False Lumen Embolization System
The False Lumen Embolization System
Caution – INVESTIGATIONAL DEVICE, LIMITED TO INVESTIGATIONAL USE ONLY. This product is not commercially available.
Intended Use: The False Lumen Embolization System is indicated for use in patients with subacute or chronic aortic dissection. After or during the primary entry tear repair procedure, the False Lumen Embolization System is intended to obstruct or reduce the rate of blood flow in the false lumen.
The False Lumen Embolization System is intended for use by physicians trained and experienced in endovascular management of aortic dissection, embolization techniques, angiographic techniques, and interventional procedures. Standard techniques for placement of vascular access sheaths, introducer sheaths, and guidewires should be employed.
MRI & Safety Information
MR CONDITIONAL
Non-clinical testing and MRI simulations were performed to evaluate the Implant in its worst-case (largest) configuration. Non-clinical testing demonstrated that the Implant is MR Conditional. A patient implanted with one or more Implants may be scanned safely in an MR system under the following conditions:
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- Static, horizontal, magnetic field of 1.5-Tesla or 3-Tesla, only
- Maximum spatial gradient magnetic field of 10,000-gauss/cm (100-T/m)
- Maximum whole body averaged (WBA) specific absorption rate (SAR) in Normal Operating Mode
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- 1.5-Tesla/64-MHz, WBA SAR, 1-W/kg
- 3-Tesla/128MHz, WBA SAR, 2-W/kg
- Scan Duration and Wait Time
- 1.5-Tesla/64-MHz, WBA SAR, 1-W/kg: 10 minutes continuous RF exposure, followed by 20 minute wait period, repeated twice in 60 minutes. Alternatively, the patient may undergo 15 minutes continuous RF exposure, followed by a 45 minute wait period (once per 60 minutes).
- 3-Tesla/128-MHz, WBA SAR, 2-W/kg: 60 minutes continuous RF exposure (i.e., per pulse sequence or back-to-back sequences/series without breaks).
Under the scan conditions defined, the Implant is expected to produce a temperature rise of less than or equal to 6°C.
In non-clinical testing, the image artifact caused by the Implant extends approximately 4 mm from the device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.