CircuLite receives approval for CE mark trial for Synergy IC circulatory support system


CircuLite has 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. According to the company, it is the first mechanical support system that does not require major surgery. The Synergy system is based on the surgical Synergy system, which according to the company is the world’s smallest commercially available circulatory support pump, and is designed to treat ambulatory chronic heart failure patients (INTERMACS ≥4).

In a press release, the system was described as a superficially placed micro-pump platform surgical system, with 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, chief medical officer of CircuLite and adjunct associate professor of medicine at Columbia University Medical School, USA. “If successful, this approach will usher in a new era in mechanical circulatory support, much the same way transcatheter aortic valve implantation (TAVI) did for aortic valve replacement.”

The multicentre CE mark trial is expected to enrol 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 are intended to be assessed post-implantation. Patient screening has commenced at the University Hospitals Leuven, Belgium, according to the company release.

“With an even less invasive, interventional procedure performed in the cath lab or hybrid operating room, 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 Synergy system at EuroPCR (21–24 May, Paris, France) in the Cardiovascular Innovation Pipeline—Novel Interventional Approaches for Heart Failure session, which will be held on Thursday, 23 May 2013 from 15:40 to 16:40 in Room 352A of the Palais des Congrés in Paris.

The surgical Synergy system received CE mark in September 2012 and is commercially available in Europe.