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SCIENCE

MIRACU PDO Threads.  Re-Defining Sutures.

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SCIENCE

HISTORY OF PDO THREADS

Historically, the earliest reports of surgical facial rejuvenation date back as far as 1911 by Koll et al. The use of endoscopic malar and midface suspensions were reported by Anderson and Lo et al in 1998 which paved the way for the future use of thread lifting suture technology as a means of facilitating facial augmentation non-surgically. It was not until four years later in 2002 when Sasaki and Cohen provided the first definitive report of malar fat pad elevation, using a variety of suture material from polypropylene, polyglactin 910, Gore-Tex and Vicryl. This work was further supported in 2002 when non-barbed suture suspensions were used with temporal fascia fixation in bringing about midface augmentation. The first description of barbed suture suspensions to be commercialized was presented in 186 patients by Sulamanidze et al when the Aptos [anti-ptosis sub-dermal suspension] was described. In 2004, Contour Threads permanent non-absorbable sutures were introduced to anchor temporal Fascia, derived once again using a polypropylene base. These barbed threads were configured in a helicoidal pattern but failed to gain momentum owing to their “permanence”.  PDO has a long safety record in surgery. In South Korea, Polydioxanone has been used for decades in orthopedics (to treat frozen shoulders, tennis elbow, golfer’s elbow, etc.) and in cosmetics for skin tightening, skin rejuvenation and face lifting indications. The popularity of PDO threads can be attributed to the safety of Polydioxanone, ease of insertion of the threads, excellent reproducible and sustainable results, minor side effects and extremely low incidence of complications. More recently in 2016 the United States, the FDA approved the use of absorbable suture suspension using PDO as an indication in lipolysis, collagen regeneration, neo-vascularization in the subcutis dermis.  

WHY USE POLYDIOXANONE [PDO] THREADS

The main advantage to polydioxanone is that it is biodegradable. This synthetic polymer is highly versatile and was originally used as a mono- or multi- filament thread.  Biodegradation of PDO occurs through a process of hydrolysis over a time period of between six to eight months. The main method of elimination is through the kidneys.  In contrast, the introduction of a poly-L lactic acid coated fine suture with bidirectional cones, was also introduced as a means of addressing issues of facial rejuvenation a number of years ago. Silhouette soft was inserted in the sub-dermal and adipose tissue.  A number of issues using this type of technology were identified; its underlying weak tensile strength, issues of repositioning the cones, an increased risk of skin puckering, cone visibility and a lack of lipolysis were limiting factors.  The principle mode of action of polydioxanone in the dermis was first thought to be solely reliant on the creation of new collagen by foreign body reaction, which promoted wound healing through tissue contraction. This traditional view failed to fully explain what was happening on a histological level.  In 2006, Howe and coworkers identified that subcutaneous tissue fibroblasts exhibited greater pleomorphism than originally postulated being responsible for cytoskeletal remodeling, and this was evidenced by a process defined as mechano transduction, where fibroblasts are able to self-sense, process & respond to mechanical stimuli in their microenviroment and importantly regulate physiological function nearby. The overall effect of this sees actin polymerization following matrix deformation by external mechanical stimuli. The polymerized actin facilitates cell contraction and activation of the mitogen activated protein kinases which in turn regulates gene expression, protein synthesis, extracellular Matrix modification, cell differentiation, and potentially promotes tissue growth. The underlying mechanisms that define the regenerative changes that take place in the dermis and subcutis from polydioxanone threads include neo-collagenesis from a foreign body reaction, microcirculation stimulation, increased metabolism, lipolysis, muscle relaxation and increased tissue adhesion. A foreign body reaction is observed together with elastic fibrosis where the thread is inserted. Studies show that increasing thread density, injecting multi-layers creates a denser framework.

SYNTHETIC BIODEGRADABLE POLYMER

The biomedical use of synthetic biodegradable polymers is believed to have begun in the late 1960’s with the FDA’s medical device approval of the first biodegradable suture. Since that time, numerous applications in the biomedical field have been made including uses such as wound enclosures, body implants, tissue engineering and most recently aesthetic enhancements. The application of these sutures accelerates micro-circulation in the treated areas. Today this technique when applied for cosmetic purposes has become known as “thread lifting”. Thread lifting has quickly been gaining popularity in the medical aesthetic industry due to its very minimal level of evasiveness and wide range of indications. It allows medical professionals to obtain many of the aesthetic benefits and results that were once only obtained through surgery. Now, many of these same treatments are available through a less invasive, non-surgical technology.

