Inclusion Criteria:
* Aged between 18 and 65 years.
* Presence of a patent foramen ovale (PFO) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).
* Presence of a moderate-to-large right-to-left shunt (RLS) at rest or during the Valsalva maneuver, as confirmed by agitated saline contrast echocardiography (also known as bubble study).
* Clinically diagnosed with a PFO-associated ischemic stroke or transient ischemic attack (TIA).
Exclusion Criteria:
* An alternative, clearly identified cause of ischemic stroke or TIA (other than PFO) is determined by the investigator.
* Large territory cerebral infarction within 4 weeks prior to the planned procedure.
* Atherosclerotic stenosis (\>50%) of the carotid or vertebral arteries, as confirmed by CT angiography or vascular ultrasound per investigator assessment.
* Presence of intracardiac thrombus or vegetation as confirmed by echocardiography.
* Left ventricular ejection fraction (LVEF) \< 35%.
* Atrial fibrillation or atrial flutter.
* Left ventricular aneurysm or severe regional wall motion abnormality.
* Significant valvular stenosis or regurgitation, or history of valvular replacement or repair surgery.
* Pulmonary hypertension or a PFO constituting a special conduit (e.g., right-to-left shunt due to elevated right heart pressures).
* Other confirmed causes of right-to-left shunt, such as atrial septal defect (ASD) or pulmonary arteriovenous fistula.
* Complex PFO anatomy (e.g., multi-tunnel PFO) or PFO associated with an ASD requiring different closure strategy.
* Thrombus, mass, or vegetation identified at the intended implant site or along the potential delivery pathway.
* Acute myocardial infarction or unstable angina within 3 months prior to the procedure.
* Previous implantation of an inferior vena cava filter, PFO closure device, or ASD closure device.
* Any other condition deemed by the investigator to make the patient unsuitable for PFO device implantation.
* Concomitant cardiac anomalies requiring surgical correction.
* Uncontrolled systemic or local infection, or sepsis.
* Active infection requiring concurrent antibiotic therapy (Patients with transient conditions may be enrolled after completing antibiotic therapy and a subsequent 14-day washout period).
* Contraindication to antiplatelet or anticoagulant therapy (e.g., major bleeding within 3 months, known retinopathy, history of intracranial hemorrhage, or other significant intracranial pathology).
* Known hypersensitivity or allergy to tantalum or nickel.
* Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.
* Life expectancy less than 1 year due to malignancy or other comorbid disease.
* Current participation in another investigational drug or device clinical study that has not yet completed its primary endpoint.
