GORE CARDIOFORM User Manual Manual

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GORE® CARDIOFORM Septal Occluder Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in complications. DESCRIPTION The GORE® CARDIOFORM Septal Occluder consists of an implantable Occluder and a Delivery System. The Occluder is compris ...

not been studied in, patients with other anatomical types of ASDs that are eccentrically located on the septum (e.g. sinus venosus ASD and ostium primum ASD), or fenestrated Fontan. • The GORE® CARDIOFORM Septal Occluder has not been studied in patients with multiple defe ...

non-randomized, Pivotal Study that included 50 subjects. An Independent Data Reviewer provided external oversight and review of subject safety data, including evaluation of all reported adverse events for accuracy of event coding, seriousness, and relatio ...

arterial pressure unless the indexed pulmonary arteriolar resistance was <5 Woods units. • Multiple defects based on screening imaging and stop-flow balloon sizing that would require placement of more than one device. Subjects provided informed consent prior to enrollment. No ...

Study Number of Subjects 50 Patient Demographics Gender Male 23 (46.0%) Female 27 (54.0%) Race Black or African American 8 (16.0%) White or Caucasian 39 (78.0%) Other Race 4 (8.0%) Age (years) N = 50 Mean (Std Dev) 19.7 (21.0) Median 7.4 (Min, Max) (3.4, 68.3) Height (cm) N = 50 Mean (Std ...

Primary Endpoint Composite Clinical Success1 40/43 (93.0%) Safety Endpoints 30-Day Serious Adverse Events 0.0% (0/50) 6-Month Serious Adverse Events 0.0% (0/50) 6-Month Device Events2 0.0% (0/50) Efficacy Endpoints Technical Success3 47/50 (94.0%) Procedure Success4 46/47 (97.9%) 6-Month Cl ...

d. Flush the device until air no longer exits the tip of the Delivery Catheter. e. When the initial flushing is completed, begin loading the Occluder by pushing the Slider up and then to the right until the Slider stops (Figure 4a). f. Complete Occluder loading by pushing the Slider down and then to t ...

left atrial septum. 6. Deploy the right atrial disc by pushing the Slider to the left until it stops and then down. Confirm that the Slider has moved completely to the left and down position (Figure 6c). Failure to move the Slider completely to the left and down position m ...