FDA OKs Elute’s BonVie+ Synthetic, Resorbable Bone Void Filler

Elute has received U.S. Food and Drug Administration (FDA) clearance for BonVie+, its novel bone void filler implant.

Treating bone voids and restoring bone loss includes surgical debridement, followed by filling the voids with a synthetic bone graft substitute material like bone cement or calcium sulfate-based granules. However, both materials offer some disadvantages.

Bone cement is not biodegradable and doesn’t support bone growth, and in most cases needs another surgery to remove the beads and subsequent bone grafting. Calcium sulfate-based bone graft substitutes are biodegradable, but are known to cause seromas and lead to significant wound drainage.

Elute has enhanced its resorbable bone graft technology with BonVie+, which is designed for controlled resorption and replacement by new bone. The calcium-sale bone void filler implant is used to fill bone defects, and with time is replaced by new bone into the space previously occupied by the implant.

“This new era in resorbable bone graft fillers represents over a decade of innovation, equipping clinicians with unparalleled consistency in bone restoration and predictable clinical results,” said Ashok Khandkar, CEO of Elute.

Amar Ranawat, MD, Professor of Clinical Orthopedic Surgery, Weill Cornell Medical College and attending surgeon at the Hospital for Special Surgery said BonVie+ is a promising new product that overcomes the limitations of today’s bone graft substitutes.

“This new alternative in the treatment and management of bone defects and should greatly benefit patients in need for bone restoration,” Dr. Ranawat told the press.