New telescopic system for treatment of bone deformities
cleared by US-FDA and Canadian-TPD
October 1st, 2004 - Montreal, Canada – Pega Medical announces that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) and an Amendment to its licence from the Canadian Therapeutic Product Directorate to market its new LON and SPS series of implants to complete its full line of the Fassier-Duval Telescopic IM Nail System. This novel device, used for the surgical treatment of bone deformities and fractures in patients suffering from Osteogenesis Imperfecta (OI), limb length discrepancy (LLD) and other bone deformities, now offers the surgeon a full range of options for the treatment of lower and upper extremeties.
New Indications
Besides OI the new implants completing the Fassier-Duval line will facilitate its use in Lengthening Over Nail, as well as treatment of Tibial Pseudoarthrosis. OI is a genetic disorder whereby the body of the affected patient either does not produce enough collagen or produces collagen of a poor quality, resulting in extreme bonfragility or what is known as brittle bones, i.e.: bones that fracture repeatedly and easily. For example, a child with severe OI could fracture a leg whilst turning in their sleep. Various treatments exist, including drugs, to aid the production of bone mass, and surgery to help straighten bones and prevent fractures. Bone lengthening and reconstruction procedures are commonly used in cases of Leg Length Differences; Arm Length Differences; Birth Defects (Congenital Deformities); Posttraumatic Bone Deformities; Non- Healing Fractures (Nonunions); Bone Loss From Tumor, Trauma, or Infection; Congenital Pseudarthrosis; Achondroplasia and Other Skeletal Dysplasias; etc.
Improving the treatment of Pediatric patients worldwide - About the Fassier-Duval Telescopic IM Nail System. The Fassier-Duval Telescopic IM Nail System is an endomedular device aiding patients living with OI. Unlike other commercially available rods, the telescoping range of the F-D system has been increased as has the stability and fixation of the rod, reducing the necessity of revision surgery. The rehabilitation time post-op is reduced compared to that of other systems due to a minimally invasive technique and because the articular joints are unaffected by the surgery. Both reoperation and complication rates at 4 years has been reduced by 3- fold when compared to competitive devices. Initially developed by a bio-engineering company (Pega Medical Inc.) and Drs. Francois Fassier (Montreal Shriners Hospital) and Pierre Duval (BMP Hospital) as an alternative telescopic rodding system for surgical treatment of OI, the system has now extended its line of components by incorporating ideas and principles of Dr. Dror Paley (Rubin Institute, Baltimore) to improve the outcome for patients requiring bone lengthening procedures.
The technique of lengthening over nails (LON) was developed in Maryland in 1990. The rationale behind this method is to reduce external fixation time. At the time of surgery, the intramedullary nail (metal rod) is inserted into the central hollow part of the bone. An external fixator is also applied to the bone. The lengthening is performed with the external fixator, and the F-D telescopic nail expands as distraction osteogenesis occurs. The external fixator is needed to perform the actual lengthening. Once the length is achieved, the external fixator can be removed in the operating room. The full consolidation of the distraction gap proceeds under the protection of the rod since it also prevents any bending, breaking after removal of the external fixator. Growth of the pediatric patient continues normally as the telescopic rod follows the bones natural growth. The external fixation treatment time is reduced by approximately one-half to two-thirds of what it would be if no nail were used. Using the nail also avoids the need for a cast or a brace after removal. A comparison between the LON method and the Ilizarov method showed that the recovery rate of knee motion after LON was 2.2 times faster than after the Ilizarov method. Over 300 implants have been used to date to treat patients across US, Canada, Spain, Belgium, Kuwait, Peru, Ecuador, and Slovenia.
About Pega Medical
Pega Medical is an ISO 13485-certified privately held company based in Montreal specializing in the design, development, evaluation and manufacturing of orthopaedic medical devices. The company plans to launch the additional components into the world market in Q.1 of 2005.
For further information: Ariel Dujovne, President, Pega Medical Inc. 9260 Viau blvd., Montreal, Quebec, CANADA Tel: (514) 322 8560 Fax (514) 328 9548 adujovne@pegamedical.com, www.pegamedical.com
