Laser Delivery SystemThe SideLaze800 delivery system allows for use of a 1440nm�wavelength�through�a�fiber�protruding�2mm�from the tip of a 2mm microcannula. In this report, the 1440nm wavelength was selected for laser lipolysis�and�shallow�heating�of�collagen�fibers�(water)�within the dermis and septae. The SideLaze800 fiber�is�designed�to�deliver�energy�in�a�bidirectional�manner. This emission design permits targeted delivery of laser energy to the structures of interest. An accelerometer (SmartSense™), a motion-sensing device, was attached to the laser handpiece to

prevent�excessive�thermal�deposition�by�regulating�uniform�energy�delivery�in�the�treated�tissues,�based�on�motion-feedback�microchip�technology.�

When the surgeon decelerated the reciprocating movement of the handpiece, the amount of energy was reduced automatically to ensure a safe�level�of�power�distribution.�To�control�tissue�heating, two additional systems were employed with the SmartSense to monitor and regulate real-time�temperatures�during�bilayered�treatments.�First,�the�ThermaGuide™�system�recorded�subdermal�

White Paper

Clinical Experience using the1440nm Wavelength with SideLaze800™ Delivery System for Facial Contouring Gordon H. Sasaki, MD, FACS Professor, Loma Linda Medical University Center Private Practice: Pasadena, California USA

IntroductionThe recent adoption of the 1440nm Neodymium YAG wavelength laser (Cynosure, Inc., Westford, MA), allows for use in areas such as the face, for tissue rejuvenation.1-3 The longer 1440nm wavelength provides�increased�and�localized�photothermal�and�photomechanical�(microbubbling)�effects�on�fatty�tissue�and�collagen�fibers�(water),�achieving�twenty�times�more�absorption�in�adipose�tissue�than�the�1064nm/1320nm—and�forty�times�more�absorption�than�924nm/980nm�wavelengths.4 In a randomized, controlled�study�on�the�lower�half�of�the�abdomen,5�acute�histologic�findings�with�the�1440nm�wavelength�energy�(1000J)�in�the�deep�subcutaneous�fatty�tissue�(10-20mm�below�the�dermal-fat�junction)�demonstrated marked immediate fat-cell disruption and necrosis and profound collagen denaturation in the reticular dermis and septae. When the 1440nm wavelength energy was delivered in the shallow depth of�the�subdermal�fatty�tissue�(‹5mm�depth),�significant�acute�denaturation�was�confined�to�the�collagen�fibers�in�the�reticular�dermis�and�septae,�at�skin�temperatures�between�40-42°C�with�10W�(830�joules).�At�the�sixth�week,�progressive�collagen-fiber�fibrosis�and�reorganization�within�the�reticular�dermis�and�septae�were�observed�histologically�and�are�believed�to�contribute�to�delayed,�optimal�tissue�tightening*�at�three�months and thereafter.

The�purpose�of�this�white�paper�is�to�report�the�early�experience�with�the�1440nm�wavelength�in�combination�with the SideLaze800™�delivery�system,�including�a�side-firing�fiber�for�facial�contouring,�primarily�to�the�lower�third of the midface and neck.

Ana Tevez, Surgical RN Pasadena, CA. USA

Connie Ha, LVN Pasadena, CA. USA

Erica Lopez Ulloa, CST Pasadena, CA. USA

Chelsea Knutson, CST Pasadena, CA. USA

Margaret Gaston, Computer Analyst Pasadena, CA. USA

temperature changes with a temperature sensor located at the tip of the cannula. The ThermaGuide system�was�set�to�an�alarm�temperature�of�47°C�that�reflected�a�superficial�skin�temperature�between�40-42°C,�optimal�for�collagen�denaturation�and�later delayed tissue tightening.1-3*�When�the�local�temperature reading exceeded the limit, the laser system would stop, resuming again only when the temperature�decreased�below�47°C—or�when�the�laser�fiber�was�moved�to�cooler�temperature�areas.�Second, an infrared thermal camera (FLIR ThermCAM E45,�Niceville,�Florida)�was�used�to�obtain�continuous�skin�temperatures�between�40-42°C�and�ensure�a�uniform, real-time delivery of heat via a depiction of�a�confluent�orange-red�coloration�within�each�treatment site.

