REVOLVE™ SYSTEM: DESIGNED FOR
EASE AND PREDICTABILITY1,2*

*Correlation between these results and results in humans has not been established.

PRODUCT ATTRIBUTES

TIME EFFICIENT2

  • Processes up to 350 mL of adipose tissue (~ 700 mL of lipoaspirate) in under 10 minutes1,3
  • Proven to save time and potential costs compared to centrifugation4
  • All-in-one integrated device that harvests, processes, and extracts lipoaspirate within 1 canister1

INTEGRATED,
CLOSED SYSTEM

  • Minimizes tissue handling and exposure to outside air
  • Controls critical fat grafting variables, such as pH, osmolarity, and contaminants
  • Sterile, single-patient, disposable device

EASY TO USE

  • User-friendly system minimizes training, preparation, and clean-up time, requiring only 1 operator
  • Can be placed in the sterile field, in line with aspiration and waste devices
  • Integrated system allows loading of syringes for injection directly from canister1

REVOLVE™ System is intended for use in the following surgical procedures when aspiration of soft tissue is desired5:

  • Plastic and reconstructive surgery
  • Gastrointestinal and affiliated organ surgery
  • Urological surgery
  • General surgery
  • Orthopedic surgery
  • Gynecological surgery
  • Thoracic surgery
  • Laparoscopic surgery

Contraindications include the presence of any disease processes that adversely affect wound healing, and poor patient health.5

INDICATIONS
The REVOLVE™ Advanced Adipose System (REVOLVE™ System) is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. This system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE™ System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS
Contraindications to autologous fat transfer include the presence of any disease processes that adversely affect wound healing, and poor overall health status of the individual.


WARNINGS
REVOLVE™ System must be used within the same surgical procedure. Reuse of this device in the same patient in a subsequent surgical procedure, or for more than one patient, may result in infection and/or transmission of communicable diseases. Do not use the product if sterile packaging is damaged.

This device will not, in and of itself, produce significant weight reduction. This device should be used with extreme caution in patients with chronic medical conditions such as diabetes, heart, lung, or circulatory system disease or obesity. The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety.


PRECAUTIONS
REVOLVE™ System is designed to remove localized deposits of excess fat through small incision and subsequently transfer the tissue back to the patient. Use of this device is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty and tissue transfer. Results of this procedure will vary depending upon patient age, surgical site, and experience of the physician. Results of this procedure may or may not be permanent. The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect. Filling the device with adipose tissue over the maximum fill volume line can lead to occlusion of the mesh resulting in mesh tear.


ADVERSE EFFECTS
Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or under-correction of the treatment site, tissue lumps, bleeding, and scarring. Potential adverse effects associated with REVOLVE™ System include fat necrosis, cyst formation, infection, chronic foreign body response, allergic reaction, and inflammation.


REVOLVE TM System is available by prescription only.

For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVETM System available at www.allergan.com/RevolveIFU or call 1.800.678.1605

To report an adverse reaction, please call Allergan at 1.800.367.5737.

INDICATIONS
The REVOLVE™ Advanced Adipose System (REVOLVE™ System) is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. This system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE™ System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.


IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS
Contraindications to autologous fat transfer include the presence of any disease processes that adversely affect wound healing, and poor overall health status of the individual.


WARNINGS
REVOLVE™ System must be used within the same surgical procedure. Reuse of this device in the same patient in a subsequent surgical procedure, or for more than one patient, may result in infection and/or transmission of communicable diseases. Do not use the product if sterile packaging is damaged.

This device will not, in and of itself, produce significant weight reduction. This device should be used with extreme caution in patients with chronic medical conditions such as diabetes, heart, lung, or circulatory system disease or obesity. The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety.


PRECAUTIONS
REVOLVE™ System is designed to remove localized deposits of excess fat through small incision and subsequently transfer the tissue back to the patient. Use of this device is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty and tissue transfer. Results of this procedure will vary depending upon patient age, surgical site, and experience of the physician. Results of this procedure may or may not be permanent. The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect. Filling the device with adipose tissue over the maximum fill volume line can lead to occlusion of the mesh resulting in mesh tear.


ADVERSE EFFECTS
Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or under-correction of the treatment site, tissue lumps, bleeding, and scarring. Potential adverse effects associated with REVOLVE™ System include fat necrosis, cyst formation, infection, chronic foreign body response, allergic reaction, and inflammation.


REVOLVE TM System is available by prescription only.

For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVETM System available at www.allergan.com/RevolveIFU or call 1.800.678.1605

To report an adverse reaction, please call Allergan at 1.800.367.5737.

References:

1. Ansorge H, Garza JR, McCormack MC, et al. Autologous fat processing via the Revolve system: quality and quantity of fat retention evaluated in an animal model. Aesthet Surg J. 2014;34(3):438-447. 2. Data on file, Allergan, July 2008. Research and Development Report. 3. REVOLVE System Instructions for Use, 2017. 4. Gabriel A, Maxwell GP, Griffin L, Champaneria MC, Parekh M, Macarios D. A comparison of two fat grafting methods on operating room efficiency and costs. Aesthet Surg J. 2017;37(2):161-168. 5. REVOLVE System User Manual, 2017.

REVOLVE™ and its design are trademarks of LifeCell Corporation, an AbbVie company. All other trademarks are the property of their respective owners.

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