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 bone
fragility 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.
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Improving the treatment of Pediatric patients worldwide - About the
Fassier-Duval Telescopic IM Nail System.
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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@... www.pegamedical.com