US Clinical Trial Procedures Underway

[iSpine-Admin]

Press Release
Source: Aesculap Implant Systems, Inc.
Aesculap Implant Systems, Inc. Initiates Study of the Activ-L(TM) Artificial Disc
Monday February 12, 4:56 pm ET

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.

The first 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 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.

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 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.

Contact:

Aesculap Implant Systems, Inc.
Michael Andrews, 1-800-234-9179
Michael.Andrews@aesculap.com
Source: Aesculap Implant Systems, Inc.

[JohnnyD]

So far, so good. I was extremely fortunate to participate in this study.

Surgery at L5-S1.
Diagnosed: Degenerative Disc Disease: I had bone on bone, no material left to speak of. The discs above were beginning to bulge, perhaps a prelude to more problems.

I had surgery on July 1st at Rush University Medical Center in Chicago.
The surgeon was Dr. Harel Deutsch, a member of the neurosurgery faculty at Rush.

Thanks to the Doctor's persistence I got the Activ-L in place. Later he explained that the study comparison device, the Charite, would have been too tall for me and he would have had to resort to fusion.
I've got an approx. 5" vertical incision running down from my navel. I go Wednesday 7/16 for staple removal.

I was in hospital for 3 days total. Surgical pain was moderate. I was weaned off the morphine drip by the evening of July 2nd and went home with oral meds on the the 3rd.

Doctor didn't prescribe any formal PT, he just wants me to walk as much as possible - something I'm very happy about.

After 28 years of dealing with this condition, I feel I've got a great chance to stabilize the rest of my spine and break the cycle of pain and rehab.

Regards,
John