Clinical Protocol Patients with isolated accumulations of fat to the lower third of the face and neck and mild to moderate tissue laxity were selected for laser lipolysis and tissue tightening1-3*�with�the�1440nm�wavelength,�utilizing the SideLaze800™ delivery system. The procedure was recommended in patients without strong�and�apparent�vertical�platysmal�bands.�Patient exclusion criteria included pregnancy, uncontrolled�diabetes�mellitus,�collagen�disorders,�significant�cardiovascular�diseases,�bleeding�disorders, smokers, and those having previous surgical procedures within a year to the current treatment sites.�All�subjects�were�consented�for�their�office�procedures under local anesthesia treatments. Subjective�aesthetic�assessments�included�the�Global�Aesthetic�Improvement�Scale�and�a�patient�satisfaction questionnaire at the third- and sixth-month follow-up period.

After preoperative standardized digital photography, treatment sites were marked into one 5x5cm square lateral to each marionette line and three 5x5cm squares�across�the�entire�neck.�Subjects�received�oral�premedication and skin preparation with povidine-iodine (Betadine) washes. Tumescent solution, consisting of 500mg lidocaine, 1mg epinephrine, 20ml,�8.4%�sodium�bicarbonate�per�liter�of�normal�saline�was�infiltrated�into�the�deep�and�superficial�subcutaneous�fat�layers.�Lasing�began�about�20�minutes later to allow for diffusion of tumescent infiltrate�and�maximum�vasoconstriction�through�two�

‹1cm�postlobular�and�a�‹1cm�submental�incisions.�

First, laser energy was delivered within the deep subcutaneous�fat�in�each�square.�Second,�liposuction�with a 1.2mm cannula to the lower third of the face or�with�a�3.2mm�flat�cannula�to�the�neck�removed�the�liquefied�fat�and�tissue�debris�under�a�vacuum�pressure of 450-500mm Hg. This allowed for immediate contour assessment and created an evacuated environment that facilitated more rapid elevation of�threshold�subdermal�temperatures�during�the�subsequent�shallow�lasering.�Third,�shallow�subdermal�treatment�distributed�laser�energy�in�each�square,�achieving�the�targeted�skin�temperatures�between�40-42°C.�Temporary�¼�inch�penrose�drains�were�inserted�into�each�post-lobule�incision�site�and�removed within 24 hours. Compression garments with sponge inserts were applied for 7-10 days, after which a series of weekly external ultrasound treatments were administered to reduce irregularities and swelling.

Results Between�September�2010�and�May�2011,�twelve�consecutive patients (two men, ten women; 41-74 years old, mean age 53.3) were indicated for laser lipolysis and improvement in fat contour and tissue tightening*�at�jowl�and�neck�regions.1-3 (Table�1).�The mean pretreatment weight was 78.8 kg (range 46.6-103.6�kg)�with�a�mean�body�mass�index�of�29.5 (range 20.5-36.9). At the third- and sixth-month evaluation�period,�there�was�no�significant�change� in�the�baseline�weights�and�body�mass�indices.�

An average of 200ml of tumescent solution (range125-280)�was�infiltrated�into�the�deep�and�superficial�subcutaneous�layers�within�the�lower�third of face and entire neck. This total volume was equal�to�about�30-50ml�within�each�5x5cm�square.�Within�the�deep�subcutaneous�fat�in�each�square,�the delivered energy ranged from 6-10 Watts at 25 Hz, averaging 695 joules per 5x5cm square (range 500-1044 joules per 5x5 cm square). The endpoints of treatment were determined when: (1) the average�number�of�joules�was�between�500-700�per�square,(2) the ThermaGuide temperature consistently measured�around�47°C�whereas�skin�temperatures�measured�between�38°-42°C;�and�(3)�increased�ease�of�passing�the�firing�laser�fiber�through�the�tissues.�Depending�on�preoperative�findings,�liposuction�

removed�between�50-125ml�aspirate,�of�which�about�55%�per�volume�consisted�of�fat.�Shallow�subdermal�heating�distributed�an�average�of�285�joules per 5x5cm square (range 250-400 joules per 5x5cm�square)�at�1-5mm�below�the�dermis.�The�total�average�joules�(deep�and�superficial)�delivered�per�patient�was�about�5565,�which�translated�to�about�1030 joules per 5x5 cm square. Because elevated skin�temperatures�returned�to�baseline�levels�within�2-5 minutes after termination of shallow lasing, the skin was rechallenged with additional lasing to temperatures�between�38-42°C�for�possible�increased�tissue tightening through tissue coagulation1-3,�based�on�clinical�findings.�The�¼�inch�Penrose�drains�were�removed within 24 hours to facilitate drainage of residual�fluids.�The�surgical�time�averaged�about�one hour (range 45-75minutes), with postoperative recovery less than an hour. Compression garments were worn for another 10 days to prevent any incidence of seroma formation.

