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PDS[TM] Flexible Plate, a Unique Absorbable Implant, for Nasal Reconstruction, Now Available in the U.S.

Implant from Mentor Worldwide LLC Provides Structural Support and Streamlines Cartilage Management

SANTA BARBARA, Calif. -- Reinforcing its commitment to the aesthetic medical market, Mentor Worldwide LLC today introduced PDS([TM]) Flexible Plate - the absorbable implant that provides structural support and streamlines cartilage management during nasal reconstruction procedures.

Nasal reconstruction surgeries, such as rhinoplasty and septoplasty, can be difficult and time consuming - requiring the meticulous reconnecting of cartilage pieces to form a straight, solid plate that bridges and supports nasal structures. These procedures frequently result in disposal of valuable cartilage and complications requiring re-operation and secondary surgeries. PDS([TM]) Flexible Plate is a biodegradable polydioxanone surgical material that can act as a scaffold for the assembly of the cartilage pieces and support newly reconstructed cartilage during the critical healing period following surgery. It can also reduce the need for secondary cartilage donor site surgery.1,2,3

"The introduction of PDS([TM]) Flexible Plate will provide surgeons with a new surgical tool that delivers an absorbable, structural support they may use for nasal reconstruction," said Jack P. Gunter, M.D., Gunter Center for Aesthetics & Cosmetic Surgery, Dallas, Texas. "PDS([TM]) Flexible Plate can provide surgeons with a useful, versatile surgical option that may lead to lower incidence of suboptimal cosmetic and/or functional outcomes."

Clinically Shown Effectiveness and Tolerability

Multiple clinical study results found patients who underwent surgery with PDS([TM]) Flexible Plate had few immediate and no long term complications and reported revision rates were low. 1,2

* In multiple studies in which PDS([TM]) Flexible Plates were used, revision rates varied from 0-4.5% (total n=482).1,2,4,6

* In one study of 58 patients undergoing primary (n=37) or secondary (n=21) rhinoplasty with PDS([TM]) Flexible Plate, no operative revisions were required and the PDS([TM]) Flexible Plate was well tolerated by all patients with a mean postoperative follow-up of 18 months.1,[1]

* In another study, patients who underwent external septoplasty with PDS([TM]) Flexible Plate combined with cartilage, there were no immediate or late complications, and a postoperative straight septum was achieved in 99 percent of cases (n=71).5

* In a recent series of patients undergoing extracorporal septal reconstruction with PDS([TM]) Flexible Plate for extreme septal deviation and/or external nasal deformity, no patients developed immediate complications during the postoperative period. In addition, during follow-up of 4 to 18 months, no patients experienced subluxation or septal perforation (n=16).1,2

Versatile Tool for Complex Surgical Needs

Nasal reconstruction surgeries require a versatile surgical tool that can be adapted to meet various clinical needs. PDS([TM]) Flexible Platemeets the unique demands of surgeons who perform these procedures:

Absorbability - PDS([TM]) Flexible Plate remains intact during the critical healing process of the first 10 weeks after implantation but is absorbed completely within 25 weeks, leaving no residue and minimal fibrous scar tissue. This absorbability avoids some of the long-term problems associated with non-absorbable implants.4,5

Structure & Support - Clinical studies show PDS([TM]) Flexible Plate provides non-warping support during healing. PDS([TM]) Flexible Plate supports the graft pieces as a guide, bridging and supporting the nasal structure and preventing overlap and bending.1,4,6

Cartilage Management - Patients who have undergone multiple nasal surgeries risk graft depletion. PDS([TM]) Flexible Plate offers a highly versatile and reliable way of making maximal use of many cartilage fragments otherwise discarded, and may reduce the need for secondary cartilage donor site surgery.1

Versatile - PDS([TM]) Flexible Plate is available in a number of sizes and configurations, one of which is perforated. The product can be trimmed to suit a variety of anatomical conditions and surgical needs including rhinoplasty and septoplasty procedures, and the temporary scaffold can be used to construct columellar struts, septal extension grafts, alar battens, and upper lateral replacement grafts.1,3

Proven Track Record - PDS polymer was invented by Ethicon, Inc. a worldwide leader in surgical care, and has been used and trusted by surgeons for over 20 years. PDS([TM]) Flexible Plate is manufactured by Ethicon, Inc. and distributed by Mentor, a leading global supplier of aesthetic medical products.

Physicians can learn more about PDS([TM]) Flexible Plate at www.pdsflexibleplate.com. In the U.S., physicians can order the product by calling Mentor customer service at 1-800-235-5731. In Canada, physicians can order the product by calling 1-800-668-6069.

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1 James SE, Kelly MH. Cartilage recycling in rhinoplasty: polydioxanone foil as an absorbable biomechanical scaffold. Plast and Reconstr Surg. 2008;122:254-260. 2 Boenisch M, Tamas H Noist Trenite GJ. Reconstruction of the Nasal Septum using Polydioxanone Plate. Arch Facial Plast Surg 2010;12:5-9 3 Data on File, Ethicon, Inc. Clinical Expert Reports-PDS Plates 2009 ([1]) Petropoulos I, Nolst Trenite G, Boenisch M, Nousios G, Kontzoglou G. External septal reconstruction with the use of polydioxanone foil: our experience. Eur Arch Otorhinolaryngol. 2006;263:1105-1108. 4 Boenisch M, Tamas H, Nolst Trenite GJ. Influence of polydioxanone foil on growing septal cartilage after surgery in an animal model. Arch Facial Plast Surg. 2003;5:316-319.

Mentor Expands into the Facial Surgical Aesthetics Market

PDS([TM]) Flexible Plate is the first surgical facial aesthetics product offering from Mentor.

"Mentor's partnership with Ethicon, Inc. further enhances our ability to provide surgeons and patients with the trusted, clinically proven products that they have come to expect from both companies," said Martin Weisberg, M.D., Director of Medical Affairs, Ethicon, Inc.

Dr. Gunter is compensated for his time as an advisor to Mentor.

About Mentor Worldwide LLC

Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to retain a more youthful appearance and improve their quality of life. For more information about Mentor, visit www.mentorwwllc.com
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Publication:Business Wire
Geographic Code:1U9CA
Date:Nov 11, 2010
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