#STEFAN KAISER ESSENTIA FREE#

#STEFAN KAISER ESSENTIA FREE#

Use echocardiography to ensure that the device does not impinge on the free atrial wall or aortic root.Prior to device detachment, evaluate the position of the device relative to the free atrial wall and the aortic root using echocardiography.Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.Some patients may also develop an allergy to nickel if this device is implanted. Certain allergic reactions can be serious patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. The Amplatzerв„ў Talismanв„ў PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe.Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath. Embolized devices must be removed as they may disrupt critical cardiac functions.This includes availability of a surgeon and access to operating room. Prepare for situations that require percutaneous or surgical removal of this device.The safety and effectiveness of the Amplatzerв„ў Talismanв„ў PFO Occluder has not been established in patients with a hypercoagulable state.Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO closure following standard of care.Do not use an open or damaged pouch do not use a damaged device.

Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.

Patients with active endocarditis or other untreated infections.

Patients with another source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.

Patients with anatomy in which the required Amplatzerв„ў Talismanв„ў PFO device size would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.

Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size.Patients with intra-cardiac thrombus, mass, vegetation, or tumor.Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained.The Amplatzerв„ў Talismanв„ў PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke. Important safety information INDICATIONS FOR USE

Stefan kaiser essentia