Over 20 years ago, we pioneered PFO closure with the Amplatzer™ PFO Occluder. Today, it is the most-studied — and most-trusted — device of its kind, with over 180,000 patients treated worldwide.2
And our clinical evidence is unmatched, thanks to the largest-ever trial for PFO closure, boasting 5,810 patient-years of data.3
With the introduction of the Amplatzer™ Talisman™ PFO Occluder, we have built upon the proven Amplatzer PFO closure technology. We've added the 30mm size so you have the complete PFO portfolio for every case. And the occluder now comes assembled and ready to use, simplifying prep and enhancing ease-of-use.
The easy-to-use just got easier.
The Amplatzer™ App helps physicians choose the right Amplatzer™ device to meet the needs of each case.
Sizing and Device Selection | |||
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Amplatzer™ Talisman™ PFO Occluder | |||
Model/Reorder Number | Right Atrial Disc Diameter A | Left Atrial Disc Diameter B | Recommended Sheath Size |
9-PFO-1818 | 18 mm | 18 mm | 8 F; 45° curve |
9-PFO-2518 | 25 mm | 18 mm | 8 F; 45° curve |
9-PFO-3025 | 30 mm | 25 mm | 9 F; 45° curve |
9-PFO-3525 | 35 mm | 25 mm | 9 F; 45° curve |
Delivery Sheath | |||||
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Amplatzer™ Talisman™ Delivery Sheath | |||||
Model/Reorder Number | Sheath Size | Tip Angle | Sheath Inner Diameter | Sheath Outer Diameter | Usable Length |
9-TDS-08F45-80 | 8 F | 45° | 2.69 mm | 3.45 mm | 80 cm |
9-TDS-09F45-80 | 9 F | 45° | 3.00 mm | 3.81 mm | 80 cm |
Ancillary Products | ||||
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Amplatzer™ Guidewire | ||||
Model/Reorder Number | Diameter | Body | Tip Description | Usable Length |
9-GW-002 | 0.035 inch | Super Stiff | 1.55 mm, Modified J-tip | 260 cm |
Device Sizing Guidelines | ||
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PFO Morphology | Example Anatomical Characteristics | Suggested Amplatzer™ Talisman™ PFO Occluder size (mm) |
Simple PFO or PFO with a non-prominent ASA PFO where a secure device position and effective PFO closure can be achieved when using the 25 mm device size |
| 25 |
Complex PFO PFO with one or more anatomical characteristics that may complicate the ability to achieve a secure device position and effective PFO closure when using the 25 mm device size |
| 30 or 35 |
PFO with small anatomy Anatomy not suitable for 25 mm device size secondary to interference with adjacent cardiac structures |
| 18 |
Note: Evaluate the position of the device after deployment, but before detachment. Use echocardiography to ensure that the device does not impinge on the free atrial wall or aortic root. If the device interferes with an adjacent cardiac structure (such as free atrial wall or aortic root), recapture the device and redeploy. If device position remains unsatisfactory, recapture the device and either replace with a smaller device (18 mm or 25 mm) or refer the patient for alternative treatment. The presence of an ASA alone does not necessarily prevent successful PFO closure with a 25 mm device size. In RESPECT1, 180 patients (36%) in the device closure group had an ASA. The 25 mm device size was used in the majority of patients with an ASA (77%) to close the PFO, and at 6-months post-implant, effective closure was achieved in 95% of these patients. There were no cases of device embolization in any patient in the study 1. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-32. |
Indications for Use
The Amplatzer™ Talisman™ 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.
Contraindications
Warnings
Precautions for Special Populations
Precuations
CAUTION: Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) is recommended as an aid in evaluating the PFO and placing the Amplatzer™ Talisman™ PFO Occluder. If TEE is used, the patient’s esophageal anatomy must be adequate for placement.
CAUTION: Be cautious when using fluoroscopic X-ray guidance, which may be used during placement of the device.
CAUTION: Do not use a power injection system to put contrast solution through the sheath.
Patient Counseling Information
Physicians should review the following information when counseling patients about the Amplatzer™ Talisman™ PFO Occluder and the implant procedure:
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.
Potential Adverse Events
Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to:
Indications for Use
The Amplatzer™ Talisman™ Delivery Sheath is indicated to provide a pathway through which an Amplatzer™ PFO Occluder is introduced for patent foramen ovale closure.
Contraindications
Warnings
Precautions
Potential Adverse Events
Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to:
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