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The EMBOL-X Aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 60 years and older undergoing first time non-emergent CABG or isolated aortic or mitral valve repair/replacement.

The EMBOL • X Aortic Filter device consists of three primary components: 1.) a distal heparin-coated mesh filter, mounted onto a flexible frame to form a filter basket for particulate emboli capture and retention; 2.) a locking cartridge housing for attachment to the EMBOL•X Aortic Cannula side port, permitting access to the aorta and to ensure correct orientation of the filter during use; and 3.) a proximal syringe-like plunger mechanism to deploy and withdraw the distal basket into and from the aorta, via the cannula, during surgery. The filter is introduced surgically into the aorta via the previously placed cannula, and particulates are captured and removed as blood passes through the filter basket. The filter may remain in situ for up to 60 minutes. The EMBOL.X Aortic Filter utilizes conventional medical grade materials and processes, and is provided packaged, labeled, and sterile, intended for single-use.

The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

The EMBOL-X® Aortic Cannula consist of a standard 3/8" ID wire reinforced tube body having a curved J-tip end and a flange for suture attachment. Attached to the side of the J-tip end is an Introducer port having a single lumen housing and a removable self-venting keyed snap-lock Obturator. The outer portion of the J-tip includes a radiused groove that accepts the complimentary radiused distal end of the provided Obturator. With the Obturator inserted, the Obturator provides a smooth, minimally disruptive fit along the J-tip's radiused groove. Removal of the Obturator from the Introducer port reveals a channel through which a physically compatible device may be introduced through the Introducer's hemostatic valve and along the groove of the J-tip. The Introducer port acts as an intravascular hemostasis conduit that can accommodate the introduction of intravascular devices with an exit diameter ranging from 12 FR to 14 FR in size. The Obturator is removed only when intravascular access with a device is necessary. The EMBOL-X Aortic Cannulas have an insertion diameter size of 24 FR. All models are a J-tip configuration whose tips are made from metal or plastic. The device is packaged sterile and non-pyrogenic, is single use only, and come with a separate optional use porous vent plug for cannula venting.

The EMBOL-X Aortic Occlusion and Cardioplegia Cannula is intended for use during cardiopulmonary bypass (CPB) procedures to: (1) occlude the ascending aorta, (2) deliver cardioplegia solution, and (3) vent the aortic root.

The EMBOL-X Aortic Occlusion and Cardioplegia Cannula consists of a twolumen cannula with three lines and an elastomeric balloon mounted on a 14 French tip. The first cannula lumen is used to inflate the balloon. The inflated balloon occludes the ascending aorta, partitioning the aortic root from the remainder of the arterial circulation. The balloon is expandable to occlude a range of aortic diameters. A two-way stopcock maintains the inflation and deflation of the balloon. The second cannula lumen is attached to two separate lines. The first line is used to deliver antegrade cardioplegia solution, and the second line is used for venting the aortic root. A sliding flange, located at the base of the cannula hub, adjusts to accommodate for varying aortic diameters and assists in anchoring the device during use.