Orqis Medical has enrolled the first patient in the MOMENTUM pivotal trial of its Cancion CRS cardiac recovery system, according to Medical Director Marvin Konstam, MD, Tufts-New England Medical Center.

Speaking at the TCT 2004 conference in Washington, D.C., Konstam, who is also president of the Heart Failure Society of America, introduced the planned 200-patient trial. Orqis is working with FDA to finalize trial details, including the precise number of patients and length of follow-up. The study will support a PMA submission for an acute decompensation heart failure indication.

Patients will be randomized to either the Cancion and medical therapy or medical therapy alone. The primary endpoint will be a "composite of change of wedge pressure and a clinical response in terms of days alive out of the hospital," Konstam said.

The "rest-to-recovery" device reduces ventricular pressure by diverting blood from the femoral artery into a rotary pump, then into the descending artery (¹ Also see "Orqis Cancion Is First “Parallel” Cardiac Assist Device, Firm Says" - Medtech Insight, 22 July, 2002., p. 21).

Inclusion criteria will include "presence of inotropic therapy with inadequate clinical response and elevated wedge pressure, low cardiac index and evidence of either modest increase in creatinine and/or high levels of intravenous diuretics," Konstam stated.

Although Cancion has been CE-marked in Europe since 2002, the firm is marketing the device conservatively, citing a lack of clinical data. Because Cancion does not connect directly to the heart, European trials were not required. Orqis plans to launch a marketing program using U.S. pivotal data.

The firm also is considering additional indications in Europe, noting that other benefits besides treating acute decompensation heart failure derive from resting the heart.

A 24-patient U.S./EU feasibility trial in which patients were treated with Cancion for 72 hours found "a decrease in pulmonary capillary wedge pressure, an increase in cardiac output, sustained or increased hemodynamic effects 24 hours after removal...improvement in renal function [and] reduction in BNP."

Orqis Begins Cancion Therapy Trial Enrollment, Mulls Future Indications

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