Outcomes And Side EffectsPatients�were�very�satisfied�with�their�results,�especially�in�the�definition�of�their�mandibular-neck�outlines�with�reduction�of�the�prejowls�and�submental�fullness�(Figures�2-4).�The�incidence�of�bruising�and�swelling�was low and resolved completely within two weeks. No patients developed hematomas, sensory or motor nerve�injuries,�striations,�blisters�or�dyschromias�after�dual layers of treatment. Three patients developed small�fibrous�nodules�within�the�subcutaneous�fat in the neck that resolved within 6 weeks with postoperative ultrasound treatments. Postoperative discomfort was mild to moderate, with patients using analgesic products such as extra-strength acetaminophen or lowest doses of hydrocodone/acetaminophen.�Most�patients�were�able�to�resume their levels of presurgical activities within two�weeks.�There�were�no�unanticipated�significant�adverse�events.�Patients�experienced�about�an�80%�improvement�by�three�months,�with�progressive�tissue�tightening*�and�contouring�thereafter�until�six�months. Patients were asked to evaluate their overall satisfaction at 3 and 6 months after treatment on a five-point�scale�(0,�worse;�1,�no�change;�2,�mild;�3,�moderate; 4, excellent). The mean score at three months was 2.5 with improvements in fat reduction and tissue laxity. The mean score at six months

increased�to�3.5�with�continued�progressive�definition�through�tissue�tightening*.�Ultrasound�imaging�and�measurements from one patient (Figure 1) taken pre and 3 months post SideLaze800 treatment represented intensity change of the dermis with enhanced collagen depositions from 1.40mm pre to 1.81mm 3 months post treatment representing an increase in skin thickness of 29%. All patients would recommend the procedure to others.

Discussion Laser-assisted lipolysis and tissue tightening through coagulation for facial and neck contouring can be�performed�efficiently�utilizing�the�advantages�of�the�side-firing�1440nm�wavelength�to�produce�selective fat destruction and collagen denaturation in septal and dermal structures for eventual tightening through coagulation.5 A Monte Carlo simulation study6 with three different wavelengths (1064nm, 1320nm, and 1440nm) demonstrated that the 1440nm wavelength produced the highest fat�and�dermal�tissue�ablation�efficiency,�with�minimal localization of heat over depth, compared to the other two wavelengths. A recent study5 on the acute and delayed histo-logical changes after 1440nm, 1320nm and 1064nm wavelength exposures�in�the�deep�and�superficial�layers�in�human�abdominal�tissue,�confirmed�the�Monte�Carlo�simulation�observations.�The�present�clinical�experience demonstrated persistence of clinical benefits�at�six�months�in�all�patients�by�objective�and�subjective�analyses.�Adverse�events�were�limited�to�transient�swelling�and�bruising,�the�severity�of�which�was�mild�and�completely�resolved�by�2-3�weeks.�

Before After 3 Months Figure 1��Measurements�taken�from�above�ultrasound�represent�enhanced collagen depositions from 1.40mm pre to 1.81mm 3 months post treatment, representing an increase in skin thickness of 29%.

Table 1. Demographic Data

Patient # Sex Age Ethnicity Weight (kg) BMI

1 female 46 Caucasian 73.0 26.8

2 female 56 Caucasian 82.1 26.0

3 female 50 Latina 70.3 25.8

4 male 65 Asian 87.1 31.9

5 female 50 Latina 84.4 32.9

6 female 41 Latina 79.9 30.8

7 female 53 Caucasian 103.6 36.9

8 female 74 Caucasian 46.6 20.5

9 female 60 Caucasian 53.5 22.3

10 female 42 Latina 80.7 32.6

11 female 42 Latina 88.5 36.8

12 male 60 Caucasian 95.3 31.0

MEAN 53.5 - 78.8 29.5

Treatment�burns�were�not�observed�because�the�internal and skin temperatures were monitored in real�time.�The�treatment�endpoint�was�the�number�of joules of energy delivered and the skin surface temperature.

