BRUSSELS — The opportunity in a Europe-wide surgical event is to see dozens of CE-marked products a number of years before FDA approvals and an introduction to the U.S. market.

On one hand, a European industry event becomes an off-Broadway venue for U.S. companies who come here to prepare for the big box office rewards that a winning performance can earn back in the vast and unified U.S. market.

On the other hand, the European market itself is a serious business opportunity that can be as rewarding for sales revenue as it is challenging for overcoming the fragmented distribution and reimbursement structures of the European Union.

More and more Europe serves as a reminder of how off-Broadway box offices cast a considerable shadow over those of the Great White Way.

What drew the crowds at EuroSpine 2007, held here last week, were products playing to the emerging surgical preferences for the patient-friendly and cost-effective qualities of “minimally invasive” and “preserving motion.”

Meanwhile, bioabsorbable materials have not yet come to center stage for spinal implants, although the number of presentations on these themes and the increase in product development for such qualities promise that bio-friendly will play a greater role in the near future.

Pat Beyer, president for Europe, Middle East and Africa (EMEA) for Stryker (Kalamazoo, Michigan), told Medical Device Daily, “After the minimally invasive products, I am seeing a lot of reference to morphogenic proteins and note that generally more biologics are hitting the market for spine at the show this year.”

Among orthopedic surgeries, the spine remains a special area, and surgical practices have been staunch holdouts against certain product innovations, notably in the trend toward nearly natural flexibility and movement for implants and prosthetics brought on by the introduction of new materials that have captured a significant share of new products introduced for other surgeries.

“Over the past 15 years, hip and knee surgeons have developed protheses to preserve movement,” noted Christine Coillard, MD, a pediatric surgeon at the Centre Hospitalier Universitaire Sainte-Justine at the University of Montreal.

“Yet in spine we are late, very late in changing, and even today we continue to fuse, and only to fuse, the vertebrae,” she said.

Coillard was attending EuroSpine for the introduction of a novel surgical approach to treat adolescent idiopathic scoliosis in a way that “not only allows growth, it even grows with the patient.”

Meanwhile, Chip Bao, VP of spine development for Pioneer Surgical Technology (Marquette, Michigan), already has let go of the past, saying bluntly, “Fusion was yesterday; tomorrow is motion persistence.”

Bao was on hand to explain the science behind what his company promoted as a first posterior disc arthroplasty system.

A surprise introduction at a EuroSpine luncheon was a new concept for interspinous distraction from Synthes (Solothurn, Switzerland).

A percutaneous approach to treat lumbar stenosis and neurogenic intermittent claudication, Synthes In-Space requires a 1.5 cm incision, for the insertion of a series of tools that use blunt dilation rather than cutting to get past spine muscles and position the implant. To position the insertion sleeve that will guide the implant for placement between the vertebrae, the intra-spinous ligament is pierced but significantly, the supra-spinous ligament is not touched.

Procedure time is half of the 40 minutes needed for the implant of a device through traditional surgical techniques.

At Scient’x (Guyancourt, France), “the story is big growth and gaining market share on our competitors,” according to Anne Renaus, responsible for both those areas as VP of marketing and business development.

“In 2002 we were at €10 million ($14.1 million) and we will pass €32 million ($45 million) this year,” she said, adding, “Millenium Research Group ranks us as fifth for market share in Europe, so we are now ahead of Zimmer.”

Ahead of Scient’x in the ranking for market share in Europe in ascending order are Stryker EMEA (Montreux, Switzerland), Synthes, DePuy Spine (Raynham, Massachusetts) and Medtronic (Minneapolis).

At EuroSpine, Scient’x launched five new products, available only in the European market.

Two products aim “to complete our products portfolio,” Renaus said.

Lyra is a new plate for thoracic and thoraco-lumbar instabilities, and Isobar TTC offer implants for occipito-cervical spinal osteosynthesis.