BRUSSELS, Belgium — Ben Murdock, director of product management for Kyphon Europe (Zaventem, Belgium), has a concise view of the state of the market his company is addressing.

“The general trend,” he said, “is to do less sooner, to treat with simple percutaneous procedures that are less invasive but deliver the symptom relief and patient satisfaction.”

With that trend firmly in mind, Kyphon Europe’s booth at last week’s EuroSpine 2007 conference here featured the Aperius approach to degenerative lumbar spinal stenosis.

St. Francis Medical Technologies (Alameda, California) put the first device on the market, said Murdock, with a nod to Kyphon’s (Sunnyvale, California) recent acquisition of the developer of the X-Stop device and procedure.

Requiring a 3 cm incision mid-line, resecting both sides of the spinal column, the X-Stop procedure takes 30 to 45 minutes and “is not a major invasive procedure,” he said.

Kyphon’s Aperius is a next-generation evolution with a 1.5 cm unilateral posterior approach for the percutaneous insertion of an implant to the inter-spinous space to relieve the symptoms.

The treatment is indicated for stenosis at a mild-to-moderate stage, “a significant population and there are 15 different competitors’ products offered for similar indications,” Murdock said.

“Stand-alone is the key feature for the market we are going after,” he said. “The surgeon is only placing one device and the patient satisfaction and the pain relief is based solely on that device.”

Pioneer Surgical Technology (Marquette, Michigan) promoted the world premiere for Nubac at EuroSpine, a less-invasive procedure that reinvents disc arthroplasty, according to Dr. Lex Giltaij, VP for Europe and business development.

Chip Bao, VP of spine development for the company, said Nubac is a novel approach that is more sparing of tissues than total disc replacement procedures and does not burn bridges because it can be removed and replaced, as opposed to total fusion, “from which there is no return, a last resort.”

Total disk arthroplasty (TDA) implants were introduced to the market in order to preserve some motion, said Giltaij, “yet the clinical problem is that while the only failed area is the disk nucleus, TDA requires removing everything, significantly the annulus or outer ring of tissue.”

He said the Nubac placement procedure requires only an incision in annulus to remove the nucleus and then to insert the replacement device.

The plastic device, two PEEK plates seated on a convex-concave ball joint, is nested in the cavity with the original annulus surrounding it. The placement is secured by the natural pressure of the spinal column. The patient’s movements and the local anatomy promotes an organic process of settling the implant within the space, he said.

Nubac received a CE mark in 2005 and “now we have the green light for a full launch and market introduction at this event,” Giltaij said, and he estimated the worldwide market for fixation systems for degenerative spine at $1.2 billion annually.

Nubac is CE-marked as disk arthroplasty, allowing it to qualify for reimbursement in most markets.

Giltaij said Pioneer has entered investigative device exemption (IDE) clinical study in the U.S, with final FDA approval seen as four to five years out.

“Our market challenge is to first be understood as a patient-friendly alternative to total disk arthorplasty, but then to move to a position of being seen as the first treatment option and push the existing tier one procedures to the alternative position.”

Paradigm Spine (Wurmlingen, Germany) had a “soft” showing for four products at the Spinal Arthroplasty Society meeting in Berlin in May and launched that group for the full EU market at EuroSpine.

The larger-volume but lower-innovation launch was for modification to the company’s main Coflex platform. Three products shown in Brussels fit into the Coflex line.

Coflex-F is an upgrade that provides tools for a minimally invasive lumbar fusion without screws and therefore with less effort.

Also being presented in physician forums, but not displayed on the exhibition floor, was DCI, a cervical dynamic stabilization — a hybrid system combining a disk cage and prosthesis, “a simpler but dynamic offering for slow fusion,” according to the company.

Brand new at Eurospine was DSS for lumbar dynamic stabilization. Used in combination with the Paradigm rod system, DSS facilitates a defined movement and is adjustable to a defined range of motion that imitates a natural range.

Paradigm Spine’s second core platform is built around the Orthobiom technology, a non-fusion alternative designed to preserve the motion and corrective growth of a deformed spine for a child affected by pediatric scoliosis. The tools and technique were developed by Drs. Charles Rivard and Christine Coillard at Sainte-Justine in Montreal over the past 14 years.

“This is a new way of thinking in allowing growth while correcting deformity and without re-operation,” Coillard said.

The spinal deformation begins with growth for adolescents between 9 and 13 years old, she said, and the patient will require from two to four subsequent operations to continue adjustments to their growth.

The Orthobiom non-fusion scoliosis procedure permits a persistent micro-movement so the deformation caused by growth is continually corrected, “and then at the age of 19 or 20 years this device can be removed,” she said.

The 510(k) pre-market application is now before the FDA after completion of IDE clinical testing begun in 2000.

“This is a revolutionary product,” said Rivard. “We are feeling very encouraged by the growing understanding among surgeons of the importance of non-fusion, but our past experiences have taught that us we need to go slowly, and also we will need surgeons with a high skill level who frequently perform such surgeries.

And Rivard suggested that the company is in the happy position of not having to pursue standard commercialization.

“I would rather say that we have begun a process of choosing our customers,” he said.