Interventional Spine begins clinical study for percutaneous treatment of DDD in USA


First patient in USA treated at Bergey Spine Institute, Colton, California.

Interventional Spine recently announced the successful completion of the first out-patient interventional procedure using its PDS System for the treatment of Degenerative Disc Disease (DDD) in the lumbar spine in the USA.

“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 hospitalisation, and extended rehabilitation. A very different future for DDD back pain patients was clearly demonstrated for the first time in USA, under our study protocol, thanks to the splendid work done by Darren L Bergey, at the Bergey Spine Institute in Colton, CA,” 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.

“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, 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,” he said.

“This milestone is another step forward in uniquely positioning Interventional Spine for growth in the United States. The PDS System is commercially available outside USA, under the PercuDyn System name, and our earliest patients are now beyond a three-year follow-up period with outstanding results,” said 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.”