05430002070148

Organization name

FEops NV

SRN

BE-MF-000001008

Manufacturer status

Active

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• CW018

  FEops HEARTguide™ uses medical images and applies computational modelling and simulation to predict the device-anatomy interaction. The technology inevitably relies on assumptions and simplifications regarding anatomy, medical procedure and biomechanical interaction. As a result, model predictions may be inaccurate in certain cases. Redo-TAVI simulations are performed using a simplified cylindrical model and are not validated against postoperative data. Do not use the provided data for preprocedural planning if the anatomical region of interest changed significantly since the acquisition of the images. FEops HEARTguide™ simulates several options. Simulations can cover a mix of appropriate and suboptimal options. Appropriate alternatives may exist. The device apposition plot is derived from the 3D model of the simulation result. The device apposition plot is not intended to predict peri-device or paravalvular leaks and/or device migration. The contact area plot (TAVI) is also derived from the 3D model and is not intended to predict conduction abnormalities. FEops HEARTguide™ does not provide functionality to evaluate the access route (e.g. transfemoral).

Primary placement in Belgium; available across 21 countries total.

Trade name

not provided

UDI-DI code

05430002070148

Basic UDI-DI

5430002070FHG-SAEH

Reference / catalog number

05430002070148

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://chrome-extension//efaidnbmnnnibpcajpcglclefindmkaj/https://heartguide.s3.eu-central-1.amazonaws.com/static/DOC-118-FHG-IFU-v14.pdf

Clinical sizes

• Measurements described in IFU

• Z11039092VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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