Mirus announces US FDA 510(k) clearance for MoRe low-profile plating systems

Mirus has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance […]

Mirus has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its CYGNUS MoRe anterior cervical plate (ACP) and Mirus 3DR lateral lumbar interbody fusion system with integrated MoRe plate fixation—both of which, the company claims, are the narrowest and thinnest plating system among all plates on the global spine market.

MoRe, a proprietary molybdenum-rhenium superalloy for medical implants, provides an “unprecedented combination of strength, ductility, durability, and biological safety”, according to Mirus. The MoRe superalloy allows for the design of a new generation of smaller, stronger, more durable and bio-friendly implants that result in less soft tissue disruption, quicker recovery and better outcomes for patients, a recent company press release adds.

The proprietary molybdenum-rhenium alloy used in the integrated MoRe lateral plate allows for a “dramatically smaller footprint” of tapered 2mm thickness without sacrificing performance, the release further notes. In a lateral spinal fusion approach, whereby there is little room or empty space around the critical structures of the nerves and psoas, there is a “significant clinical benefit” from a plate that is 40–60% thinner than plates currently on the market, Mirus claims.

The integrated MoRe lateral plate was awarded the 2023 Spine Technology Award for its clinical relevance, clinical problem solving and likelihood of improving patient outcomes.

According to Mirus’ chief commercial officer, Mahesh Krishnan, the CYGNUS MoRe anterior cervical plate is a “world-class product” in the anterior cervical discectomy and fusion (ACDF) marketplace that furthers the company’s commitment to minimally invasive, stronger, biofriendly implants.

“With its thin, 1mm profile, the CYGNUS MoRe ACP will lead to less retraction and anterior vertebral body preparation, resulting in shorter operative times and minimising risk of complications such as dysphagia and dysphonia in patients undergoing anterior cervical fusion,” Krishnan added.

“Both the CYGNUS MoRe ACP and the Mirus 3DR lateral lumbar interbody fusion system with integrated MoRe plate fixation are major accomplishments in the global spine market, as we strive to develop products that are best in class with a resolve to provide meaningful innovations to surgeons that improve patient outcomes,” said Jay Yadav, the company’s founder and CEO.

Original Article: (https://spinalnewsinternational.com/mirus-announces-us-fda-510k-clearance-for-more-low-profile-plating-systems/)