Monday November 23, 2020 0 comments
FORT COLLINS -- Armis Biopharma, Inc. announced the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance for the VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
VeriFixx is designed to make surgical corrections of this kind more accessible to patients through shorter time to ambulation, shorter overall recovery time and reduced pain, Armis said.
"For patients requiring a small bone implant, the length of recovery and pain are common concerns," said Ted Ziemann, chair and CEO of Armis Biopharma.
"With our unique proprietary design, we are excited to bring a new technology to the medical device market that specifically addresses these concerns while maintaining the benefits of current standard of care."
Armis said VeriFixx incorporates a unique alignment fin design and a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition.
It is designed to provide ideal fixation alignment and a bone-friendly titanium surface, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for postoperative imaging.
In the U.S., there are approximately 500,000 small bone implant procedures each year. Overwhelmingly, the majority of patients are middle-aged women, Armis said.