When a U.S. patient is told they need a fusion lumbar surgery for degenerative disc disease (DDD) it usually means they are facing an open surgery with complication rates as high as 20%, four hours under general anesthesia, a four- to six-inch incision across all the primary muscle groups in the back, two or three days in the hospital, and post-operative rehabilitation, according to Dennis Sellke, senior VP of market development & marketing for Interventional Spine (Irvine, California).
By contrast, a product from Interventional Spine, the PDS System, currently being used in an investigational device exemption trial in the U.S., offers a less-invasive solution, Sellke told Medical Device Daily.
The company said this week it has completed the first U.S. outpatient interventional procedure using its Percutaneous Dynamic Stabilization (PDS) System for the treatment of DDD in the lumbar spine. This milestone marks the initiation of a clinical study under an IDE protocol approved by FDA in late November 2008, Interventional Spine noted.
"It's an IDE trial so [we have a] long way to go before we get a U.S. approval," Sellke said. He added that the first case was done in an outpatient setting, the patient left the hospital that day and based on the report Monday morning is feeling fine and looking forward to no rehab or limited rehab.
"The interesting thing is it's a huge business; there is a $4.5 billion industry based on a surgical premise that may not be the standard of care five years from now," Sellke said, adding that Interventional Spine sees its PDS System as a "game-changing" technology.
"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 U.S.," said CEO Walter Cuevas. "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."
Cuevas said that Darren Bergey, MD, performed the procedure at the Bergey Spine Institute (Colton, California).
"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 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 outpatient 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."
The company expects to complete the trial by June 2010 and will enroll about 290 patients double-blinded with fusion in a two-to-one ratio.
Because the PDS System offers, according to the company, equal to or better outcomes than the typical approach at a significantly lower cost, Sellke said the product offers the "perfect storm" in the U.S., especially given the current economic climate and the direction that the healthcare system is headed.
Sellke noted that there are two other products available now that approach the "right idea," one being the X-Stop Spacer from Medtronic (Minneapolis) and the other is the Coflex from Paradigm Spine (Wurmlingen, Germany). However, both of those devices use the spinous processes and require a larger incision to insert the device in. He also noted that about 20% of the population cannot benefit from either of those devices.
"Our device is a bilateral device which is put into the bone in the pedicel of the spine and . . . we can deal with 100% of the patient population, they can only deal with 70% or 80%," Sellke said.
According to Medtronic, the X-Stop Spacer is a small implant that fits between two bones – the spinous processes – in the back of the patient's spine at the level of the pinched nerve. Once in place, the X-Stop Spacer is designed to stay safely and permanently in place without being attached to bone or ligaments, by screws or other hardware, and there is no fusion involved, Medtronic says. It works with the patient's spinal anatomy to keep the space around the nerve open even when the patient stands up straight and walks. Like the PDS System, the X-Stop Spacer is implanted during an outpatient procedure under local anesthesia.
Sellke told MDD he has been in the device industry for a "long, long time" and "we've all seen good technology" be released on the market that only a fraction of the clinicians can really deploy because of skill or other limitations. "This technology is so simple to use that anybody can learn the skill set to do it well so you're not going to have a limitation," he said.
Cuevas noted that the PDS System is available outside the U.S. under the PercuDyn System name and the company's earliest patients are now beyond a three-year follow-up period with "outstanding results."
Sellke said that because of the way medicine is practiced in Europe the PercuDyn System doesn't typically move to an outpatient setting, however it is done as a less invasive procedure.
Interventional Spine is a private company that develops implantable devices for the spine that can be deployed via percutaneous techniques.