Medical Device Daily Contributing Writer
and Staff Reports

Five adult patients at the Centre Hospitalier Universitaire (CHU; Limoges, France) are scheduled this year to receive a next-generation ceramic implant modeled on digital imagery from the university hospital linked to a computer-assisted laser in a nearby research center.

This city, famous for its exquisite porcelain, is reinventing itself as a center for high-grade ceramics, including large-scale bone-like china for the skull. The next surgery is scheduled for March, with one each month following.

The sophistication of the hydroxyapatite mixture for creating the ceramic refined by selective laser sintering, and the precision of the stereolithographic modeling, creates an alternative for cranio-facial surgeries to both bone grafts and even to resin-based implants also fabricated by stereolithographic modeling.

Density and porosity of the Limoges ceramic implant is built up in layers of 100 microns enabling creation of complex structures, such as a brow where hard surfaces mix with porous areas meant to encourage bone growth. Structures for osteoconduction in the implant can be specified by the surgeon.

While autogenous bone graft is an accepted standard for craniofacial procedures, limitations have spurred a search for a substitute. Associated complications with bone grafts include donor site morbidity, increased operative time, blood loss and additional costs, such as extended hospital stays. There also is a limit to the quantity of graft tissue that can be harvested from one part of the patient’s body for another part.

In December the French government awarded €200,000 to finance 15 more surgeries by Jo l Brie, MD, who performed the first operation with the high-performance prosthesis in January, 2005. The French agency for health safety, AFSSAPS (Agence fran aise de s curit sanitaire des produits de sant ) approved the use of the new ceramics in September 2004.

Brie presented results on the first four surgeries last September at the annual meeting of the International Brain Mapping & Intraoperative Surgical Planning Society (IBMISPS).

The implant shaped for each patient responds within a tenth of a millimeter the missing segment,” said Brie. “This guarantees a better match to the morphology of the patient, a particular advantage where the bone loss is complex or of a significant size.”

The placement of the implant greatly reduces complications such as infection, hemorrhage, or fractures, which can accompany the removal of bone graft tissue, Brie said.

Continuous post-operative irrigation of the implant is not required, as is the case for biological cements, and the ceramic implant does not give off any residual monomer content that can provoke biological intolerance.

“The first two implants had imperfections but I was able to shape them to fit,” said Brie. “For the last two surgeries the implants were a perfect fit.”

Compared to bone graft procedures, which he acknowledges do not produce a pleasing result over large surfaces, patient hospital stays are significantly reduced with the ceramic implants. “A bone graft patient stays eight days and is still limping after 15 days,” Brie said. “My recent patients were up and walking after two days.”

“But I just do the hand work,” he said, crediting the nearby Ceramic Technology Center (CTTC) for the design and fabrication of the implants. The center has eight international patents pending for the techniques and materials.

Christophe Chaput, director of the CTTC, said that since the Jan. 17 announcement of surgical successes the center has begun receiving inquiries and orders for implants. A surgeon in Toulouse has asked for an implant 10 cm by 20 cm, “a significantly large piece.”

“We are still in a phase of clinical study,” Chaput said, adding that an affiliate of the center, Cerampelot (also Limoges), has been created for the marketing and commercial applications of the implants.

Brie said that considering the uptake in France, where an estimated 200 cranioplasties are performed each year, he would like to see the ceramic implants approved for market ahead of 2009, the year he estimated results will be complete from the 19 surgeries planned.

“This is replacing bone with a dry bone,” he said, noting that hydroxyapatite is the same composition as bone minerals. For large cranial surfaces, “there just is not an alternative that is made so exactly that is as compatible with the bone.

“The challenge right now is to master the porosity specified for the piece,” he said. The digital process of the stereolithographic allows a precision in pore placement and in designing structures that are either unidirectionsal or bi-directional.

The frontal constructive surgery for the Toulouse patient is scheduled for July and the design of the piece will include porous zones to lighten the weight of the 10 cm by 20 cm construction, as well as a porosity designed to encourage growth at specific interfaces between the bone and the implant.

The CTTC research for applying a stereolithographic process to ceramics received €1.3 million in 2001 from the European Commission under the Fifth Framework Program and the regional department of Haute-Vienne.

B. Braun unit chooses TrackWise

Sparta Systems (Holmdel, New Jersey), a provider of enterprise quality and compliance process management software, said that B. Braun Medical AG Switzerland, (Sempach, Switzerland), a subsidiary of B. Braun Group, has selected Sparta’s TrackWise product as its quality management and compliance system.

TrackWise is a web-based tracking software tool for electronically managing, tracking and trending quality, regulatory and organizational compliance processes and action items. It meets electronic record and signature requirements of Europe and the U.S.

B. Braun Medical AG will implement TrackWise to integrate and manage internal quality and environmental health and safety processes, including deviations, batch usage decisions, investigations, events, corrective and preventive actions, change control, action items, effectiveness checks, internal audits and observations, and supplier audits and observations.

The system will be utilized by B. Braun Medical AG’s headquarters location in Sempach and its four other manufacturing, service and warehouse locations in Switzerland.

Sparta Systems’ subsidiary, Sparta Systems Europe, will work with B. Braun Medical AG throughout the TrackWise planning, implementation, and deployment phases.

B. Braun Medical AG has five locations and more than 750 employees in Switzerland. It is responsible for the production of disinfection and hygienic products, infusion accessories, solutions and volume replacement, and the reprocessing of sterile supplies.