The following information relates to Aerin Medical products available for sale in the United States.
INDICATIONS FOR USE
The VivAer Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, including cartilage in the internal nasal valve area.
INTENDED USER
The intended users of the VivAer Stylus are physicians including otolaryngologists, maxillofacial surgeons and other physicians specialized in nasal procedures.
CONTRAINDICATIONS
Patients who have had nasal surgery within the last 3 months.
Patients with extreme nasal pathology or a history of extreme nasal injuries.
Patients with medical conditions that may impair normal healing processes or be exacerbated by the stress of surgery.
INDICATIONS FOR USE
The RhinAer Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.
INTENDED USER
The intended users of the RhinAer Stylus are physicians including otolaryngologists, maxillofacial surgeons and other physicians specialized in nasal procedures.
CONTRAINDICATIONS
Patients who have had nasal surgery within the last 3 months.
Patients with extreme nasal pathology or a history of extreme nasal injuries.
Patients with medical conditions that may impair normal healing processes or be exacerbated by the stress of surgery.
Common side effects related to the use of radiofrequency energy on tissue in the nose include mild bleeding, redness, temporary swelling, temporary numbness/tingling at the treatment area, temporary soreness/pain, blanching (white appearance of tissue), disruption of mucus such as crusting, changes to the nasal membrane (the lining of the nasal cavity), sensory changes (smell) at treatment site, bruising including around the eye(s) (black eyes). Less common side effects include infection, severe bleeding, scar formation at the treatment site with increased obstruction, and change in external shape or appearance of the nose.
NOTE: Specific indications, contraindications, warnings, precautions and safety information exist for these products. Aerin Medical relies on the physician to determine, assess and communicate to each patient all foreseeable risks of the procedure. A physician must always refer to the package insert, product label and/or instructions for use before using any of Aerin Medical’s products. Rx only.
