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Cardiac Valves

ALLEGRA™ Instruction for Use

The ALLEGRA™ TAVI System TF is a CE approved transcatheter heart valve system which is intended to treat degenerative calcified aortic valves or failing surgical aortic valve bioprostheses in a minimal invasive transcatheter implantation technique.

Download ALLEGRA™ Instruction for use

 

ALLEGRA™ Summary of Safety and Clinical Performance (SSCP) for user

Should you want to receive the SSCP of the ALLEGRA™ TAVI System TF, please use the request form below. This request will only be processed if you are a health care professional and clinical user of the device.

SSCP Request form for user:

The fields marked with * are mandatory.


11881-000-EN - Rev.04

CAUTION: Please note that the following pages are exclusively reserved for Health Care Professionals in countries with applicable health authority product registrations. To the extent this site contains information intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please contact your Biosensors International representative for availability or the products and registration status.

The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the "Instructions for Use" supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.

Biosensors’ interventional cardiology products, including BioMatrix NeoFlex™, BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, Chroma™, BioStream™, BMX-J®, BioPath™, Powerline™, RISE™ NC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT AG. Blue Sail Medical Co., Ltd is the parent company of NVT AG and Biosensors International Group, Ltd. and its affliates are collaborating for the commercialization of the ALLEGRA™ device.

BioMatrix NeoFlex, BioMatrix Alpha, BioFreedom, BioFreedom Ultra, Chroma, BioStream, BMX-J, BioPath, Juno, S-Stent, Powerline, Rise NC and Quadrature Link are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. ALLEGRA™ is CE Mark approved (CE 0124). All other cited trademarks are the property of their respective owners.