AVENTURA, Fla.--(BUSINESS WIRE)--Aesculap Implant Systems,
Inc. is pleased to announce that Dr. Rolando Garcia, Jr. of Aventura
Hospital and Medical Center, has performed the first implants of
the Activ-L Artificial Disc. The Activ-L Artificial Disc is being
investigated for the treatment of single-level degenerative disc
disease of the lumbar spine that has been unresponsive to prior
conservative treatment of at least six months duration. The design
incorporates a center core intended to allow both translation and
rotation and to more closely approximate physiological motion.
|Source: Aesculap Implant
implants of the Aesculap Implant
Systems Activ-L Artificial Disc were
performed at Aventura Hospital and
Medical Center by Dr. Rolando Garcia,
Jr. (Graphic: Business Wire).
The study is being conducted under an Investigational Device
Exemption and is a prospective, randomized, single-masked, controlled,
multi-center clinical trial consisting of an estimated 387 subjects.
In the study, the Activ-L Artificial Disc is being compared with
the Synthes Spine ProDisc®-L Total Disc Replacement and the
DePuy Spine Charite® Artificial Disc. Between 15 and 20 investigational
sites will participate in the investigation.
Dr. Rolando Garcia, Jr. and Dr. James Yue
of Yale worked on the development of the
Activ-L Artificial Disc in conjunction with
The Activ-L Artificial Disc received the
European CE Mark in 2005. Currently, the
Activ-L Artificial Disc is in clinical use
in Europe and Canada. The Activ-L currently
is limited to investigational use only in
the United States.
About Aesculap Implant Systems,
Aesculap was founded in 1867 in Tuttlingen,
Germany and has grown into the largest and
one of the most respected manufacturers of
surgical instruments in the world. Over the
years, Aesculap has continued to evolve into
a diversified healthcare corporation by focusing
its expertise in the areas of orthopaedics,
spinal implants, neurosurgery and vascular
systems and sutures.
In order to be more responsive to its growing
customer base in spine and orthopaedics,
Aesculap, Inc. formed a new company, Aesculap
Implant Systems, Inc. This new company will
focus on these unique markets allowing for
greater innovation and customer service.
Aesculap Implant Systems maintains a surgeon/patient
focus with the goal of improved operative
procedures and patient outcomes leading to
an improved quality of life.