Southmedic s Dynamic Tissue Systems. Control Reduce Close

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1 Southmedic s Dynamic Tissue Systems Control Reduce Close

DynaCleft + Nasal Elevator Evidence-based pre-surgical treatment of cleft lip and palate and nasal deformity Proven as effective as NAM in pre-surgically approximating unilateral cleft lip and

improve nasal symmetry and better positions a cleft lip and palate for optimal surgical results.

intra-oral plate Easy to apply and manage, increasing parental compliance with treatment Significant cost savings compared to NAM Nasal Elevator Clinical Benefits* Improves nasal symmetry Lengthens

DynaCleft tapes, NAM or any intra-oral plate Baby and Parent Benefits Pre-surgical positioning of lip and palate optimizes cosmetic and functional outcomes Easy at-home treatment minimizes clinical

2 DynaCleft + Nasal Elevator Evidence-based pre-surgical treatment of cleft lip and palate and nasal deformity Proven as effective as NAM in pre-surgically approximating unilateral cleft lip and palate* Developed in collaboration with Plastic Surgeons, Orthodontists, and Cleft Palate Teams, DynaCleft + NE System gently guides bone and soft tissue while supporting nasal alar cartilage; improve nasal symmetry and better positions a cleft lip and palate for optimal surgical results. DynaCleft Clinical Benefits* Controlled force re-positions prolabium, premaxilla and alvaolar segments for best possible surgical results Can be used alone or in conjunction with NAM, or any intra-oral plate Easy to apply and manage, increasing parental compliance with treatment Significant cost savings compared to NAM Nasal Elevator Clinical Benefits* Improves nasal symmetry Lengthens and straightens the columella Reduces need for primary nasal surgery Reduces length & extent of primary nasal surgery Facilitates nasal breathing Easy for parents to manage at home Can be used with DynaCleft tapes, NAM or any intra-oral plate Baby and Parent Benefits Pre-surgical positioning of lip and palate optimizes cosmetic and functional outcomes Easy at-home treatment minimizes clinical visits - no professional adjustments necessary Does not interfere with feeding Non-invasive treatment maximizes comfort for baby - expands & contracts as baby s mouth moves * 1. COMPARATIVE STUDY OF NASOALVEOLAR MOLDING METHODS: Nasal elevator plus DynaCleft vs. NAM-Grayson in patients with complete unilateral cleft lip-palate. Monasterio L, Ford A, Gutiérrez C, Tastets M, García J. (Cleft Palate Craniofac J. Vol. 50 No. 5 Sept 2013: ) 2. THE NASAL ALAR ELEVATOR: An effective tool in the presurgical treatment of infants born with cleft lip. Berggren A, Abdiu A, Marcusson A, Paulin G. (Plast Reconstr Surg. Vol. 115 No.6 May 2005: ) 3. THE NASAL ALAR ELEVATOR: A new device that may reduce the need for primary operation of the nose in patients with cleft lip. Abdiu A, Ohannessian P, Berggren A. (Scand J Plast Reconstr Surg Hand Surg. Vol.43 No : 71-4s)

SutureSafe Dynamic Incision Management Creating a low-tension healing

of surgical site infections, complications and dehiscence Bridges the

skin tension isolating the wound and allowing movement without pain

3 SutureSafe Dynamic Incision Management Creating a low-tension healing environment Indications Early incision management to reduce the risk of surgical site infections, complications and dehiscence Bridges the suture line, dynamically holding wound margins together Normalizes skin tension isolating the wound and allowing movement without pain Prevents dehiscence Reduces scarring Maintain constant wound visibility

DynaStretch Topical Pre-operative Skin Expansion Topical skin expansion is a common surgical procedure to grow extra skin through controlled mechanical overstretch.

Area marked for excision DynaClose s gentle, but unrelenting tension makes it ideal for stretching skin prior to a surgical intervention, creating a depot of skin that allows a primary closure after

The inherent elasticity of both the adhesive fabric and the silicone elastomer allow patient mobility as the device works.

