Biography

Hugues Malandain has been focused on the development of Orthopedic Devices since 1998. After a few line additions in degenerative spine while working for Sofamor Danek (Paris, France), he launched his first pedicle screw system, Equation™, which he later transferred to the headquarter (Memphis, TN), where he obtained his first 510(K) in 2001. An avant grade system, Equation™ offered a construct with variable stiffness.

Hugues true passion for the treatment of spinal disorder came after he developed with Dr. Larry Lenke, leading expert in complex deformity surgery, the first and truly pediatric deformity system, Legacy™ 3.5, designed for infants with severe scoliosis.

Moving to California in 2003 to join Kyphon (Sunnyvale, CA), he was tasked with investigating various opportunities and evaluating potential solutions for a number of spinal pathologies. His effort led the company in the treatment of spinal stenosis with Aperius™, a percutaneous device capable of treating patient under local anesthesia, offering indirect decompression of the central and lateral foramen. Being percutaneous, the system reduced the procedural time from 45 minutes for a single level to 15-30 minutes depending on the number of levels treated. Medtronic later acquired Kyphon.

Remaining in the Silicon Valley, he joined Dr. Todd Alamin, Orthopedic Surgeon at Stanford University in his effort with Simpirica Spine (Redwood City, CA), a start-up company focused on the development of a minimally invasive dynamic stabilization of the spine post bony decompression. The product was launched in Europe and demonstrated great results and phenomenal potential.

In 2008, Hugues developed the first and only monolithic titanium expandable interbody device on the market. Spine Wave acquired the technology in 2012 and "Leva" was born. To date, the implant is the only one to allow the surgeon to post pack the disc space with an average of 15cc of bone graft, a crucial attribute in order to obtain solid arthrodesis. Leva earned the name of "expandable graft chamber".

With a constant focus on Simplicity, Elegance and Cost Effectiveness, it is safe to say that the surgeons are empowered to do the best job they can, the patients recover faster, and the medical device community continue to make strides forward! This is what it is all about.