Effective PFO closure is made easier with the Amplatzer™ Talisman™ PFO Occluder.1 For patients who have experienced a PFO-associated stroke, clinical trials have shown that they can benefit from PFO closure.2-4 This minimally-invasive procedure significantly reduces the risk of recurrent ischemic stroke and offers an excellent safety profile.
IN PFO CLOSURE1
As the device that created the category, the Amplatzer™ PFO Occluder has sustained leadership over decades of use by pursuing clinical evidence to become the first device supported by positive PFO trial results.2
Today, it is the most-studied device of its kind, with over 180,000 patients treated worldwide.1 And our clinical evidence is unmatched, thanks to the largest-ever trial for PFO closure, boasting 5,810 patient-years of data.2
About the Amplatzer™ Talisman™
With the Amplatzer™ Talisman™ PFO Occluder, the device you know and trust just got better. It is built on the proven Amplatzer PFO closure technology and the Amplatzer Trevisio™ Delivery System, with key enhancements to make it our most advanced and easy-to-use PFO closure device yet:
- We've added a 30 mm device so you have the complete PFO portfolio for every case
- The occluder comes assembled and ready to use, simplifying preparation and enhancing ease-of-use
The PFO Occluder trusted by thousands of physicians around the world1
WE SET THE STANDARD
- Pioneered treatment with a PFO-specific device
- Available in over 80 countries around the world
PATIENT-YEARS OF DATA2
WE RAISE THE BAR
- With the landmark RESPECT trial,2 we had the most extensive patient follow-up, almost 2x more than other PFO trials
- RESPECT was also the only trial to include patients on anticoagulation therapy, a real-world cross-section of patients
PATIENTS IMPLANTED WITH DEVICE IN RCTS2-4
WE DEMONSTRATE EXCELLENCE
- ZERO device erosions, thrombus, or embolization events in 6 published trials with 990 patients
- 94.2% effective closure rate at 6 months
How to implant the Amplatzer Talisman
Watch the Amplatzer™ Talisman™ PFO Occluder implant procedure video.
PATIENTS WHO BENEFIT
FROM PFO CLOSURE
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.
Among patients with a PFO who have had an ischemic stroke, the Amplatzer Talisman PFO Occluder has demonstrated excellent safety and effectiveness in reducing the risk of recurrent stroke.
59% RELATIVE RISK REDUCTION IN RECURRENT ISCHEMIC STROKE5
LESS ANXIETY, MORE PEACE-OF-MIND
For patients who have experienced a PFO-associated stroke, the thought of a recurrence can generate anxiety. Determining and delivering the most effective treatment soon after a stroke is critically important to provide these patients with peace-of-mind.
For patients and caregivers wanting to learn more about PFO-associated stroke and PFO closure, www.PFOstroke.com is an excellent resource, including:
- All about PFO and stroke
- Understanding PFO treatment options
- Information about the Amplatzer Talisman PFO Occluder
- Resources, including FAQ and brochures
One week after her PFO closure, Christine was back on the treadmill running 5 miles an hour - (Christine Lee - USA)
After Christine Lee’s stroke at age 33, her neurologist ordered a transesophageal echocardiogram to look for a PFO. Nearly 6 months after her first stroke, she had a TIA. Her neurologist then made a referral to an interventional cardiologist, and he recommended she get the PFO closure procedure within 7 days.
Hear about her experience
“I’ve had so many emails from readers who say their neurologist won’t make that referral to an interventional cardiologist. They just won’t. They want to know the name of my cardiologist, because they’re so desperate.”
Advancing the Gold Standard in PFO Closure
For decades, interventional cardiologists have trusted the Amplatzer™ PFO Occluder for ease-of-use, safety, and excellent clinical outcomes.2 With our latest addition, the Amplatzer™ Talisman™ PFO Occlusion System, the easy-to-use just got easier:
- We've added a 30mm device so you have the complete PFO portfolio for every case.
- The occluder comes assembled and ready to use, streamlining preparation and enhancing the user experience.
Unique design features set the Amplatzer Talisman PFO Occluder apart from the rest.
*Only the 18 mm size is not asymmetric.
Minimizing Complexity in PFO Closure
Occluder comes assembled to Trevisio™ delivery cable, ready to use
RECAPTURABLE AND REPOSITIONABLE
Self-expanding discs align to the PFO without an additional “locking” step and can be adjusted for ideal placement
8 F and 9 F introducer sheaths enable treatment of patients with smaller vasculature
NEW VERSION AVAILABLE
GET THE AMPLATZER PORTFOLIO APP
The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
MAT-2008367 v5.0 | Item approved for U.S. use only.