FDA Nod for Integra Spine

Global provider of surgical implants and medical instruments, Integra LifeScience Holdings Corporation (IART - Snapshot Report) recently received the 510(k) clearance from the US Food and Drug Administration (FDA) for its path-breaking Integra Vu aPOD Prime Intervertebral Body Fusion Device (IBD), a zero profile IBD designed for anterior lumbar fusion (ALIF) procedures.

The company also showcased the product at the annual meeting of the American Association of Neurological Surgeons held between April 14 - 18, 2012 in Florida.

IBDs are small, hollow spinal implants that provide stability for spinal fusion after the surgical removal of a diseased lumbar disc. To restore the physiological disc height and allow fusion between vertebral bodies, these particles are inserted into the intervertebral space.

While conventionally surgeons need supplemental fixation to hold the IBD in place, this new Integra Vu aPOD Prime IBD does not require any support fixation as it offers zero-profile design with two screws to fix the IBD in its original place. As a result, compared to the traditional method, this requires less number of steps and implants to perform an ALIF procedure. Also, some surgeons claim this to reduce post-operative implant settling into the vertebral endplates.

During the span of controlled market release, this Integra Vu aPOD Prime IBD under the existing Integra spine portfolio was largely accepted among the surgeons. Thus the latest full market launch is expected to further strengthen the company’s spinal products range, thereby improving the company’s performance going forward.

Moreover, this product is set to be a strategic fit within Integra’s fastest growing orthopedic segment as the company itself has been pursuing the development of implants and orthobiologics used in spinal surgery across the world. Integra's lumbar interbody portfolio already includes Hollywood IBD, PacificaIBD, Redondo IBD, Ventura IBD, Vu ePOD IBD, Vu LPOD IBD and the Zuma fixation system.

We are encouraged by the company’s focus on strategic initiatives to drive growth and profitability in the orthopedic market. Several initiatives on the company’s part like planned product launches and acquisitions are expected to accelerate sales growth in the next several quarters.

However, the challenging macroeconomic environment in Europe and continued softness in the US remain as a major headwind. The company is also facing stiff competition from large-cap players like Medtronic (MDT - Analyst Report), Johnson & Johnson (JNJ - Analyst Report) and Stryker Corp. (SYK - Analyst Report) in the orthobiologic and spine market.

Currently, Integra retains a Zacks #3 Rank (Short-term Hold). Considering the company’s business model and fundamentals, we have a long-term Neutral recommendation on the stock.