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

FDA Class I Recall Issued for Medtronic HeartWare HVAD Pump
News | Ventricular Assist Devices (VAD) | May 29, 2020
May 29, 2020 — Medtronic is recalling its HeartWare HVAD...
Abiomed Receives FDA PMA Approval for Impella 5.5 With SmartAssist
Technology | Ventricular Assist Devices (VAD) | September 27, 2019
Abiomed’s newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre...
CorWave Presents First Successful In Vivo 60-day Study of Neptune LVAD
News | Ventricular Assist Devices (VAD) | September 12, 2019
CorWave announced successful completion of its first 60-day preclinical study to evaluate its Neptune left ventricular...
Experts Caution Against Catch-all Assumptions About LVADs and Mitral Regurgitation

Paul Tang, M.D., Ph.D., a cardiac surgeon at Michigan Medicine’s Frankel Cardiovascular Center in the OR. Image courtesy of Michigan Medicine.

News | Ventricular Assist Devices (VAD) | August 20, 2019
Left ventricular assist devices (LVADs) have been shown to help leaky mitral valves that create significant...
FDA Confirms Impella RP is Safe and Effective
News | Ventricular Assist Devices (VAD) | June 12, 2019
 In a letter sent to healthcare providers, the U.S. Food and Drug Administration (FDA) validates that Abiomed’s Impella...
Impella SmartAssist Platform Launches at SCAI
News | Ventricular Assist Devices (VAD) | May 22, 2019
Abiomed announced that the Impella CP with SmartAssist will be commercially available beginning at the 2019 Society for...
FDA Approves Impella 5.0 and Impella LD Extended Duration of Use
Technology | Ventricular Assist Devices (VAD) | May 14, 2019
The U.S. Food and Drug Administration (FDA) has approved the expansion of Abiomed’s Impella 5.0 and Impella LD...
FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial
News | Ventricular Assist Devices (VAD) | May 02, 2019
Abiomed announced that, on April 26, the U.S. Food and Drug Administration (FDA) approved initiation of the ST-...
Cardiogenic Shock Survival Rates Improve in Three Years Since Impella FDA Approval
News | Ventricular Assist Devices (VAD) | April 05, 2019
Three years ago this week, Abiomed's Impella heart pump received U.S. Food and Drug Administration (FDA) premarket...