hemodynamic benefits and sustained improvements in cardiac function with evidence of myocardial recovery in patients with chronic heart failure. The presentation was given by Daniel Burkhoff, M.D., Ph.D., chief medical officer of CircuLite and Adjunct Associate Professor of Medicine at Columbia University Medical School.

Synergy is a micro-blood pump, the size of a AA battery, that can be implanted superficially in a “pacemaker-like” pocket. Synergy is the first and smallest device designed for partial circulatory support (up to 3L/min) and long-term use in patients with Class IIIb and early Class IV heart failure.

“These data show that partial circulatory support with the Synergy device effectively unloads the heart and can interrupt the progressive hemodynamic deterioration that typically occurs in the later stages of chronic heart failure,” said Dr. Burkhoff. “We are particularly encouraged with the finding that patients in this study showed signs of myocardial recovery, suggesting that treatment with this device can yield long-term improvements in clinical status and quality of life, not only in hemodynamic parameters as we have now shown. A smaller, less-invasive device like Synergy could expand the eligible patient population for circulatory support devices and may address the limitations of left ventricular assist devices, which are associated with a major surgery and significant adverse events.”

“Synergy represents a new approach to mechanical circulatory support, which we believe may be a breakthrough in chronic heart failure management by enabling earlier, less-invasive treatment for more patients,” said Paul Southworth, president and CEO of CircuLite. “We are excited by the impressive results emerging from our ongoing study of the long-term use of Synergy and believe that the data support our ultimate goal for the device, which is long-term, partial support in patients with Class IIIb/IV chronic heart failure. We look forward to receiving CE Mark approval and our commercial launch of Synergy in Europe later this year.”

Synergy is limited to only investigational use at this time.

The presentation details results for 16 patients (13 males) who were implanted with Synergy. Significant improvements in hemodynamics were observed in the first day of support. Additionally, 8 patients have since completed their follow-up right heart catherization at a mean of 11 weeks, and the data demonstrate that the significant hemodynamic improvements were sustained. Mean arterial pressure increased from 68 mmHg to 81 mmHg (p=0.02) and mean cardiac index increased from 2.0 to 2.8 L/min/m2 (p=0.01). Large reductions in mean capillary wedge pressure were observed (29 to 17 mmHg, p=0.003). In addition, mean peak VO2 increased from 9.6 to 14.1 ml/kg/minute. The duration of patient support with Synergy averaged 90 days, with the longest support period of 213 days. At three months, 81 percent (13/16) of patients were alive and nine received heart transplants. No device related deaths or strokes have occurred.

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