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.

For more information: www.CircuLite.net

Related Content

A view of the EPD Solutions catheter ablation system image guidance. It displays the catheter within a pre-acquired 3D segmented CT image. The D700 system provides a real-time lesion assessment tool that predicts transmurality and permanency of lesions, pre- and immediately post-ablation.

A view of the EPD Solutions catheter ablation system image guidance. It displays the catheter within a pre-acquired 3D segmented CT image. The D700 system provides a real-time lesion assessment tool that predicts transmurality and permanency of lesions, pre- and immediately post-ablation.

News | EP Lab | June 05, 2018
June 5, 2018 — Philips Healthcare has signed an agreement to acquire EPD Solutions, a provider of image-guidance in c
A recent study shows the Baylis NRG radiofrequency (RF) Transseptal puncture catheter has a lower incidence of embolism in EP cases.
News | EP Lab | May 21, 2018
May 21, 2018 — A recent study published in Heart and Vessels has found that the use of the Baylis Medical NR
Myocarditis is an Under-recognized Etiology of Symptomatic Premature Ventricular Arrhythmia (PVCs). #HRS #HRS2018
News | EP Lab | May 18, 2018
May 18, 2018 — A significant number of patients with symptomatic premature ventricular contractions (PVCs) have under
Novel Antibiotics Can Help Lower EP Device Infection Rates. Pictured here is an ICD. Implantation of pacemakers, ICDs and the related cardiac leads opens patients to infection risk.

Implantation of pacemakers, ICDs and the related cardiac leads opens patients to infection risk.

News | EP Lab | May 17, 2018
May 10, 2018 – A new study is the first to test the clinical effectiveness of incremental peri-operative antibiotics
The Apple Watch Series 2, Samsung Galaxy Gear S3 and the Fitbit Charge 2 were all able to properly diagnose the very rapid heart beats involved in  paroxysmal supraventricular tachycardia (PSVT). #HRS2018

The Apple Watch Series 2, Samsung Galaxy Gear S3 and the Fitbit Charge 2 were all able to properly diagnose the very rapid heart beats involved in  paroxysmal supraventricular tachycardia (PSVT).  

News | EP Lab | May 16, 2018
May 16, 2018 — A new study is the first to validate the accuracy of wrist-worn wearable devices in measuring induced
LivaNova Completes Sale of Cardiac Rhythm Management (CRM - electrophysiology) Business to MicroPort Scientific
News | EP Lab | April 30, 2018
April 30, 2018 — LivaNova announced it completed the sale of its cardiac rhythm management (CRM) business to MicroPor
LivaNova Enters Binding Letter of Intent to Sell Cardiac Rhythm Management Business
News | EP Lab | January 26, 2018
January 26, 2018 — LivaNova PLC and MicroPort Scientific Corp.
Societies Detail Treatment for Patients With Ventricular Arrhythmias
News | EP Lab | October 30, 2017
The American College of Cardiology, along with the American Heart Association and the Heart Rhythm Society, published...
Baylis Medical and Siemens Co-Sponsor Transseptal Access Training Course
News | EP Lab | October 18, 2017
Baylis Medical Co. Inc. and Siemens Healthineers are co-sponsoring a first-of-its kind training program aimed at...
Spectranetics Initiates Class I Recall for Bridge Occlusion Balloon Catheter
News | EP Lab | September 27, 2017
Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in...
Overlay Init