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STRUCTURAL INTERVENTIONS

AMPLATZER™ TALISMAN™
PFO OCCLUDER CLINICAL DATA

Effective PFO closure is made easier with the Amplatzer™ Talisman™ PFO Occluder.5 For patients who have experienced a PFO-associated stroke, clinical trials have shown that they can benefit from PFO closure.1-3 This minimally-invasive procedure significantly reduces the risk of recurrent ischemic stroke and offers an excellent safety profile.

THE LANDMARK RESPECT TRIAL1

Still the definitive clinical trial on PFO closure

Study design

The RESPECT trial is the largest trial ever conducted on PFO closure. This trial studied the Amplatzer™ PFO Occluder, on which the new Amplatzer™ Talisman™ device is based.

It stands apart from other PFO closure studies since it's the largest clinical trial with the most extensive follow-up, spanning 13 years. The 980 enrolled patients were followed for a median of 5.9 years. Researchers ultimately collected 5,810 patient-years of data—almost 2 times more than other PFO trials.

The trial was conducted at 69 centers across the U.S. and Canada and included patients on anticoagulation therapy – a real-world cross-section of patients – unlike other PFO trials, REDUCE2 and CLOSE3.
 

The findings

The RESPECT trial offers conclusive evidence that using the Amplatzer PFO Occluder to close the PFO in patients with a PFO-associated stroke is more beneficial than medical therapy alone, in reducing the risk of another stroke.

A meta-analysis on three randomized controlled trials on PFO

A meta-analysis on three randomized controlled trials on PFO closure confirmed that..."PFO closure was superior to medical therapy for secondary prevention of stroke…with a more robust benefit when the Amplatzer™ PFO Occluder...was used.”4

Summary of findings

Excellent procedural results 

The RESPECT trial data revealed high rates of technical and procedural success, and excellent closure.1 At only 6 months, most patients also demonstrated freedom from shunt — both at rest and during Valsalva.1

99.1%

TECHNICAL SUCCESS*

96.1%

PROCEDURAL SUCCESS†

94.2%

EFFECTIVE CLOSURE
(N ≤ 9 BUBBLES)

Excellent safety1

0%

DEVICE EMBOLIZATION

0%

DEVICE EROSION

0%

DEVICE THROMBUS

Note: Rates are calculated based on data in final publication.
*Successful delivery and release of the device at the time of first procedure for subjects in whom a study device was attempted.
†Successful implant at the time of the first procedure with no reported in-hospital serious adverse events.

  • Significantly lower risk of recurrent stroke

    The RESPECT trial revealed a 62% relative risk reduction for recurrent cryptogenic ischemic stroke with the Amplatzer™ PFO Occluder vs medical therapy.1
     

    The trial showed there was a 45% relative risk reduction for any recurrent ischemic stroke over nearly 6 years of follow-up, compared to medical therapy.1
     

  • Low rates of atrial fibrillation

    The RESPECT trial also revealed low rates of serious atrial fibrillation (AF) with the Amplatzer™ device, consistent with medical therapy.1

MAT-2500547 v1.0 | Item approved for U.S. use only.

References
  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;377:1022-1032. doi: 10.1056/NEJMoa1610057.
  2. Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377:1033-1042. doi: 10.1056/NEJMoa1707404.
  3. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011-1021 and supplementary appendix. doi: 10.1056/NEJMoa1705915.
  4. Mojadidi MK, Zaman MO, Elgendy IY, et al. Cryptogenic stroke and patent foramen ovale. J Am Coll Cardiol. 2018;71(9):1035-1043. doi: 10.1016/j.jacc.2017.12.059.
  5. Tests performed by and data on file at Abbott.
  6. Amplatzer™ Talisman™ PFO Occluder Instructions For Use.
Important Safety Information

Rx Only

AMPLATZER™ TALISMAN™ PFO OCCLUDER

INDICATION 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

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; Patients with intra-cardiac thrombus, mass, vegetation, or tumor; Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size; Patients with anatomy in which the required Amplatzer™ Talisman™ PFO device size would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins; Patients with another source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum; Patients with active endocarditis or other untreated infections; Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.

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; Headache/migraine; Hematoma; Hypertension/hypotension; 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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