At the 33rd Meeting of the International Society for Heart and Lung Transplantation, Circulite (Saddle Brook, NJ), maker of SYNERGY, the world’s smallest heart assist device, announced 90 day results of a 26 patient trial of the latest optimized, commercial version of the device.
The SYNERGY was approved last year in Europe and is going through IDE trials in the U.S.
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 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.
Here’s animation showing the implantation procedure:
Flashbacks: SYNERGY Blood Pump from CircuLite Gets IDE Approval to Begin Clinical Trial; SYNERGY Mini Heart Assist Pump from CircuLite Now Cleared in Europe; First Implantation of Circulite’s Synergy Mini Blood Pump; Synergy Pocket Circulatory Assist Device Does Well in Early Trial
Product page: SYNERGY ventricular support system…
Press release: Optimized SYNERGY(R) Circulatory Support System Achieves Positive Outcomes in CE Mark Trial
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