Preclinical Results

REVOLVE™ System yielded a higher concentration of adipose tissue.1

REVOLVE™ System minimized potential inflammatory response by eliminating free oil and significantly removing tumescent fluid and cell debris.

REVOLVE™ System yielded predictable results.1

REVOLVE™ System produced significantly higher fat graft retention than decant method and similar results to centrifugation.



Correlation of these results to results in humans has not been established.


Clinical Outcomes
Time Savings

In retrospective cohort studies, REVOLVE™ System was shown to save significant operating room time and provide potential savings in large volume procedures compared to centrifugation.2,3


The study included a total of 96 patients in the centrifugation group and 98 patients for REVOLVE™ System group. Average Rate of Fat Transfer was based on mean volume of fat injected per time spent from lipoaspiration to injection.


The study included 37 patients over a 6-month period, including 13 Coleman technique patients, and 24 REVOLVE™ System patients. The average rate of fat transfer was 1.77 cc/min for Coleman and 4.69 cc/min for REVOLVE™ System, which was a statistically significant difference between groups.



Clinical Outcomes
Reduced Complications2

Significantly less nodule and cyst formations were observed in the REVOLVETM System group versus the centrifugation group.

Fat necrosis between groups was not statistically different.

Significantly fewer reoperations to add soft tissue to the breast were observed in the REVOLVETM System group versus the centrifugation group.



The study was a retrospective cohort of consecutive patients who underwent autologous fat grafting during reconstructive breast surgery with REVOLVE™ System (N=98) or centrifugation (N=96). The endpoints measured included: volume of lipoaspirate and volume injected after processing, time to complete processing, reoperations, and complications.


REVOLVETM System Important Safety Information 
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™ System is available by prescription only.

For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVE™ System.

To report an adverse reaction, please call Allergan at 800.367.5737.

REVOLVETM System Important Safety Information 
REVOLVETM System Important Safety Information 
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™ System is available by prescription only.

For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVE™ System.

To report an adverse reaction, please call Allergan at 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™ System is available by prescription only.

For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVE™ System.

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

References: 1. Ansorge H, Garza JR, McMormack MC, et al. Autologous fat processing via the Revolve System: quality and quantity of fat retention evaluated in animal model. Aesthet Surg J. 2014;34(3):438-447. 2. 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. 3. Brzezienski MA, Jarrell JA 4th. Autologous fat grafting to the breast using Revolve System to reduce clinical costs. Ann Plast Surg. 2016;77(3):286-289.