ViaCell (Cambridge, Massachusetts), focused on enabling the widespread use of human cells as medicine, said that the FDA has conditionally approved its investigational device exemption to evaluate its ViaCyte investigational product offering for the cryopreservation and thawing of human oocytes for use during assisted reproductive procedures. The company said it intends to conduct a single, pivotal clinical trial to study the safety and efficacy of ViaCyte. The open-label study will be conducted at multiple sites in the U.S., Spain and Argentina. Enrollment is expected to begin in late 2006. If the results of the study are positive, ViaCell expects to seek marketing clearance under the FDA's 510(k) pathway. There is currently no FDA-cleared product for oocyte cryopreservation.

Zimmer Dental (Warsaw, Indiana), a provider of dental rehabilitation products and a subsidiary of Zimmer Holdings, reported the U.S. availability of the new Atlantis Abutment in Zirconia. The company said the introduction of this all-zirconia internal connection abutment raises the standards for ceramic technology and enables it to offer a more complete implant prosthetic system. The Atlantis Abutment in Zirconia is compatible with Zimmer Dental's Tapered Screw Vent implant system. Designed with the Atlantis expert system-based design process so that no additional modification prior to placement is necessary, the company said this engineered abutment with an internal connection is the first all-zirconia, patient-specific abutment available to clinicians in the U.S.

No Comments