Le Lézard
Classified in: Health
Subject: FDA

Neo Medical lands both FDA approval and CE marking


LAUSANNE, Switzerland, June 16, 2021 /PRNewswire/ -- Neo Medical, a Swiss-based Medtech company developing value-based care solutions for Functional Fusion in spinal surgery, announced today two major regulatory milestones for the European and the US markets.

Neo Medical logo

First, Neo Medical received FDA 510(k) clearance for the use of its Pedicle Screw System in late stage tumour indications in combination with BonOs® Inject cement from OSARTIS[1]. This additional FDA 510(k) clearance for the Neo Pedicle Screw Systemtm enables US surgeons to take full advantage of Neo universal screw design and offer their patients the optimal treatment option when screw augmentation is desirable in this indication.

Second, next to the FDA 510(k) clearance, the company also obtained CE certification for its 8.0mm screws, iliac screws and connectors, as well as rod-to-rod connectors, thereby completing the universal offering of the Neo Pedicle Screw Systemtm.

Dr. Pierce D Nunley, MD, a prominent US spine surgeon and thought leader, commented on the FDA 510(k) clearance "The ability to augment screws with cement is an important treatment option for our patients with compromised bone quality in late stage tumour indication, which will improve patient care and decrease post-operative failures."

Speaking about the CE certification announced today, Dr. Louis Boissière, a French surgeon recognized for spinal deformity surgery and minimally invasive outpatient surgery, added "Neo's current platform allows me to treat very successfully all my degenerative, traumatic and tumour cases. The extended indications resulting from an expanded portfolio with iliac screws and connectors will allow strong pelvic fixations as well as in-block compression/distraction and multirods construct with the dominos. The complete Neo platform now provides me with a complete deformity platform to manage my most complex deformity surgical cases."

Vincent Lefauconnier, Neo Medical CEO, added about Neo Medical recent regulatory and products milestones, "The FDA 510(k) clearance and CE certification announced today come as we continue to expand our portfolio and develop new applications for NEO pedicle Screw systemtm. The rest of the year should see the company continuing to expand its activities, including in the digital space with the roll-out of groundbreaking augmented reality solutions to complement our existing platform of physical products."

About Neo Medical

Focusing on value-based care, Neo Medical develops a new generation of controlled-fixation solutions designed for a more Functional Fusion in spinal surgery, respectful of patients' unique spinal conditions. With only five multi-functional instruments covering most spine indications in a universal approach, the unique proprietary features of Neo Medical solutions ensure an anatomically neutral, balanced, and stable spine load bearing, to achieve a Functional Fusion. Neo Medical fixation solutions also provides everyone involved in spinal surgery with an easier and more efficient experience, and offers additional value by driving factors that limit infections, removing re-sterilization needs, de-cluttering the OR, reducing re-operation rates and the associated costs, while ultimately putting patients, practitioners, payers, providers, and society at large in control. Beyond providing solutions tailored to patients' needs, the Neo Medical value-based care approach participates in preserving the overall environmental sustainability of the broader healthcare system. For more information, please visit: https://www.neo-medical.com/en/index and follow Neo Medical on LinkedIn: @NeoMedical

[1] The FDA approval applies to NEO Pedicle Screws augmented with Bon Os® Inject Cement and used at spinal levels where the structural integrity of the spine is not severely compromised. BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw Systemtm is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumours involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion

Media Contacts:

Alphonse Daudré-Vignier
Weber Shandwick Switzerland
+41 79 127 63 58
Adaudre-vignier@webershandwick.com 

Logo - https://mma.prnewswire.com/media/1168475/Neo_Medical_Logo.jpg

 

 

SOURCE Neo Medical


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