Important Safety Information
The CARLEN System is investigational and not available for commercial use in any geography.
CAUTION: Investigational device. Limited by Federal (or the United States) Law to investigational use.
Exclusively for clinical investigation.
MRI Safety Information
The Cardiac Leaflet Enhancer (CARLEN) Implant is MR Conditional. A patient with the Cardiac Leaflet Enhancer (CARLEN) Implant may be safely scanned under the following conditions. Failure to follow those conditions may result in injury to the patient.
| Parameter | Condition of Use/Information |
|---|---|
| Nominal Values of Static Magnetic Field (T) | 1.5-Tesla or 3.0-Tesla |
| Maximum Spatial Field Gradient (T/m and gauss/cm) | 40-T/m (4,000-gauss/cm) |
| Type of RF Excitation | Circularly Polarized (CP) (i.e., Quadrature-Transmission) |
| Transmit RF Coil | Any transmit RF coil may be used |
| Receive RF Coil | Any receive-only RF coil may be used |
| Maximum Whole Body Averaged SAR (W/kg) | 2-W/kg (Normal Operating Mode) |
| Limits on Scan Duration | Whole body averaged SAR of 2-W/kg for 60 minutes of continuous RF exposure (i.e., per pulse sequence or back-to-back sequences/series without breaks) |
| MRI Image Artifact | The presence of this implant produces an imaging artifact. Therefore, carefully select the pulse sequence parameters if the implant is located in the area of interest. |
The CARLEN System Important Safety Information
Intended Use
The CARLEN System is indicated for the treatment of symptomatic, moderate-severe or severe functional (or secondary) mitral valve regurgitation (MR ≥ 3+) in whom the local Heart Team has determined that transcatheter repair is suitable.
Contraindications
The CARLEN System is contraindicated in patients with the following conditions:
- Patients who cannot tolerate procedural anticoagulation or post-procedural anti-platelet regimen
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous thrombus
- Active endocarditis of the mitral valve
- Untreatable hypersensitivity or contraindication to nitinol alloys (nickel and titanium) or contrast media
Warnings & Cautions
- The CARLEN System should be handled and used in a sterile environment, in a facility with a cardiac catheterization laboratory equipped with fluoroscopy and 2D and 3D transesophageal echocardiography. The facility must have on-site cardiac surgery with immediate access to a cardiac operating room and a team.
- Use of the CARLEN System should be restricted to those physicians trained to perform invasive interventional structural heart procedures and those trained in the proper use of the CARLEN System.
- The CARLEN System is designed for single use only. Cleaning, re-sterilization, and/or reuse may result in infections, malfunction of the device, other serious injuries, or death.
- DO NOT use the CARLEN System after the “Use by” date stated on the package label.
- Always inspect the CARLEN System and its packaging to verify that damage has not occurred because of shipping and handling and that the sterile barrier has not been compromised. DO NOT use the device if damage is detected.
- All catheter manipulations should be done with care. DO NOT continue to rotate or manipulate any of the handle controls if significant resistance is noted. Device damage may occur.
Anatomical Considerations
For optimal results, the following anatomic characteristics should be considered when using the CARLEN System. While the safety and effectiveness of the system have not been studied in the following conditions, use in the presence of these conditions may interfere with placement of the CARLEN Implant:
- Moderate or severe calcification or vegetations at the site of the target leaflet grasping region
- Severe calcification in the annular or sub-valvular apparatus extending into the leaflets and impacting leaflet mobility
- Significant clefts or perforations in the mitral leaflet
- Leaflet length < 7 mm
