FVSO Devices are the standard of care for minimally invasive atrial septal defect (ASD) closure. These double-disc occluders are comprised of nitinol mesh and ePTFE material. They are designed to securely appose the septal wall on each side of the defect and create a platform for tissue in-growth after implantation. The device has a fenestration to create an obligatory shunt when there is raised RA or LA pressure to prevent diastolic dysfunction or impaired cardiac output.

Different size FVSO devices are made to close different sizes of ASD

Variety Does NOT Matter

Atrial septal defects come in a variety of shapes and sizes. They can often be multiple, or fenestrated, mal-aligned or spiral ASDs with variation in special orientation. Biological offers a unique model of Versatile percutaneous, transcatheter occluders that can close any morphologic variation of all these different types of atrial septal defects while maintaining a small predetermind atrial communication as a popoff.

FVSO Device

The FVSO device is made of Nitinol similar to currently many devices used for ASD closure . The similarity ends there as there are numerous differentiating aspects to the advantage of VSO. It versatile as the name suggests. It can be deployed to a large range of sizes of defects with a single device without the need for balloon sizing to precise measurements. This is attributed to graded sizes of the middle segment which has 3 grooves: one closer to the LA disc which has the largest diameter and the other closer to the RA disc has the smallest diameter. The central grove has the intermediary diameter making it suitable for 5 mm range. Thus 6 devices cover the full range of ASDs between 12 mm 36 mm beyond the range will also be available on request. The extra middle segment (Please see Fig 1 for details) gives more length to the device with a smaller deployed profile (3 mm) making the device deployment much easier and less cumbersome.  The equal size of the right atrial and left atrial disc provides better stability and reduces the risk of embolization. The softer material profile potentially reduces the risk of erosion associated with the other devices. The LA disc is smoother with no protrusion minimizing the risk of thrombus formation.  Due to the ease of deployment, suitability to close a range of defects with a single device and stability of the device makes it potentially suitable for deployment without angiographic support making closure with minimal or zero radiation.

The device formed in a predetermined shape can be collapsed and inserted into the lumen of a delivery catheter. The device is advanced through the catheter and out the distal end, whereupon, due to its memory property it will tend to substantially returns to its expanded state adjacent the treatment site. In accordance with a first of these embodiments, a generally elongate medical device has a generally tubular middle portion and a pair of expanded diameter portions, with one expanded diameter portion positioned at either end of the middle portion. The middle segment and two ends are further covered with a fabric to prevent blood flow through the device.

Designed for Optimal ASD Occlusion with a predetermined Fenestration

Fig 1 onface and Side view of the FVSO device: The right image is the onface view of the FVSO from the RA side. Left: The middle segment with 3 different size groves fit to the morphologically variable defects of different ranges and fills the defect.

Ordering Information

VSO Device

Indications for Use
The Fenestrated Versatile Atrial Septal Occluder Device is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require reduction of the fenestration. Patients indicated for FVSO device should have echocardiographic or hemodynamic evidence of ostium secundum atrial septal defect and clinical evidence of ventricular volume overload (raised EDP) and mean Pulmonary Artery pressure above 18mm Hg.

Contraindications

The FVSO Device is contraindicated for the following:

• Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
• Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months.
• Any patient known to have a demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
• Any patient whose size does not allow the passage of the delivery system or the procedure would cause hemodynamic instability.
• Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

Warnings

• Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
• Embolized devices must be removed as they may disrupt critical cardiac functions. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath.
• Use on or before the expiration date noted on the product packaging.
• This device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
• Do not use the device if the packaging sterile barrier is open or damaged.
• Do not release the VSO Device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). Recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
• The use of echocardiographic imaging (TTE, TEE, or ICE) is required.
• Patients with a retro-aortic rim of less than 5 mm in any echocardiographic plane, or patients in whom the device physically impinges on (i.e. indents or distorts) the aortic root, may be at the potential risk of erosion.
• Select only devices within the recommended range for the device.

Precautions

• Use standard interventional cardiac catheterization techniques to place this device.
• Placement of the FVSO Device may impact future cardiac interventions, for example transeptal puncture and mitral valve repair.
• This device contains nickel-titanium alloy, which is generally considered safe. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.

Handling
Store in a dry place.

Procedural

• This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using this device.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
• Aspirin (for example, 81 mg) or an alternative antiplatelet/anticoagulant is recommended for 3 months after the device deployment. Antibiotic prophylaxis is recommended to cover the procedure.
• Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
• If TEE is used, the patient's esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

Post-implant

• Patients should take appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
• Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 3 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 3 months is at the discretion of the physician.
• Clinical follow-up with a cardiologist and echocardiograms are recommended at implant, 1 day post-implant, and again at 6 week, 6 months, and 12 months post-implant. Immediate follow-up with a cardiologist with the onset of any new symptoms suggestive of erosion or impending erosion, and routine clinical follow-up annually thereafter is also recommended.

Use in Specific Populations

• Pregnancy – It is safe to do the implantation of VSO device provided no or minimal radiation exposure to the fetus and the mother.
• Nursing mothers - There has been no quantitative assessment of the presence of leachables from the device/procedure in breast milk, and the risk to nursing mothers is unknown.

MR Conditional to 3.0 Tesla
Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla. Through non-clinical testing, VSO device has been known to be MR Conditional at field strengths of 3.0 tesla or less.  The VSO device should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

Potential Adverse Events
Potential adverse events may occur during or after a procedure placing this device may include, but are not limited to:

• Air embolus
• Allergic dye reaction
• Anesthesia reactions
• Apnea
• Arrhythmia
• Cardiac tamponade
• Death
• Embolization
• Fever
• Hypertension/hypotension
• Infection including endocarditis
• Need for surgery
• Pericardial effusion
• Perforation of vessel or myocardium
• Pseudoaneurysm including blood loss requiring transfusion
• Tissue erosion
• Thrombus formation on discs
• Stroke
• Valvular regurgitation