For most medical device companies, developing a product that will benefit patients and physicians by making a procedure more cost-effective and less invasive is a high priority. Being the first to achieve a regulatory milestone with such a device is even better. Pioneer Surgical Technology (Marquette, Michigan) believes it has done just that.

Pioneer said it has received FDA approval to proceed to an IDE pivotal study of its NuBac nucleus replacement device for the spine. The company said it is the first to receive FDA approval to start an IDE study for nucleus replacement.

"The significance to the company [and] to the spine community is that this is certainly the device the surgeon [and] patient has been looking for a long time," Chip Bao, PhD, Pioneer's VP of advanced spine, told Medical Device Daily. "Many companies have been working in this area for a long time and have not achieved this milestone."

Bao said Pioneer has spent the last few years developing a unique system. According to the company, the NuBac implant system is the only nucleus replacement device that uses an articulating inner ball and socket design that seeks to achieve load sharing and uniform stress distribution under various physiological loading conditions while minimizing extrusion risk.

"There are some inherent challenges in the development of nucleus replacement devices," Bao said. "Pioneer's unique design features of the NuBac implant have led to a series of successful pre-clinical studies and encouraging results from both the initial U.S. IDE feasibility study and post-market surveillance outside the U.S. under the CE mark."

Spinal disc arthroplasty surgery includes total disc replacement (TDR) and nucleus replacement procedures Both techniques are intended to relieve back pain caused by degenerative disc disease (DDD) and restore stability and flexibility to the affected spine segment, Bao said.

Nucleus replacement procedures have the benefit of being less invasive, he said, because they usually involve more tissue-preserving (which means more function preserving as well) and less bridge-burning than TDR surgery. The procedure also reduces the risk of having to do a revision surgery in the future, he said, but the option to do a spinal fusion procedure or TDR is still available.

TDR implants were introduced to the market in order to preserve some motion yet while the only failed area is the disk nucleus, TDR requires removing everything, significantly the annulus or outer ring of tissue. The NuBac procedure requires only an incision in annulus to remove the nucleus and then to insert the replacement device. The device received a CE mark in 2005 and the company received the green light for a full market launch last year, introducing it during EuroSpine 2007 (Medical Device Daily, Oct. 11, 2007).

"This is a huge milestone and accomplishment for Pioneer to be the first to receive FDA approval to start the IDE pivotal study for nucleus replacement. Many other companies, pursuing nucleus replacement technology, have spent more time and money than Pioneer and have not achieved this significant goal," said Chairman/CEO Matthew Songer. "This record speed to obtain FDA approval to proceed demonstrates our dedication to focused innovation and ability to bring new products to market faster than many of our competitors."

Pioneer says its signature articulating P3 technology — Pioneer PEEK-on-PEEK — is the heart of the NuBac design. The company's other P3 motion preservation products are the NuNec artificial cervical disc and the BacJac interspinous decompression system. All three products are currently available in Europe under CE mark, Pioneer noted.

Earlier this year, Pioneer reported "significant findings" on the effect of accelerated aging on the wear of PEEK (Poly-ether-ether-ketone). The study, conducted in collaboration with Rush University (Chicago), determined that wear properties of PEEK-on-PEEK are not susceptible to the effects of accelerated aging. The study bolsters support for the long-term durability of the P3 designs, according to Pioneer.

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