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What is the MOMENTUM Clinical Trial?
MOMENTUM is an acronym for Multicenter Trial of the ORQIS Medical CRS for the ENhanced Treatment of CHF Unresponsive to Medical Therapy. The MOMENTUM Trial is a prospective randomized U.S. clinical investigation of the CANCION® System to treat chronic congestive heart failure (CHF) patients with acute decompensation who poorly respond to medical therapy.
The CANCION® System is being studied to see if patients who are poorly responsive to medical treatment will feel better and experience improved outcomes in response to treatment with this system. Specifically, the Trial is investigating the System’s impact on clinically meaningful outcomes including:
- Earlier hospital discharge
- Improved cardiac hemodynamics
- Improved Renal Function
- Improved Quality of Life
- Decrease in hospital readmissions
ORQIS® Medical received initial approval from the FDA for the MOMENTUM Trial in July 2004. In April 2005 the company received unconditional approval to begin enrolling patients in up to 40 hospitals throughout the US. This is the pivotal phase of clinical trials investigating the CANCION® System; upon successful completion of MOMENTUM Trial, ORQIS® Medical plans to submit for FDA approval of the System.
