News | May 20, 2013

CircuLite to Begin CE Mark Trial for Synergy IC VAD

Synergy IC system specifically designed for interventional cardiologist cannula deployment

Synergy IC Circulatory Support System Circulite CE mark Trial

May 20, 2013 — CircuLite Inc. announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE mark trial of the Synergy IC Circulatory Support System, the first mechanical support system that does not require major surgery. The Synergy IC System is based on the surgical Synergy Circulatory Support System — the world’s smallest commercially available circulatory support pump — which is designed to treat ambulatory chronic heart failure patients (INTERMACS ?4).

While the Synergy IC Circulatory Support System uses the same superficially placed micro-pump platform as the surgical system, it is the first implantable circulatory support system whose Inflow Cannula is designed to be implanted by a cardiologist using standard interventional techniques. The procedure is designed to further reduce the invasiveness of implantation, and thereby reduce the rate and severity of adverse events.

“Imagine being able to implant a permanent mechanical support device in a patient with chronic heart failure without major surgery,” said Daniel Burkhoff, M.D., Ph.D., chief medical officer of CircuLite and adjunct associate professor of medicine at Columbia University Medical School. “If successful, this approach will usher in a new era in mechanical circulatory support, much the same way TAVR did for aortic valve replacement.”

The multi-center CE mark trial will enroll up to 20 patients, starting in Belgium and expanding to two additional European clinical sites. Clinical status, end organ function, exercise tolerance, functional capacity and quality of life will be assessed post-implantation. Patient screening has commenced at the University Hospitals Leuven, Belgium.

“With an even less invasive, interventional procedure performed in the cath lab or hybrid OR, we will be making the Synergy System more accessible, more convenient and potentially safer for patients,” said Paul Southworth, chief executive officer of CircuLite.

Burkhoff will be presenting an abstract on The Synergy IC System at EuroPCR in the Cardiovascular Innovation Pipeline — Novel Interventional Approaches for Heart Failure session, to be held on Thursday, May 23, 2013 in Room 352A of the Palais des Congrés in Paris.

Related Content

Reduced Device Clotting, Decreased Strokes Seen With HeartMate 3 at Two Years
News | Ventricular Assist Devices (VAD) | March 13, 2018
At two years of follow-up, severely ill patients with advanced heart failure who received a novel heart pump fully...
Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
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...
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
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
Henry Ford Hospital, Detroit Cardiogenic Shock Initiative, Impella pump, ACC.17 clinical study
News | Ventricular Assist Devices (VAD) | April 03, 2017
Hospitals can dramatically increase heart attack survival rates in patients suffering cardiogenic shock by providing...
Metro Detroit cardiologists, increased heart attack survival rate, Impella heart pump, Detroit Cardiogenic Shock Initiative
News | Ventricular Assist Devices (VAD) | March 09, 2017
Metro Detroit cardiologists from five health systems have joined together to increase residents’ survival rate from...
Impella 2.5 heart pump, high-risk PCI, HRPCI, acute kidney injury risk, AKI, Circulation Research study, Abiomed
News | Ventricular Assist Devices (VAD) | March 09, 2017
A new study published in Circulation Research finds use of hemodynamic support with the Impella 2.5 heart pump during...
Overlay Init