CircuLite®, Inc. has announced 90-day results for the final 26 patients in its CE Mark Trial of the SYNERGY® Circulatory Support System. The patients were implanted with the final, commercial version of the system, which demonstrated clinically meaningful and sustained hemodynamic improvements, with a relatively low rate of adverse events when compared with larger support devices.
The SYNERGY System is the world’s smallest circulatory support pump and is designed to reverse the symptoms of heart failure in ambulatory chronic heart failure patients via a minimally-invasive procedure. The system is surgically implanted using a mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket. The less invasive procedure required to implant this device is intended to reduce the surgical risks associated with cardiopulmonary bypass support.
We most recently covered the news, in March of this year that the FDA had issued conditional approval for CircuLite to commence its pivotal US regulatory trial.
The new announcement relates to results which were discussed in an oral presentation last Saturday(April 27th) at the 33rd Meeting of the International Society for Heart and Lung Transplantation (ISHLT) in Montreal, Canada.
The last 26 consecutive patients in the CE Mark Trial – out of the total 63-patient trial set – were treated with the most recent iteration of the Synergy device.
Ninety-day follow-up from these non-inotrope dependent INTERMACS ≥4 patients showed significant hemodynamic improvements, including decreased pulmonary artery and pulmonary capillary wedge pressures, and increased cardiac output. Peak VO2, the six-minute walk test and the Minnesota Living with Heart Failure Questionnaire also demonstrated significantly improved functional status and quality of life.
Major adverse events, such as bleeding, infection and stroke, trended lower than published studies of larger support devices.
“The latest version of the SYNERGY System was shown to improve hemodynamics and functional status with comparably low adverse event rates in chronic ambulatory heart failure patients,” concluded Bart Meyns, MD, PhD, Professor and Chief of Cardiac Surgery at the University Hospitals Leuven, Belgium, who presented the study. “The System has the potential for broad application in earlier-stage patients, who are not sick enough to justify the risks associated with more surgically-invasive assist devices.”
“The final modifications we made to the SYNERGY System have made a significant clinical difference, which was demonstrated in our clinical trial,” said Paul Southworth, Chief Executive Officer of CircuLite. “We showed positive outcomes and we have lowered adverse events in comparison to larger devices.”
Synergy received CE Mark in September 2012 and is currently conducting a controlled commercial rollout in Europe. Investigational Device. Limited by United States Law to Investigational Use Only.
Source: CircuLite, Inc.