B2A peptide-coated ceramic granules, with encouraging results in pilot studies of transforaminal lumbar interbody fusion, were here reformulated into Amplex with a coating concentration of 225 μg B2A/cm (3) ceramic granules (B2A-granule) with the goal of eliminating autogenous bone graft in foot and ankle arthrodesis.

B2A peptide-coated ceramic granules, with encouraging results in pilot studies of transforaminal lumbar interbody fusion, were here reformulated into Amplex with a coating concentration of 225 μg B2A/cm3 ceramic granules (B2A-granule) with the goal of eliminating autogenous bone graft in foot and ankle arthrodesis.

AMPLEX, B2A Enhanced Ceramic Granules (AMPLEX), is the Investigational Device supplied in kit form and must be used as a system. When fully prepared according to the IFU, AMPLEX consists of osteoconductive granules (BVF) with bound synthetic B2A peptide. The AMPLEX kit contains two sterile, non-pyrogenic components that must be used as a system:

2009年2月19日 · “We have developed a novel combination medical device, called AMPLEX, that incorporates B2A osteo-inductive growth factor with an ultra-high grade ceramic bone substitute for use in this type of surgery. Preclinical studies have found that it is a safe and highly effective.”

2010年10月18日 · 当前的研究评估了一种名为 Amplex B2A (TM) 肽增强陶瓷颗粒（“Amplex”）的研究性医疗设备，用于足踝融合。 Amplex 是一种合成骨移植材料。 最常用的移植材料是从患者身上采...。 临床试验注册。 ICH GCP。

2008年11月24日 · This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.

For application in the foot and ankle, B2A peptide-coated ceramic granules have been reformatted into AMPLEX ® (Ferring Pharmaceuticals, Saint-Prex, Switzerland) with a coating concentration of 225 μg B2A/cm 3 ceramic granules (B2A-granule).

A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX® Compared To Autogenous Bone Graft. in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle. Trial Code: 000226. AMPLEX® (B2A® Enhanced Ceramic Granules) Click on the button below to navigate to the electronic system that you want to access.

2011年2月15日 · AMPLEX™ is an osteobiologic bone graft substitute that combines Bio SET’s proprietary B2A growth factor mimetic with a ceramic scaffold/carrier. B2A is a synthetic peptide that mimics the effect of bone morphogentic protein …

2013年3月5日 · B2A peptide-coated ceramic granules, with encouraging results in pilot studies of transforaminal lumbar interbody fusion, were here reformulated into Amplex with a coating concentration of 225...