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Mentor Worldwide launches PD Flexible Plate, a unique absorbable implant for nasal reconstruction, in US
Santa Barbara, California | Saturday, November 13, 2010, 14:00 Hrs  [IST]

Reinforcing its commitment to the aesthetic medical market, Mentor Worldwide LLC introduced PD 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 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.

“The introduction of PDS 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, MD, Gunter Centre for Aesthetics & Cosmetic Surgery, Dallas, Texas.

“PDS Flexible Plate can provide surgeons with a useful, versatile surgical option that may lead to lower incidence of suboptimal cosmetic and/or functional outcomes” he added.

Clinically Shown Effectiveness and Tolerability Multiple clinical study results found patients who underwent surgery with PDS Flexible Plate had few immediate and no long term complications and reported revision rates were low.

In multiple studies in which PDS™ Flexible Plates were used, revision rates varied from 0-4.5% (total n=482). In one study of 58 patients undergoing primary (n=37) or secondary (n=21) rhinoplasty with PDS Flexible Plate, no operative revisions were required and the PDS Flexible Plate was well tolerated by all patients with a mean postoperative follow-up of 18 months.

In another study, patients who underwent external septoplasty with PDS 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).

In a recent series of patients undergoing extracorporal septal reconstruction with PDS 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).

Versatile Tool for Complex Surgical Needs Nasal reconstruction surgeries requires a versatile surgical tool that can be adapted to meet various clinical needs. PDS Flexible Plate meets the unique demands of surgeons who perform these procedures: Absorbability – PDS 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.

Structure & Support – Clinical studies show; PDS Flexible Plate provides non-warping support during healing. PDS Flexible Plate supports the graft pieces as a guide, bridging and supporting the nasal structure and preventing overlap and bending.

Cartilage Management – Patients who have undergone multiple nasal surgeries risk graft depletion. PDS 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.

Versatile – PDS 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.

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 Flexible Plate is manufactured by Ethicon, Inc. and distributed by Mentor, a leading global supplier of aesthetic medical products.

“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.

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.

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