Applied topically (atraumatic) Significantly improves cosmetic results Pre-surgical skin expansion using ABRA Adhesive Skin Closure enabled wide excision and subsequent primary closure of cutaneously

4 DynaStretch Topical Pre-operative Skin Expansion Topical skin expansion is a common surgical procedure to grow extra skin through controlled mechanical overstretch. It creates skin that matches the color, texture, and thickness of the surrounding tissue, while minimizing scars and rejection risks. Area marked for excision DynaClose s gentle, but unrelenting tension makes it ideal for stretching skin prior to a surgical intervention, creating a depot of skin that allows a primary closure after defect or flap excision. DynaClose's tension aligns collagen fibers and encourages new cell generation. The inherent elasticity of both the adhesive fabric and the silicone elastomer allow patient mobility as the device works. DynaStretch applied Topically applied in office 1-2 weeks pre-op Patient managed until day of surgery Enables primary skin closure after excision surgery Eliminates multi-staged surgical procedures Applied topically (atraumatic) Significantly improves cosmetic results Pre-surgical skin expansion using ABRA Adhesive Skin Closure enabled wide excision and subsequent primary closure of cutaneously based malignancies in many anatomical locations 1 ABRA Adhesive Skin Closure was used to pre-surgically expand skin around an 8.5x7.5cm scalp defect to allow complete excision and primary closure 2 Defect removed 1. Peri- and Preoperative Use of Adhesive Skin Expanders Can Facilitate Resection and Improve Cosmesis in the Management of Selected Cutaneous Malignancies. Hristov H, George R. Division of Surgical Oncology, Cancer Centre of Southeastern Ontario and Queen s University, Kingston, ON, Canada. 2. Scalp Expansion with the Canica Wound Closure System: First case report. Dal Cin A, Seal SKF. Canadian Journal of Plastic Surgery Winter;14(4):

DynaClose Topical Skin Closure - Close Wounds without Grafts or Negative Pressure DynaClose provides an

DynaClose provides a second chance at skin closure for failing wounds, wounds under tension, wounds at risk

An elastic adhesive fabric bonds to the skin while a silicone elastomer progressively pulls the wound

Pulls open wounds closed Achieves primary closure without sutures, staples, grafts or negative pressure For

5 DynaClose Topical Skin Closure - Close Wounds without Grafts or Negative Pressure DynaClose provides an easy, painless and non-invasive method to close retracted or dehisced wounds up to 5cm in width. DynaClose provides a second chance at skin closure for failing wounds, wounds under tension, wounds at risk of dehiscing, or when reduction of wound area under management is desirable. An elastic adhesive fabric bonds to the skin while a silicone elastomer progressively pulls the wound margins together. Compatible with current wound care protocols. Pulls open wounds closed Achieves primary closure without sutures, staples, grafts or negative pressure For use above and below wound dressings Ensures high tension incisions remain closed Reduces pain by relieving incisional tension Promotes patient mobility Failed primary closure DynaClose applied Healed - No sutures

$Indications Retracted skin defects Fasciotomies Compound fracture wounds Dehisced wounds Pediatric wounds Reinforcing high tension closures Sternotomies Hallmarks Achieves primary closure Eliminates$ needs for grafts and flaps Improves cosmesis Promotes patient mobility Reduces LOS and OR procedures Value Proposition Early results with ABRA Adhesive Skin Closure demonstrated cosmetically

needs for grafts and flaps Improves cosmesis Promotes patient mobility Reduces LOS and OR procedures Value Proposition Early results with ABRA Adhesive Skin Closure demonstrated cosmetically

2 The staged closure of a giant neonatal omphalocele with ABRA Adhesive Skin Closure shows that it may also prove useful in the treatment of other congenital tissue defects 3 1.

6 ABRA Adhesive Skin Closure Systems The ABRA Adhesive Skin Closure System provides non-invasive skin closure of retracted skin defects, leaving nothing behind except a sound primary repair. Indications Retracted skin defects Fasciotomies Compound fracture wounds Dehisced wounds Pediatric wounds Reinforcing high tension closures Sternotomies Hallmarks Achieves primary closure Eliminates needs for grafts and flaps Improves cosmesis Promotes patient mobility Reduces LOS and OR procedures Value Proposition Early results with ABRA Adhesive Skin Closure demonstrated cosmetically acceptable, delayed primary closure of difficult fasciotomy wounds 1 On an outpatient basis, using only ABRA Adhesive Skin Closure, sternal wound infections were closed without additional procedures 2 The staged closure of a giant neonatal omphalocele with ABRA Adhesive Skin Closure shows that it may also prove useful in the treatment of other congenital tissue defects 3 1. Early Results Using a Dynamic Method for Delayed Primary Closure of Fasciotomy Wounds. Taylor RC, et al. Journal of the Americal College of Surgeons Nov;197: Elastic Device Facilitating Delayed Primary Closure of Sternal Wound Infection. Price J, et al. Annals of Thoracic Surgery Mar;83: Management of a Giant Omphalocele with an External Skin Closure System. Baird R. et al. J Pediatric Surgery Jul;45(7):E17-20.

