BRUSSELS — “They have us surrounded,” shouted a product manager at Stryker EMEA (Montreux, Switzerland), looking across the aisle at the stand for Kyphon Europe (Zaventem, Belgium) and then turning around to look up at the looming monolith in the Medtronic (Minneapolis) display area of Medtronic (Minneapolis) (which has agreed to purchase Kyphon.

The event: last week’s EuroSpine 2007 conference, with Stryker featuring two new product introductions — Xvoid, which aims at a head-on assault, challenging Kyphon’s monopoly for spinal kyphoplasty, and Solis RS, which Stryker said is the world’s first bioabsorbable, radio-marked cervical cage.

To treat a fracture or compression fracture in the spine, the pedicle is punctured and reamed. The “void” is created using an x-shaped expander tool so a needle can inject PMMA (polymethylmethacrylate) cement to repair the fracture.

Stryker has added more barium to the cement to aid with video fluroscopy guidance, and the nitinol alloy expander tip is radio-opaque.

“The EU market is massive at $100 million,” said one Stryker manager, who described the battlefield.

“We have 100 reps versus 60 for Kyphon, but we are seen as hip-and-knee people, not spine specialists. Meanwhile Kyphon has the advantage of being first to market, with a three-year lead. Now they have Medtronic behind them, so the game has changed. The question is how important Kyphon’s business is for Medtronic. Personally I believe $100 million is probably important.”

Pat Beyer, president for Europe, Middle East and Africa (EMEA) for Stryker (Kalamazoo, Michigan), rallied the troops, saying, “The market space in kyphoplasty is big enough for two players, and it will be important for the surgical community to have a choice.”

The new Solis RS bioresorbable cage for cervical interbody fusion took the Stryker development team in Montreaux just 18 months to bring to market, according to Bill Chambers, spine franchise manager for EMEA.

The CE mark was received in April and “soft” showings of Solis RS were offered in Germany in May and in the UK in September. EuroSpine was the scene of the product launch for the full market.

“The EMEA market for cervical cages is between $30 million and $40 million,” he said, and “we are exceeding targets, especially in Germany, and are enjoying an incredible uptake in South Africa.”

Made of poly-L-lactic acid (PLLA), a biocompatible, biodegradable and immunologically inert synthetic polymer, Solis RS is a translucent ring with three thin embedded rods made of barium sulphate, a radio-opaque substance.

Typically for cervical cages, a bone plug is extracted from another part of the patient is fitted into the ring, but this caused more post-operative pain than the spine procedure, he said.

Stryker proposes a cage insert with Solis RS called Tribone 80, a macroporous, biocompatible ceramic.

The market challenge, said Chambers, will be “a heavy education and communication focus to reinforce the science behind the product. There was bad press for past failures by other companies over issues of consistency in degradation, the tendency of their cages to fail early, and that surgeons could not image the device during placement.”

— John Brosky