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Indication

The Pacira Pharmaceuticals, Inc. iovera° System is a cryosurgical device for treating superficial and subcutaneous tissue structures. Applications include temporary wrinkle reduction, temporary pain reduction, treatment of dermatologic conditions, and focal cryo-treatment of tissue.

The Pacira Pharmaceuticals, Inc. iovera° System is a handheld cryosurgical device designed for physicians treating superficial and subcutaneous tissue structures. The iovera° System delivers Focused Cold Therapy to target tissues for the following applications:

• Focal cryo-treatment of tissue and treatment of dermatologic conditions (i.e., ablation of unwanted tissue);
• Cryosurgical treatment of superficial nerves to create nerve blockade by cryodenervation of the innervating nerve branch (i.e., blocking of sensory nerves for pain management) and blocking of motor nerves for reduction in muscle movement associated with the appearance of hyper-dynamic facial wrinkles.

The intended users of the Pacira Pharmaceuticals, Inc. iovera° System are medical experts such as physicians and specialists in a medical setting such as an operating room or doctor’s office. The device is not intended for home use, or lay person use.

Important Safety Information

Contraindications

The iovera° System is contraindicated for use in patients with the following:

• Cryoglobulinemia
• Paroxysmal cold hemoglobinuria
• Cold urticaria
• Raynaud’s disease
• Open and/or infected wounds

Potential Complications

As with any surgical treatment that uses needle-based therapy and local anesthesia, there is a potential for site-specific reactions, including, but not limited to:

• Ecchymosis, edema, erythema, local pain and/or tenderness, and localized dysesthesia

Proper use of the device as described in the User Guide can help reduce or prevent the following complications:

• At the treatment site(s): injury to the skin related to application of cold or heat, hyper- or hypopigmentation, and skin dimpling
• Outside the treatment site(s): loss of motor function