JenaValve Technology, Inc.

Warnings General: The Trilogy® THV is only to be used with the Trilogy® INT, Trilogy® DC and Trilogy® LT. Use of other devices may damage the THV and/or result in patient injury. This procedure should only be performed by physicians experienced in transcatheter aortic valve replacement (TAVR) procedures and trained in the use of the Trilogy® Transcatheter Heart Valve System, and where emergency cardiac surgery (surgical aortic valve replacement) may be promptly performed. Only physicians who have successfully completed the JenaValve Professional Education training program are authorized to use the Trilogy Heart Valve System. The procedure must be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. Ensure the guidewire is in proper location in the ventricle throughout the procedure to mitigate risk of ventricular wall perforation. Improper management of the guidewire, allowing it to move forward into the left ventricle, may lead to ventricular injury requiring intervention. Systemic anticoagulation with heparin should be administered and adjusted as needed throughout the procedure per hospital and physician preference. Activated clotting time (ACT) > 250 seconds is recommended to be maintained prior to Introducer Sheath insertion through completion of the procedure. Failure to maintain proper ACT levels may lead to patient harm or death. If heparin is contraindicated, an alternative anticoagulant should be considered and administered as per institutional policy. The THV must be sized appropriately to fit the patient’s anatomy. Proper device sizing is the responsibility of the treating physician. Refer to the THV sizing chart in the instructions for use. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed under the potential adverse events section. DO NOT bend or kink the Introducer Sheath. Doing so may damage the Delivery Catheter and the THV during or after the loading process. DO NOT mix the sizes of the THV, Delivery Catheter, or Loading Tools. Use of mixed size configurations of THV, Delivery Catheter, and Loading Tools may result in implantation difficulties such as premature/failure to release the THV from the Delivery Catheter, THV damage, or patient injury requiring intervention. DO NOT use the Trilogy® THV System components if: the Use-By date has elapsed; the packaging or any of its components are not sterile or have been unintentionally opened before use; or the product has been dropped, damaged, or mishandled. DO NOT use the Trilogy® INT with any pre-implant balloon valvuloplasty catheter. Trilogy THV: DO NOT use the THV if: the serial number tag is missing or does not match the container label; the container or seal is damaged, cracked, or leaking; the temperature indicator is out of range; or the THV is not fully covered in solution after opening the package. Incorrect sizing of the THV with the patient’s native aortic valve may lead to paravalvular leak, migration, annular injury, embolization, and/or unsuccessful implant. Accelerated deterioration of the THV may occur in patients with an altered calcium metabolism.

From the manufacturer's own website. Source

JenaValve Technology, Inc. manufactures components for transcatheter aortic valve replacement (TAVR), including the Trilogy Introducer Sheath/Dilator, Trilogy Delivery Catheter, Trilogy Loading Tools, and the Trilogy Transcatheter Heart Valve System. These devices are designed for use in catheter-based procedures to implant heart valves in patients with aortic stenosis, requiring compatible sheaths, catheters, and deployment tools. The system is intended for use under fluoroscopic guidance by trained physicians experienced in TAVR.

The Trilogy portfolio is classified as Class III medical devices, requiring premarket approval (PMA) in the US and registration in the EU’s EUDAMED database. The company is based in the United States, and its devices are listed under the FDA’s PMA pathway and the EU’s eudamed registry.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

AI-generated from registry data and not verified by a human reviewer.