TEANECK, N.J.--(BUSINESS WIRE)--CircuLite®, Inc. today announced 90-day results for the final 26 patients in its CE Mark Trial of the SYNERGY® Circulatory Support System, which were discussed in an oral presentation Saturday at the 33rd Meeting of the International Society for Heart and Lung Transplantation (ISHLT) in Montreal, Canada. The patients were implanted with the final, commercial version of the SYNERGY 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 last 26 consecutive patients in the CE Mark Trial – out of the total 63-patient trial set – were treated with the optimized SYNERGY System. 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.”
The SYNERGY System was also featured in one additional oral presentation and two poster presentations at ISHLT. The oral presentation and one poster featured animal studies of an investigational right heart application of the SYNERGY System to treat pulmonary arterial hypertension, which demonstrated that right ventricular support may improve both systemic and pulmonary hemodynamics. The other poster presentation reviewed an animal study of an investigational endovascular implantation of the SYNERGY System, which demonstrated the feasibility of deploying a novel Inflow Cannula transseptally, via venous access to the left atrium for implantation with no complications.
The minimally-invasive SYNERGY System is the world’s smallest, commercially-available circulatory support pump – approximately the size and weight of a AA battery. It is designed to work in synergy with the native heart to improve blood flow to the brain and body, rather than replace the heart’s function.
SYNERGY received CE Mark in September 2012 and is currently conducting a controlled commercial rollout in Europe.
About the SYNERGY® Circulatory Support System
The SYNERGY Circulatory Support System is a micro-blood pump that provides up to 4.25 liters of blood per minute and reduces the heart’s workload, while improving blood flow to the final organs. The system is surgically implanted using a mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket. The system’s less invasive procedure is intended to reduce the surgical risks associated with cardiopulmonary bypass support. In addition, SYNERGY is intended to reduce rehospitalizations associated with heart failure symptoms. SYNERGY is designed and manufactured in Aachen, Germany.
CircuLite is developing disruptive solutions to improve the treatment of heart failure. The Company’s technologies work in conjunction with the heart to enhance clinical outcomes and improve quality of life. SYNERGY, which received CE Mark in 2012, features the smallest surgically-implanted blood pump for long-term use in ambulatory chronic heart failure patients not responding to optimal medical treatment. The company is developing a portfolio of minimally-invasive systems based on its proprietary micro-pump platform, including an endovascular system, a right-heart system and a pediatric system. For more information, visit our website at www.circulite.net.
CAUTION: Investigational Device. Limited by United States Law to Investigational Use Only.
CircuLite® and SYNERGY® are registered trademarks of CircuLite, Inc. in the United States.