Conclusion The incorporation of the1440-nm wavelength delivered�through�a�side-firing�fiber,�SideLaze800,� achieved effective laser lipolysis and tissue tightening through coagulation for facial contouring in twelve patients who presented fat accumulations in the lower third of their faces and neck. Most of these patients�exhibited�moderate�degrees�of�tissue� laxity and sagging. Photographic analyses and�positive�responses�from�Global�Aesthetic�Improvement Scale indicated that the 1440-nm wavelength�achieved�high�thermal�absorption� within fat and collagen (water) leading to laser-assisted lipolysis and collagen denaturation, and�progressive�tissue�tightening*�by�3-6�months.�The�combination�of�the�1440-nm�wavelength,�SideLaze800�side-firing�fiber,�and�the�thermal-control�systems provided a safer and more effective means for facial contouring. Further studies are needed to validate�these�initial�findings.�

Figure 2��This�65-year-old�patient�presented�with�significant�fat�accumulations�to�the�jowls�and�neck�with�marked�tissue�laxity.�Preoperative�markings�delineate�the�5x5cm�squares�to�be�treated�(deep�1045�j/square;�superficial�350�j/square;�skin�temperature�during�shallow�treatment�39°C);�175�cc�lipoaspirate).�

BEFORE

BEFORE

AFTER 6 Months

AFTER 6 Months

Figure 3��This�50-year-old�patient�presented�with�significant�fullness�to�the�prejowl�areas�and�to�her�entire�neck,�with�a�moderate�degree�of�tissue�laxity.�Preoperative�markings�delineate�the�5x5cm�sites�to�be�treated�(deep�500j/square;�superficial�223j/square;�skin�temperature�during�shallow�treatment�38°C;�125ml�lipoaspirate).�

BEFORE AFTER 6 Months

BEFORE AFTER 6 Months

BEFORE AFTER 6 Months

Figure 4 This 50-year-old patient presented with a moderate amount of fullness to her prejowl and neck areas with moderate tissue laxity. Skin�markings�delineated�the�treated�sites�(Four�5x5�cm�sites�treated�deep�500j/square�and�superficial�400j/square;�two�3x5�sites�treated�deep�500j/square�and�superficial�400j/square;�skin�temperature�during�shallow�treatment�38°C;�50�cc�lipoaspirate).�The�subject�maintained�their�bodyweight.��

BEFORE AFTER 6 Months

© 2012 Cynosure, Inc. Cynosure is a registered trademark of Cynosure, Inc. SideLaze800, SmartSense and ThermaGuide are trademarks of Cynosure, Inc. All other trademarks acknowledged. 921-0269-000 Rev.3 06/12

www.cynosure.com

CONFLICT OF INTEREST STATEMENT

Dr. Sasaki is a consultant for Cynosure and received limited funding under an unrestricted research grant for the study.

References 1. Sasaki GH. Laser-Assisted Liposuction for Facial and

Body Contouring and Tissue Tightening: a 2 Year Experience with 75 Consecutive Patients. Seminars in Cutaneous Medicine and Surgery 2009; 28(4):226-235.

�2.� �Sasaki�GH.�Quantification�of�Human�Abdominal��Skin�Tightening and After Component Treatments with 1064nm/1320nm Laser-Assisted Lipolysis: Clinical Implications. Aesth Surg J 2010; 30(2): 239-245.

3.� �Sasaki�GH.�The�significance�of�Shallow�Thermal�Effects from 1064/1320nm Laser on Collagenous Fibrous�Septae�and�Reticular�Dermis:�Implications�for�Remodeling and Skin Tightening. White Paper 2009.

4. Duck FA. Physical Properties of Tissue. San Diego, Ca. Academic Press, 1990, pp 320 -328.

5. Sasaki GH, Tevez A, Gonzales M. Histological Changes after 1440nm, 1320nm and 1064nm Wavelength Exposures�in�the�Deep�and�Superficial�Layers�of�Human�Abdominal�Tissue:�Acute�and�Delayed�Findings.�White Paper 2010.

6.� �Youn�J.�Ablation�Efficiency�Measurements�for�Laser-Assisted Lipolysis Using Optical Coherence Tomography. Lutronic Corporation.�February�2009