• In some cases, initial treatment with RENÚ® injectable implant may not be effective and additional injections may be indicated.
• RENÚ® injection procedure and the associated instrumentation procedures have small but inherent risks of infection and/or bleeding like similar minimally invasive procedures. The patient may experience slight discomfort during and following the procedure. The usual precautions associated with tissue injection procedures, should be followed.
• Care should be taken with the injection of RENÚ® tissue Implant, as with any surgical or implantation procedure, to avoid infection during the injection procedure.
• The CaHA particles of the injectable implant are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography. Patients need to be informed of the radiopaque nature of CaHA based injectable implant, so that they can inform their primary care health professionals as well as radiologists.
• Safety of RENÚ® injectable implant for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
Important: For full safety information, please see the product IFU or call RegenScientific Customer Service at 855-433-2765
RENÚ® is available through licensed physicians only.