Life Spine Receives FDA 510(k) Clearance for LONGBOW Titanium Lateral Expandable Spacer System, Advancing Minimally Invasive Spinal Surgery

VCBeat (WeChat ID: vcbeat) learned from foreign media reports that on November 21, 2019 (local time), medical device company Life Spine announced that its LONGBOW Titanium Transversely Expandable Interbody System (hereinafter referred to as the LONGBOW System) had received FDA 510(k) clearance.

Headquartered in Huntley, Illinois, USA, Life Spine is a medical device company specializing in the research and development of orthopedic and neurosurgical devices. Centered on patient needs, Life Spine primarily develops a product portfolio focused on spinal fusion and minimally invasive surgical procedures. The company aims to enhance procedural efficiency and optimize device functionality through innovatively designed products, rigorous quality standards, and an advanced technical team, thereby improving the quality of life for patients with spinal disorders.

It is reported that in June this year, Life Spine announced FDA approval for the market launch of its PROLIFT laterally expandable interbody system. The PROLIFT system utilizes OSSEO-LOC™ surface technology to provide minimally invasive solutions for TLIF (Transforaminal Lumbar Interbody Fusion) and PLIF (Posterior Lumbar Interbody Fusion). Through 6 mm of in situ expansion, the PROLIFT system facilitates disc space preparation and neural decompression. The LONGBOW system represents an extended research and development effort by Life Spine based on the PROLIFT platform.

The LONGBOW System is the first interbody spacer on the market capable of in-situ lateral expansion. Designed to minimize tissue retraction and potential nerve injury, the LONGBOW System reduces retraction by up to 45% compared to the PROLIFT System, simplifies the insertion process for bone grafts following dilation, and enhances intraoperative visualization when using tantalum, an radiopaque marker.

The LONGBOW System also incorporates Life Spine’s proprietary OSSEO-LOC™ surface technology. The LONGBOW System is available in lengths ranging from 45 to 60 mm and heights ranging from 9 to 15 mm, with a width that expands anteriorly from 15 mm to 27 mm. It offers 0° and 7° lordotic options. The system can be filled with graft material after in situ expansion, providing up to 11 cc of graft volume within the implant.

Rich Mueller, Chief Operating Officer of Life Spine, stated, “We are pleased to announce the launch of the titanium alloy version of the LONGBOW Expandable Lateral Interbody System, the first of its kind on the market, which is designed to achieve surgical goals previously unattainable. The spacer enables a maximum anterior-to-posterior expansion of 12 mm, allowing for an inserted footprint as small as 15 mm, yet once expanded, it occupies a space more comparable to that of an ALIF (Anterior Lumbar Interbody Fusion) spacer than traditional lateral spacers.”

(Compiled by Zhao Siyun)