Aesculap Implant Systems, Inc. Initiates Study of the Activ-L(TM) Artificial Disc.AVENTURA, Fla. -- 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 Degeneration of the intervertebral disc, which is often called "degenerative disc disease" (DDD) of the spine, is a common disorder of the lower spine and for some people can cause low back pain and/or leg pain (sciatica). of the lumbar spine Lumbar spine The segment of the human spine above the pelvis that is involved in low back pain. There are five vertebrae, or bones, in the lumbar spine. Mentioned in: Low Back Pain 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. The study is being conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and and is a prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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([R])-L Total Disc Replacement and the DePuy Spine Charite([R])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 Aesculap Engineers. 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . About Aesculap Implant Systems, Inc. Aesculap was founded in 1867 in Tuttlingen, Germany and has grown into the largest and one of the most respected manufacturers of surgical instruments A surgical instrument is a specially designed tool or device for performing specific actions of carrying out desired effects during a surgery or operation, such as modifying biological tissue, or to provide access or viewing it. 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 neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system. neu·ro·sur·ger·y n. Surgery on any part of the nervous system. 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. |
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