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• Antibiotics should be administered peri-procedurally.
• Patients should be fully heparinized throughout the procedure using adequate dosing so as to keep the activated clotting
time (ACT) greater than 200 seconds.
Patient Counseling Information
Physicians should review the following information when counseling patients about the Amplatzer™ Talisman™ PFO Occluder
and the implant procedure:
• PFO closure with the Amplatzer™ Talisman™ PFO Occluder can only reduce the risk for a recurrent stroke due to a
paradoxical embolism through a PFO.
- With aging there is an increased likelihood that non-PFO related risks for stroke may develop and cause a recurrent
ischemic stroke independent of PFO closure.
• For procedural risks associated with the Amplatzer™ Talisman™ PFO Occluder, refer to Potential Adverse Events.
• The need for adherence to a defined adjunctive antithrombotic therapy following implantation of the Amplatzer™ Talisman™
PFO Occluder.
• Patients with a history of DVT or PE may benefit from continuation or resumption of anticoagulation therapy following
implantation of the Amplatzer™ Talisman™ PFO Occluder to reduce the risk of recurrent DVT or PE.
It is recommended that the medical team (neurologist and cardiologist) and the patient engage in a shared decision-making
process and discuss the risks and benefits of PFO closure in comparison to using antithrombotic therapy alone, while taking
into account the patient's values and preferences.
MR Conditional
Non-clinical testing has demonstrated that the Amplatzer™ Talisman™ PFO Occluder is MR Conditional. A patient with the
Amplatzer™ Talisman™ PFO Occluder can be safely scanned in an MR system under the following conditions:
• Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T)
• Maximum spatial gradient field of 19 T/m (1900 G/cm)
• Maximum MR system-reported whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating
mode)
Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or
equal to 3ºC after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 16 mm from the
Amplatzer™ Talisman™ PFO Occluder when imaged with a gradient echo pulse sequence in a 3.0T MR system.
Potential Adverse Events
Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to:
•
Air embolus
•
Allergic reaction/toxic effect due to: •
anesthesia, contrast media,
medication, or metal
•
Arrhythmia
•
Arteriovenous fistulae
•
Bleeding
•
Cardiac perforation
•
Cardiac tamponade
•
Chest pain
•
Death
•
Deep vein thrombosis
•
Device embolization
•
Device erosion
•
Endocarditis
•
Esophagus injury
•
Fever
•
Hematoma
•
Hypertension/hypotension
Intended Clinical Benefits
The intended clinical benefit of the pre-attached Amplatzer™ Talisman™ PFO Occluder include:
• A clinically significant reduction in the risk of ischemic stroke as compared to medical therapy alone as demonstrated in
the RESPECT trial
, where a 45% reduction in the relative risk of recurrent ischemic stroke was observed when
1
compared to medical management (P = 0.046),
•
Infection
Myocardial infarction
•
Pacemaker placement
secondary to PFO device closure
•
Pain
•
Pericardial effusion
•
Pericarditis
•
Peripheral embolism
•
Pseudoaneurysm
•
Pulmonary embolism
•
Reintervention for residual
shunt/device removal
•
Stroke
•
Transient ischemic attack
•
Thrombus formation
•
Valvular regurgitation
•
Vascular access site injury
•
Vessel perforation
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