GENEVA, Switzerland — The long dance between the non-profit AO Foundation and spinal implant maker Synthes (Solothurn, Switzerland/ West Chester, Pennsylvania) is coming to an end, but AO Spine, which provides research and education for spine surgeons worldwide, still has a five-year high-wire act ahead as it balances its mission of independent training with the commitments it has made to Synthes.
By 2004 Synthes, which was created to bring to the American market the Swiss-built spine products of two companies behind the Arbeitsgemeinschaft für Osteosynthesefragen (AO), had progressively acquired the other two companies supporting the foundation.
To straighten out the complicated patent arrangements with AO, Synthes announced that it would purchase all of the foundation's intellectual property touching its spine products with a lump sum payment of 1 billion Swiss francs, or $770 million at that time.
The German Federal Cartel Office (FCO) immediately challenged the purchase agreement, saying a side agreement linked to the purchase, where AO Spine would continue its collaboration in surgeon training and education, constituted an unfair competitive advantage.
In August 2006 the FCO cleared the way for the patent purchase to go forward, but, saying it was not satisfied with the related collaboration, forced the parties to agree to address these concerns in the coming months.
Months became years of negotiations and according to the director for AO Spine in Europe, Neill van der Linde, the two parties have reached an agreement that will satisfy the concerns of the FOC.
"There is some last-minute fine-tuning," he told Medical Device Daily, "but the agreement will be signed in the course of this year."
The main point of the agreement, he said, is that AO Spine maintains full academic freedom for events, publications and research but commits to exclusive use of Synthes products for technical workshops.
"The agreement with Synthes limits us to closely defined in-scope and out-of-scope exclusivity for the next five years," van der Linde said.
Out-of-scope is anything that Synthes does not manufacture.
"Just because Synthes submits a product does not mean it is adopted for a technical workshop," he said.
"First, we are not bound to organize a given practical workshop. And second, the product needs to be endorsed by the AO Technical Commission to be used in a practical workshop, and this is a review by surgeons," said van der Linde.
For surgeons throughout the world, AO Spine's seminars, training and workshops play an essential role in continuing education.
"We fit somewhere between the regional spine societies that have limited means to provide continuous and consistent education, and on the other side the education provided by industry with zero-to-little academic credibility," he said.
Half of AO Spine's annual budget comes from interest on the generous endowment of the foundation and the remainder from sponsorships, membership fees, publications and training.
AO Spine also has a service agreement with Synthes where it is paid to to provide a fixed number of educational events per year worldwide as well as product consulting and certification services.
In other SpineWeek news:
• A gimmick designed to draw participants into the exhibition stand of Abbott Spine (Austin, Texas) was presented as a prototype for surgical training and education.
At the October 2007 meeting of the North American Spine Society in Austin, Abbott set up a surgery simulator with the goal of provoking a competitive spirit among surgeons to improve scores for 11 parameters including procedure time, fluoroscopy exposure and screw placement.
The success of the simulator at the event encouraged Abbott to build a more serious trainer for pedicle screw placement that was introduced at SpineWeek as a prototype for medical schools and surgeon certification.
Ken Walker, senior medical education manager for Abbott, said the system was redesigned as a true representation of spinal surgery using CT-acquired images instead of the CAD drawing featured on the first version and changing the scoring parameters to reflect real-world conditions.
He said Abbot is conducting validation studies throughout the summer to build the credibility of the simulator.
"There is a value for more than just medical students," said Walker. "This teaches surgeons to do better the same procedures they have been doing while reducing the interoperative radiation and achieving better pedicle screw placement."
"We have not even named this prototype," he said.
• Medtronic's (Minneapolis) strategic integration plan to integrate the products and operations of Kyphon (Sunnyvale, California) that it acquired last fall (Medical Device Daily, Nov. 7, 2007) was on public display at SpineWeek.
The companies set up separate exhibition stands, but employees wore a path in the carpet running back and forth throughout the event, chasing executives of both companies for demonstrations and customer meetings or leading surgeons from one product display to another.
The Spinal and Biologics business of Medtronic, based in Memphis, Tennessee, announced at SpineWeek it will introduce in Europe two components of its Minimal Access Spinal Technologies portfolio that were launched in the U.S. last September.
The CD Horizon Longitude System, available in Europe this coming September, is a multi-level, percutaneous spinal-fixation system that can be used in all curvatures of the spine to treat pathologies such as trauma, tumor, degenerative disc disease, and deformity.
The CD Horizon Legacy PEEK Rod System, to be available in June, is a posterior semi-rigid stabilization implant offers a slight flexibility for spinal stabilization that is expected to reduce stress at the bone-to-screw interface experienced with more rigid systems.