Updated on 2 December 2013
The system is currently undergoing an upgrade to resolve issues that arose post commercial release. Surgical system sales are expected to resume in a controlled fashion following regulatory approval to re-launch the system in Europe and will focus on building experience at a small number of centers of excellence, refining training techniques and implementing additional system upgrades in advance of a full rollout.
"The Synergy system is a novel entrant in the partial-support space for treating patients with earlier stage heart failure," said Dr Martin Strueber, of the University Heart Center Leipzig in Leipzig, Germany. "To date, there is no viable option for those patients who have used biventricular pacemakers without success and who are not yet sick enough for a VAD or cardiac transplantation."
Dr Strueber also said, "Having implanted Synergy systems and witnessed the marked benefits to my patients and increased referrals I received for both full and partial mechanical support, I look forward to technological advancements to the system and a restored availability for patients. Longer-term, the endovascular approach, which we have explored extensively in Leipzig in partnership with our cardiology colleagues, is truly exciting and holds considerable promise."
"We are confident that HeartWare's technical, regulatory, sales and marketing capabilities will have a profound impact on enabling the Synergy system to reach its full potential," said Dr Daniel Burkhoff, chief medical officer at CircuLite. "There is considerable opportunity for the current Synergy system, and through continued investment and innovation, we believe we could expand the circulatory support market with the launch of a groundbreaking, endovascular treatment for patients with earlier stage heart failure."
"The team at CircuLite created the Synergy endovascular system in collaboration with several leading cardiologists and received approval to commence a feasibility study earlier this year. We look forward to commencing an investigation of this elegant device, as we believe it has the potential to vastly expand the mechanical support market by bringing cardiologists into the implant procedure for the first time," Mr Godshall added.