CircuLite (Saddle Brook, NJ) won the go ahead from the FDA, in the form of an Investigational Device Exemption (IDE), to begin a clinical trial of its SYNERGY Circulatory Support System. About the size of a AA battery, the pump moves oxygenated blood from the left atrium via an implanted canula to the subclavian artery. It is self cleaning and is powered by an external 2.2 pound (1 Kg) dual battery pack that has a 6- 8 hour life between recharges.
The implantation procedure is minimally invasive, not requiring a bypass or even opening the chest cavity, which will hopefully provide an option for otherwise difficult to treat terminal patients.
In a European CE Mark clinical study, SYNERGY was shown to improve hemodynamics, exercise capacity and overall quality of life in ambulatory chronic heart failure patients (INTERMACS ≥4 or NYHA Class III/IV).
With receipt of conditional IDE approval, CircuLite plans to commence its U.S. clinical trial evaluating the use of the SYNERGY Circulatory Support System for long-term support in ambulatory chronic heart failure patients (INTERMACS ≥4) who remain symptomatic despite optimal medical management. The IMPACT Trial (Safety EvaluatIon of the CircuLite SYNERGY Circulatory Assist Device in a Non-Inotrope Dependent, AMbulatory Patient with End-StAge Chronic Heart Failure: A PiloT Study) is a 20-patient feasibility trial that will be conducted at seven U.S. clinical sites.
Flashbacks: First Implantation of Circulite’s Synergy Mini Blood Pump; SYNERGY Mini Heart Assist Pump from CircuLite Now Cleared in Europe
Product page: SYNERGY…
Press release: CIRCULITE® RECEIVES CONDITIONAL IDE APPROVAL FOR SYNERGY® CIRCULATORY SUPPORT SYSTEM FEASIBILITY TRIAL