ABRA Surgical Skin Closure Systems The ABRA Surgical Skin Closure System engage full-thickness skin and closes high-tension, retracted skin defects, leaving nothing behind except a sound primary

$Indications Retracted skin defects Fasciotomies Compound fracture wounds Abdominal skin closure over mesh or hernia Hallmarks Normalized compartment pressure Restores normal skin integrity Achieves a$ 6 days at 91% rate* Fasciotomies were closed primarily in an average of 2.

6 days at 91% rate* Fasciotomies were closed primarily in an average of 2.

7 ABRA Surgical Skin Closure Systems The ABRA Surgical Skin Closure System engage full-thickness skin and closes high-tension, retracted skin defects, leaving nothing behind except a sound primary repair. Indications Retracted skin defects Fasciotomies Compound fracture wounds Abdominal skin closure over mesh or hernia Hallmarks Normalized compartment pressure Restores normal skin integrity Achieves a primary closure Eliminates the need for mesh, grafts and flaps Reduces LOS and OR procedures Promotes patient mobility Value Proposition Achieves primary closure in 2.6 days at 91% rate* Fasciotomies were closed primarily in an average of 2.6 days using ABRA Surgical Skin Closure, several times faster than standard techniques and instead of covering with grafts 1 ABRA Surgical Skin Closure eliminates the need for skin grafting and provides excellent cosmetic result. Adjustment at bedside minimizes the need for multiple operations 2 Early results with ABRA Surgical Skin Closure demonstrated cosmetically acceptable, delayed primary closure of difficult fasciotomy wounds 3 Fasciotomy wounds were closed in an average of 5.6 days saving an average of $8,062 per patient over other methods 4 Cost savings of up to $28,000 per patient ($5,000 - $28,000 for various age groups), when ABRA is used for fasciotomies 5 * Dynamic wound closure for decompressive leg fasciotomy wounds. Singh N, Bluman E, Starnes B, Andersen C. Vascular Surgery Service, Madigan Army Medical Center, Tacoma, Washington. Am Surg Mar;74(3): Dynamic Wound Closure for Decompressive Leg Fasciotomy Wounds. Singh N. et al. The American Surgeon Mar;74: Delayed Dynamic Abdominal Wall Closure Using Abdominal Re-approximation Anchor (ABRA Device After An Initial Damage Control Laparotomy. Win TS et al. Department of Surgery, Addenbrooke s Hospital, University of Cambridge, United Kingdom. Poster Presentation: 4th World Conference Abdominal Compartment Syndrome, Dublin, Ireland, June 25-27, Early Results Using a Dynamic Method for Delayed Primary Closure of Fasciotomy Wounds. Taylor RC, et al. Journal of the American College of Surgeons Nov;197: Canica Datasheet #1 - The study referenced in #3 was followed by an economic study, also done at The Ottawa Hospital (TOH) where the hospital and homecare costs of primarily closing an extremity fasciotomy with ABRA Surgical Skin Closure were compared against closing with a skin graft or a secondary closure with skin graft. From TOH chart review, fasciotomy wounds were closed in an average of 5.6 days and ABRA Surgical Skin Closure saved an average of $8,062 per patient over the standard treatment methods for fasciotomy closures. 5. Canica Datasheet #2 - Using data from TOH review, the US analysis shows an estimated cost savings of up to $28,000 per patient ($5,000 - $28,000) in the US for the various age groups, when ABRA Surgical Skin Closure is used for fasciotomies.

ABRA Abdominal Wall Closure Systems The ABRA Abdominal Wall Closure System restores the primary closure option or full-thickness, retracted mid-line abdominal defects.