WHAT ARE THE DIFFERENT CATEGORIES OF THREADS?

The biomedical use of synthetic biodegradable polymers is believed to have begun in the late 1960’s with the FDA’s medical device approval of the first biodegradable suture. Since that time, numerous applications in the biomedical field have been made including uses such as wound enclosures, body implants, tissue engineering and most recently aesthetic enhancements. The application of these sutures accelerates micro-circulation in the treated areas. Today this technique when applied for cosmetic purposes has become known as “thread lifting”. Thread lifting has quickly been gaining popularity in the medical aesthetic industry due to its very minimal level of evasiveness and wide range of indications. It allows medical professionals to obtain many of the aesthetic benefits and results that were once only obtained through surgery. Now, many of these same treatments are available through a less invasive, non-surgical technology.

PDO

Polydioxanone (PDO) is a strong synthetic monofilament fiber consisting of one solid fiber of thread; absorbs in 6-9 months depending on thickness. PDO Threads are also known or referred to as PDS, which have been used as a cutaneous and subcutaneous suture material in plastic surgery, Cardiothoracic surgery, trauma surgery, & gynecological surgery for over thirty years.

  • Flexible, durable, last 24 months

  • Higher resilience first 2-3 months

  • Hydrophobic

  • Broken down by hydrolysis

  • PDO threads do not have antigenic or pyrogenic reactions

  • Generate neo-collagenesis in the skin

  • Mild fibrosis results which strengthen connective tissue of skin

  • Results are noticed after 4-6 weeks for mesh techniques, immediately after barbed techniques

 

PLLA Threads

Poly L Lactic Acid (PLLA) are PDO threads impregnated with Sculptra and are absorbed with 12-18 months depending on thickness.  PLLA threads provide 30% more volume than PDO threads.

PGA Threads

Polyglycolic acid (PGA) is a synthetic suture, absorbable, sterile, multifilament, which meets all requirements established by the USP. 

  • Polyfilament structure and absorption in 60-90 days. 

  • Causes pH change in treatment zone 

  • Activates pro inflammatory & pyrogenic reactions.

  • May have higher rates of redness, itching, and swelling

  • As being a synthetic suture should not be used when be necessary to support tissues for prolonged periods.

WHAT ARE THE DIFFERENT THREAD CLASSIFICATIONS FOR MIRACU PDO THREADS?

  • Mono threads are SMOOTH THREADS

  • Screw, Volume, Elasty Meshfill are VOLUME THREADS

  • Barb, Forte, Elasty Line threads are BARBED THREADS

WHAT ARE THE DIFFERENT CANULA  TIP CLASSIFICATIONS FOR MIRACU PDO THREADS?

MANUFACTURING MIRACU  PDO THREAD

FORTE PDO THREAD

ELASTY LINE PDO THREAD

ELASTY MESHFILL PDO THREAD

ELASTY MESO NEEDLE

ELASTY MICRO CANNULA

INNOVATIVE FUTURE MIRACU PDO THREADS

NOT FOR SALE AT THIS TIME. 

FORTE DOUBLE

FORTE DOUBLE HALF

LINE 2

LINE 3

MEET OUR MEDICAL ADVISORY BOARD

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Dr. Richard Goldfarb., M.D.,F.A.C.S

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Dr. Richard Jin., M.D.,PhD

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Dr. Diane Duncan., M.D.,F.A.C.S

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Dr. JD McCoy., NMP

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DBM Corporation Inc EST. 2018

23263 Madero, Suite B, Mission Viejo, CA 92612

Hours: Monday - Friday | 8:30am - 5:30pm [PST]

Phone: 949-600-7766

NOTICE

The sale of MIRACU PDO products may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. The information on this site does not, and cannot, provide medical advice and is for general informational purposes only. If you are a patient it is important to discuss health information with your doctor. Individual results may vary.

 
 

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