The following information relates to Aerin Medical products available for sale in the United States.
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.
The intended users of the VivAer Stylus are physicians including otolaryngologists, maxillofacial surgeons and other physicians specialized in nasal procedures.
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.
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.
The intended users of the RhinAer Stylus are physicians including otolaryngologists, maxillofacial surgeons and other physicians specialized in nasal procedures.
Common adverse effects related to the use of radiofrequency energy on tissue in the nasal airway include mild bleeding, mucosal necrosis, sensory changes at treatment site, inflammation/generalized redness, temporary swelling/edema, blanching (generalized whiteness), temporary numbness/tingling, bruising including around the orbital area (black eyes), temporary soreness/pain, and disruption of mucosal flow/crusting.
Less common adverse effects include serious bleeding (nosebleed), scar formation with increased obstruction, external deformity, and infection.
Serious nosebleed is rare, but a potential side effect, and may be increased if the patient has a clotting disorder, uncontrolled high blood pressure, or uses anticoagulants or blood thinners.
Serious bleeding requiring surgery or endovascular intervention may occur as late as 2 months following treatment with RhinAer Stylus.
The REACH Needle is used for injection local anesthetics into a patient to provide regional anesthesia.
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.