Indications Retracted, full-thickness midline abdominal closure after laparotomy for abdominal compartment syndrome (ACS), abdominal hernia, mesh removal, AAA, or abdominal trauma and for retention

Value Proposition In 92% of cases, full thickness primary closure of complex open abdomens was achieved in an average of 7 days 1-50% reduction in abdominal OR procedures (6.8 vs. 13.

8 ABRA Abdominal Wall Closure Systems The ABRA Abdominal Wall Closure System restores the primary closure option or full-thickness, retracted mid-line abdominal defects. This dynamic tissue management system pulls muscle planes together under low tension while leaving fascial margins intact and ready to suture, for a sound primary closure. Indications Retracted, full-thickness midline abdominal closure after laparotomy for abdominal compartment syndrome (ACS), abdominal hernia, mesh removal, AAA, or abdominal trauma and for retention of abdominal wall closure Hallmarks Eliminates the hernia without the need for mesh and re-approximates the skin margins, eliminating the need to graft Restores domain Restores normal physiology Value Proposition In 92% of cases, full thickness primary closure of complex open abdomens was achieved in an average of 7 days 1-50% reduction in abdominal OR procedures (6.8 vs. 13.7) - 68% reduction in the number of days to any closure (15.8 vs. 50.1) - No skin grafts required when using ABRA vs. 43% of patients without ABRA required skin grafts - Estimated cost reduction of $12,370 to $47,070 per patient) ABRA Abdominal Wall Closure and NPWT is an easy and reproducible option for primary fascial closure following severe Abdominal Compartment Syndrome (ACS) 2 Achieve primary fascial closure following decompressive laparotomy using ABRA Abdominal Wall Closure 3 Using ABRA Abdominal Wall Closure resulted in a 95% reduction in wound area 4 ABRA Abdominal Wall Closure can restore lost abdominal domain and achieve complete repair of the musculofascial support of the abdominal wall, achieving primary closure 5 ABRA uses significantly fewer OR resources, 70% fewer trips to the OR and 76% less OR time because it is adjusted at bedside and allows bedside dressing changes 6 1. Early Primary Closure of Open Abdominal Wounds Using the Abdominal Reapproximation Anchor (ABRA ) System. Cinelli SM, et al. University of Nevada School of Medicine, Division of Trauma and Critical Care, University Medical Center of Southern Nevada, Las Vegas, NV. Poster: Southwestern Surgical Congress, Coronado, CA, March 22-25, Fascial Closure Following Severe Abdominal Compartment Syndrome: A Case Report Regarding an Efficient Combination of Dynamic Abdominal Closure and Negative Pressure Wound Therapy. Ferreira F, et al. Department of Surgery, Hospital Pedro Hispano - ULS Matosinhos, Porto, Portugal. Poster: 4th World Conference Abdominal Compartment Syndrome, Dublin, Ireland, June 25-27, Case Discussion: Secondary ACS Due to Tight Abdominal Closure, Abdominal Compartment Syndrome (WSACS) Newsletter, December 2008, Volume 2, Issue 4. Pages Management of Open Abdominal Wounds using a Dynamic Fascial Closure System. Reimer MW, et all. Canadian Journal of Surgery, 2008 Jun;51(3): Closure of Massive Abdominal Wall Defects - A Case Report Using the Abdominal Reapproximation Anchor (ABRA) System, Urbaniak RM, et al. Annals of Plastic Surgery, 2006 Nov;57: ABRA Abdominal Wall Closure System with V.A.C. Therapy Compared to V.A.C. Alone in Management of Open Abdomen, Hamilton D, et al. University of Kentucky, Department of Surgery, Division of General Surgery, Lexington KY. Poster Presentation: Abdominal Wall Reconstruction Conference, Washington, DC, June 17-19, Southmedic Inc. 50 Alliance Blvd., Barrie, ON L4M 5K3 smedic@southmedic.com Toll free in North America Fax ISO /15 P0110

Dr. N. Retnakumari. MDS, M.Phil, Dr. Manuja Vargheese, Dr. Madhu.S, Dr. Divya. S

Dr. N. Retnakumari. MDS, M.Phil, Dr. Manuja Vargheese, Dr. Madhu.S, Dr. Divya. S IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) e-issn: 2279-0853, p-issn: 2279-0861. Volume 12, Issue 5 (Nov.- Dec. 2013), PP 11-15 A new approach in Presurgical Infant Orthopedics using an Active