9-VSDMPIHDE-016
Abbott Amplatzer Post Infarct Muscular VSD Occluder 16mm x 24mm, 10mm
$1,499.00
box of 1
In Stock: 1 Each
Expiration:
Expired
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The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in-date item only.
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Description
Abbott SJM St. Jude Medical Amplatzer Post Infarct Muscular VSD Occluder
The Amplatzer™ P.I. Muscular VSD Occluder is intended for the closure of post myocardial infarction (P.I.) VSD. The 10 mm waist length is designed to accommodate the damaged muscular tissue of the septal wall following a myocardial infarction.
Product Code: 9-VSDMPIHDE-016
- Device Size/Waist Diameter: 16mm
- Disc Diameter: 26mm
- Waist Length: 10mm
- Device waist centers and closes the defect
- Symmetrical design allows a transcatheter femoral or arterial delivery approach
- Constructed from self-expanding Nitinol mesh and polyester material, which promotes tissue in-growth
- Precise placement through the device’s ability to be recaptured and redeployed
Indication for Use
The Amplatzer™ Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure (large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.
High-risk anatomical factors for transatrial or transarterial surgical closure include patients: Requiring left ventriculotomy or an extensive right ventriculotomy; With a failed previous VSD closure; With multiple apical and/or anterior muscular VSDs (“Swiss cheese septum”); With posterior apical VSDs covered by trabeculae.
Contraindications
The Amplatzer™ Muscular VSD Occluder is contraindicated for the following: Patients with defects less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid); Patients with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease; Patients with perimembranous (close to the aortic valve) VSD; Patients with post-infarction VSD; Patients who weigh less than 5.2 kg. (Patients smaller than 5.2 kg were studied in the clinical trial, but due to poor outcome, these patients have been contraindicated for device placement. Data from these patients has not been included in the overall analysis); Patients with sepsis (local/generalized); Patients with active bacterial infections; Patients with contraindications to antiplatelet therapy or agents.
Additional information
| Size | 16.00mm |
|---|---|
| Arms | N/A |
| Manufacturer | |
| Unit | box of 1 |
- FDA Product Code: MLV
- FDA Product Code Name: Transcatheter septal occluder
- GMDN Term Code: 45418
- GMDN Term Name: Cardiac defect occluder
- GMDN Term Description: An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.
