Engineering Minimally Invasive Technology for Important, Unmet Healthcare Needs

Technology

The V-Wave Ventura® Interatrial Shunt System

The V-Wave Ventura Interatrial Shunt is a novel, hourglass-shaped implantable device.  The shunt is designed to enable shunting of blood across the interatrial septum.

The Ventura Interatrial Shunt
Demonstrated for left-sided heart failure

The Ventura Interatrial Shunt
Demonstrated for left-sided heart failure

Designed for Venturi Fluid Dynamics

The novel hourglass design of the Ventura Interatrial Shunt is engineered to create a venturi tube-like effect from the high-pressure atrium to the low-pressure atrium.  This effect increases the efficiency of blood transfer, permitting a smaller size shunt.

Novel Design Features

Nitinol Hourglass Frame: designed to securely anchor the shunt to the fossa ovalis, preventing migration or embolization of the shunt device.

Biocompatible ePTFE Encapsulation: designed to limit tissue growth and maintain device patency.

The Procedure

The V-Wave Ventura Interatrial Shunt is implanted across a patient’s interatrial septum using a right-sided femoral catheterization procedure.  The procedure is conducted with fluoroscopic and echocardiographic guidance (TEE and/or ICE). After crossing the wall between the left and atrium by transseptal catheterization, the compressed Ventura Interatrial Shunt device is delivered across the septum and its release is controlled such that its hourglass shape holds it firmly in place.

To support implantation, physicians will use the Ventura Delivery System and an introducer sheath during the procedure.

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CAUTION

The V-Wave Ventura Interatrial Shunt System is an investigational device, limited by Federal U.S. law to investigational use.  To be used by Qualified Investigators only.

MP0009 Rev. 00 DCO 670.