News | March 06, 2008

Circulatory Assist Device Trial Enlists 20 Patients

March 7, 2008 – CircuLite has advanced its Synergy Pocket Circulatory Assist Device clinical program into a 20-patient trial, after completion of a first-in-man pilot study of Synergy in four patients, as the company seeks CE Mark approval in the European Union for long-term implantation of Synergy in heart failure patients.

Synergy is a micro implantable blood pump, the size of a AA battery, that can be implanted superficially in a pacemaker-like pocket. The device is engineered to provide long-term, partial circulatory support in patients with chronic heart failure.

The European registration trial is planned to enroll 20 patients with chronic heart failure and will evaluate the safety and patient quality of life improvements associated with device support of greater than six months. To-date, seven patients have been successfully implanted with the Synergy device. Six implants were performed by Bart Meyns, M.D., Ph.D., at Gasthuisberg University Hospital in Leuven, Belgium, the site of the first-in-man trial. One patient in the trial was implanted at Hannover Medical School in Hannover, Germany, by André Simon, M.D., managing doctor of the Thoracic Transplant Program, and Martin Strüber, M.D., director of the Thoracic Transplant Program. A third trial site, University Hospital in Münster, Germany, has completed training and is now screening patients for the CE Mark trial.

“We are pleased to have two new, highly respected European trial sites and surgical teams on board for Synergy’s clinical program,” commented Southworth. “The addition of these sites highlights the interest in, and need for, this type of device.”

CircuLite recently reported positive results from the European first-in-man pilot study, for which enrollment is now complete. Four patients were implanted with Synergy in this trial. These patients reportedly benefited from improvements in hemodynamics and were allowed to return to activities of daily living. All patients were said to have reached the primary endpoint of successful heart transplantation, with one patient supported for seven months.

For more information: www.CircuLite.net

Related Content

Sponsored Content | Videos | Cardiovascular Ultrasound| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD)| June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Italian Boy Becomes Youngest Patient Bridged to Transplant With SynCardia Total Artificial Heart

Andrei, 12, is the world’s youngest patient to be bridged to transplant with the SynCardia Total Artificial Heart. He is pictured after his heart transplant with his surgeon, Antonio Amodeo, M.D., at Bambino Gesù Children’s Hospital in Rome, Italy. Photo courtesy of Business Wire.

News | Congenital Heart| June 22, 2017
A 12-year-old boy at Bambino Gesù Children’s Hospital in Rome, Italy, has become the world’s youngest patient to be...
Abiomed Impella CP pVAD, third-generation CP
Technology | Hemodynamic Support Devices| June 12, 2017
June 12, 2017 — Abiomed Inc.
tandemLife Tandemheart priming tray cleared by FDA
Technology | Hemodynamic Support Devices| June 12, 2017
June 12, 2017 — TandemLife began its commercial launch of the TandemLife Priming Tray, a new product designed to simp
Sponsored Content | Videos | Cardiovascular Ultrasound| May 26, 2017
This video, provided in partnership with the American Society of Echocardiography (ASE), is titled "Intraoperative Tr
Impella CP study to investigate door to left ventricular unloading time
News | May 09, 2017
May 9, 2017 — The first patient has been enrolled in the U.S.
Heartware HVAD recall for its ventricular assist device from Medtronic
Feature | Ventricular Assist Devices (VAD)| May 05, 2017
May 5, 2017 — Medtronic Mechanical Circulatory Support is expanding its recall of its HeartWare Ventricular Assist De
the Impella pVAD improves survival, mortality in AMI heart attack with cardiogenic shock

Early use of the Impella percutaneous ventricular assist device prior to angioplasty may significantly improve survival for patients in cardiogenic shock.

Feature | Hemodynamic Support Devices| April 28, 2017 | Dave Fornell
Recent clinical study data presented at the American College of Cardiology (ACC) 2017 meeting show new treatment prot
Sponsored Content | Videos | Ventricular Assist Devices (VAD)| April 14, 2017
A discussion with William O'Neill, M.D., FACC, FSCAI, medical director of the Center for Structural Heart Disease at
Overlay Init