Circulite Demonstrates Long-Term Improvements and
Hemodynamic Benefits With Synergy® Partial Circulatory Support in Chronic Heart
Failure Patients
- Late-breaking Abstract Presented at 58th Annual Scientific Session of the
American College of Cardiology -
- AA battery-sized pump offers less-invasive alternative to full-support
LVADs -
ORLANDO, F.L. and SADDLE BROOK, N.J. (March 30, 2009) – CircuLite, Inc. today
announced the presentation of 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, at the 58th Annual Scientific Session of the American College of
Cardiology in the Late-Breaking Clinical Trials Emerging Technologies session.
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.”
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.
About Synergy®
The Synergy® Pocket Micro-pump represents a new approach to mechanical
circulatory support that is designed to transform chronic heart failure
management by providing a less-invasive, elective treatment option for patients
before their disease state becomes emergent. Synergy is the first implantable
system designed to provide partial circulatory support (PCS) for long-term use
in millions of unserved patients that have NYHA Class IIIb/early IV disease.
CircuLite’s patented micro-pump provides up to 3L/min of flow, which increases
total cardiac output, offloads the heart, allowing it to rest, and potentially
enables beneficial recovery of heart function. The size of a AA battery, the
device is small enough to be implanted subcutaneously in a “pacemaker-like”
pocket through a minimally-invasive procedure.
About CircuLite®
CircuLite is transforming heart failure treatment with the development of
minimally-invasive devices for long-term partial circulatory support (PCS). By
enabling a proactive and lower-risk treatment approach by supplementing a
patient’s native pumping capacity, CircuLite has the potential to improve the
quality of life for millions of chronic heart failure patients and their
families. CircuLite’s pipeline of PCS devices is lead by the Synergy® Pocket
Micro-pump, the world’s smallest implantable blood pump currently in a CE Mark
clinical trial. Next-generation Synergy micro-pumps include an endovascular
system, a fully-implantable system and a pediatric system. For more information
on CircuLite and the Synergy Pocket Micro-pump devices, visit our website at
www.CircuLite.net.
Contact
Media:
Kari Watson or Jennifer Conrad
MacDougall Biomedical Communications
kwatson @macbiocom.com
jconrad @macbiocom.com
(781) 235-3060
CAUTION: Investigational Device. Limited by Federal Law to Investigational Use
Only.
CircuLite® and Synergy® are registered trademarks of CircuLite, Inc. in the
United States.
