PRODUCT DESCRIPTION
TAVIPILOT is an intra-operative software tool which provides real-time image guidance in addition to conventional fluoroscopy guidance for TAVI/TAVR procedures.
TAVIPILOT offers:
- detection, tracking and marking of the non-coronary cusp (NCC)
- detection, tracking and marking of the Virtual Lucent Line (VLL) on the Transcatheter Aortic
- Valve (TAV) distance between NCC and the bottom of the TAV (as a percentage of the current TAV’s height)
Clinical benefits
TAVIPILOT provides accurate detection, tracking and marking of the NCC and TAV, allowing the user to clearly visualize the relevant anatomy and have guidance during the TAVI procedure. The clinician therefore benefits from an enhanced visualization of anatomical and TAVI/TAVR implant landmarks and guidance during the procedure, improving patient management.
Performance Characteristics
Detection and tracking accuracy:
Non-coronary cusp:
+/- 1 mm accuracy in 93% of all tested patients*
+/- 2 mm accuracy in 100% of all tested patients*
Prosthetic valve:
+/- 1 mm accuracy in 100% of all tested patients*
*Based on per patient median
INTENDED USE
Indications for Use
TAVIPILOT is an intra-operative software which provides real-time fluoroscopy detection, tracking and marking of the Non-Coronary Cusp and the prosthetic valve, to allow optimal guidance for precise positioning of the prosthetic valve, according to the planning phase, for TAVI/TAVR (transcatheter aortic valve implantation/replacement) procedures. The guidance provided by TAVIPILOT is not intended to substitute the cardiac surgeon’s or the interventional cardiologist’s judgment and analysis of the patient’s condition.
The device is only suitable for adults (i.e., 21 years and older).
Contra-indications:
- Patients who have already undergone a TAVI/TAVR or SAVR (surgical aortic valve replacement)
- Patients diagnosed with aortic insufficiency
- Patients for whom the main access for the TAVI/TAVR catheter is not femoral
- Patients who have a non-tricuspid native valve
- Patients who have a permanent Pacemaker implant or temporary Pacemaker within 2 cm from the aortic root, other than the pacing guidewire
- Patients who have thoracic surgical implants
- Patients who are not adults
Intended Patient Population
TAVIPILOT is suitable for patients with structural heart diseases who are considered appropriate candidates for treatment with a TAVI/TAVR procedure.
The device is only suitable for adults (i.e., 21 years and older).
Intended Users
The user is a clinical specialist who is fully skilled and qualified to perform the TAVI/TAVR procedure and is responsible for sound clinical judgement and for applying the best clinical procedure, such as a cardiac/cardiothoracic surgeon or interventional cardiologist.
Before using TAVIPILOT, users must complete the required training in the safe, intended, and effective use of the device and demonstrate their ability to operate it correctly. Only after receiving certification may a user operate TAVIPILOT. Uncertified users should not have access to the device.
Intended Use Environment
TAVIPILOT is intended to be used in the control room and in the examination room of an interventional suite and/or a hybrid operating room. TAVIPILOT integrates in the existing operating room environment, usually containing an examination room (where the patient is), and a control room. The system is connected to an interventional (C-arm) X-ray system.
CARANX CONTACT INFORMATION
Contact details
Postal address: Caranx Medical, 400 Promenade des Anglais, 06200 Nice, France
Web address: www.carvolix.eu
Email: sales@carvolix.eu
WARNINGS, CAUTIONS AND NOTICES
WARNINGS
- TAVIPILOT can only to be used by authorized and qualified
In TAVIPILOT’s context, authorized means those that are cardiac/cardiothoracic surgeons or interventional cardiologists and qualified means those trained and skilled to perform TAVI/TAVR procedures.
Caranx is not responsible for any complications resulting from the use of TAVIPILOT by unauthorized and unqualified personnel.
- The guidance provided by TAVIPILOT is not intended to substitute the user’s judgment and analysis of the patient’s condition.
- TAVIPILOT must be used in conjunction with other methods of assessing clinical signs and symptoms.
- No modification of TAVIPILOT is allowed.
- Before using TAVIPILOT, users must be trained and competent in:
- operating TAVIPILOT,
- in using the TAV delivery device, including guidewires and accessories,
- in using the X-ray C-arm device and any related accessories.
- TAVIPILOT can only be used with the following valve types manufactured by Edwards Lifesciences:
- Edwards SAPIEN 3 Ultra RESILIA (with sizes 20 mm, 23 mm, 26 mm, 29 mm)
- Edwards SAPIEN 3 Ultra (with sizes 20 mm, 23 mm, 26 mm)
- Edwards SAPIEN 3 (with sizes 20 mm, 23 mm, 26 mm, 29 mm)
- TAVIPILOT can mark a virtual lucent line (VLL) on the TAV between 0% to 50% of the current TAV’s height (where 0% is the bottom of the TAV and 50% is the middle of the TAV). The VLL is a geometric reference line illustrating a specific percentage of the current TAV’s height.
- The VLL does not indicate the implantation depth or the final landing position of the TAV once it is fully expanded.
- The TAV may shift during deployment and the VLL does not compensate for this movement.
- Selecting a wrong valve type, a wrong valve size or a wrong VLL location for the patient may lead to a compromised detection and tracking of the valve implant by TAVIPILOT, which may lead to an inaccurate positioning of the valve implant.
- TAVIPILOT can be used with approved X-ray C-arm devices with the following configurations:
- Field of View (FOV) between 160x160mm and 300x300mm
- C-arm acquisition frame rates of 5 to 30 frames per second
- Minimum image resolution 512 pixels by 512 pixels, 1:1 aspect ratio
Failure to meet one of these configurations may lead to an inaccurate positioning of the valve implant due to inaccurate AI output.
- The positioning of the X-ray C-arm needs to meet the following requirements:
- using only 3-cusp coplanar view: any C-arm angulation allowing for visualization of the three cusps (non-coronary, right, left) in the same plane, or
- 2-cusp overlap view: any C-arm angulation allowing for visualization of the isolated noncoronary cusp and overlapped right- and left-coronary, and
- avoiding any parallax effect on the TAV.
Failure to meet one of these requirements may lead to an inaccurate positioning of the valve implant due to inaccurate AI output.
- TAVIPILOT can be used with the following cleared pigtail catheters:
- Cordis 534-550S INFINITI ® Diagnostic Catheters Ventricular Pigtail 5F/6F 110 cm
- Cordis SR2278 SuperTorque ® Plus Angled Pigtail 5.2F 125 cm
- Boston Scientific Impulse 5F 125cm
- Cordis 533-650F SUPER TORQUE Diagnostic Catheters 6F 110 cm
- The pigtail catheter must be placed in the non-coronary cusp (NCC) to ensure a more precise detection of the NCC and the VLL location.
- Only one pigtail catheter should be used when using TAVIPILOT.
- TAVIPILOT’s Live Tracking Confidence must not replace the user’s best judgement and reasonable caution. Even a very high confidence does not ensure absolute certainty, nor a moderate confidence level does not necessarily mean that the target is incorrect.
- A new patient procedure must not be started until the previous guided procedure has been properly finalized in TAVIPILOT. Failure to finalize the prior procedure may result in incorrect settings being used for the new patient. (See Section 5.7 End Live Tasks)
- All warnings, cautions, notices and contraindications that apply for other devices including valve implants, X-ray C-arms, pigtails and contrast agent devices, as described in the Instructions for Use for said devices and their supporting devices, also apply for procedures where TAVIPILOT is used.
