Interventional Spine Announces The Initiation Of Its U.S. Clinical Study For Percutaneous Treatment Of Degenerative Disc Disease

Main Category: Bones / Orthopaedics
Also Included In: Back Pain
Article Date: 22 Apr 2009 - 1:00 PDT

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Interventional Spine, Inc. announced the successful completion of the first U.S. out-patient interventional procedure using its PDS System for the treatment of Degenerative Disc Disease (DDD) in the lumbar spine. This milestone marks the initiation of a clinical study pursuant to an Investigational Device Exemption protocol approved by the U.S. Food and Drug Administration in late November 2008.

"Our goal for this study is to prove the safety and effectiveness of the PDS System as an alternative in the treatment of chronic back pain related to DDD for many of the 400,000 patients annually facing open fusion lumbar surgery in the United States," said Walter A. Cuevas, Interventional Spine's CEO. "Presently, most fusion surgeries still require large open incisions across the primary muscle groups in the back, multi-day hospitalization, and extended rehabilitation. A very different future for DDD back pain patients was clearly demonstrated for the first time in the U.S. under our study protocol, thanks to the splendid work done by Dr. Darren L. Bergey, at the Bergey Spine Institute in Colton, CA," Mr. Cuevas continued.

"The ability to offer our patients less invasive procedures to treat their back pain with clinical outcomes equal to or better than we see in open fusion surgery is what we are all about at the Bergey Spine Institute," said Dr. Bergey, an orthopedic spine surgeon. "This objective provided the impetus to my participation as an investigator in Interventional Spine's study. The study's first patient was a 62 year old male. We performed a percutaneous two-level (L-4 to S-1) PDS System procedure in our state of the art out-patient surgery facility, and sent him home today sitting in the front seat of his own car. Our expectation is for this patient to be able to return to a normal, pain free life in just a matter of days," Dr. Bergey concluded.

"We are delighted to begin this study and expect patient enrollment to accelerate at a number of clinical sites over the next few weeks. We thank Dr. Bergey and his team and wish his patient the very best outcome possible. This milestone is another step forward in uniquely positioning Interventional Spine for growth in the United States. The PDS System is commercially available outside the U.S. under the PercuDyn™ System name, and our earliest patients are now beyond a three-year follow-up period with outstanding results," commented Mr. Cuevas, who added, "Detailed information on the PercuDyn™ System will be presented at the upcoming SAS '09 Meeting in London at the end of this month."

Information regarding the U.S. study may be found online at http://www.ClinicalTrials.gov, under: PDS vs. Fusion for Treating Degenerative Disc Disease, and at the Company's website, http://www.i-spineinc.com.

Source
Interventional Spine, Inc.