LDR Mobi-C Cervical Disk May Soon be First Dual Level Implant Available in U.S.

LDR Mobi-C Cervical Disk May Soon be First Dual Level Implant Available in U.S.

LDR Receives Approvable Letter from U.S. Food and Drug Administration for Two-­Level Mobi-C® Cervical Disc

Mobi-C is the first cervical disc to receive an approvable letter for two-level use in the United States following a 600 patient concurrent IDE Clinical Trial for one and two-level cervical disc replacement

LDR Receives Approvable Letter from U.S. Food and Drug Administration for Two-­Level Mobi-C® Cervical Disc

AUSTIN, TX (November 6, 2012) – LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, announced that it has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its Mobi-C® Cervical Disc (Mobi-C). Mobi-C is a metal and polyethylene mobile bearing prosthesis specifically designed as a low-profile cervical intervertebral disc replacement for both one and two level applications.

“We are pleased that the FDA, after an intensive review of our submission for Mobi-C, has determined it to be approvable based on the strength of the data provided in the premarket approval application (PMA). We are confident that we can efficiently complete the remaining requirements inherent in the full approval process and we anticipate commercial U.S. availability of Mobi-C in 2013,” said Christophe Lavigne, President and CEO of LDR. “Given the high incidence of two-level cervical disease, we are proud that Mobi-C may become the first cervical disc available to treat patients on-label that suffer from two-level pathology. I would like to thank and attribute this success to everyone involved in this study, especially the clinicians, study coordinators, the FDA, LDR employees, our partners and suppliers, and most importantly the patients who consented to participate in the first prospective study performed comparing Mobi-C to ACDF.”

FDA has determined that Mobi-C is approvable for two-level indications, subject to the satisfaction of all applicable requirements of the Quality System Regulations (21 CFR Part 820), as well as finalization of the labeling and post-approval study. FDA will issue an approval order, allowing commercial sale and distribution, after said requirements have been reviewed and determined to be acceptable.

“The Mobi-C two-level study data, as presented at the North American Spine Society (NASS) 2012 Annual Meeting, demonstrate the potential to treat two-level cervical disease using the Mobi-C Cervical Disc as an alternative to ACDF,” said Dr. Reginald Davis, Chief of Neurosurgery and Director of Neurosciences at the Greater Baltimore Medical Center. “The anticipated full approval of Mobi-C will give surgeons a valuable treatment option for patients with two-level disease, where there is no approved motion preserving option.”

About LDR

LDR develops unique implantable spine devices and instrumentation designed to support the clinical goals of surgery while making procedures easier to perform. LDR was founded in 2000 by partners Christophe Lavigne, Hervé Dinville and Patrick Richard in Troyes, France. Headquartered in Austin, TX, LDR has experienced growth through product portfolio expansion and an increasingly global presence. More information is located at www.ldrmedical.com.

Caution: The Mobi-C® device is for investigational use only and is not available for use in the United States.

The Avenue L Lateral Lumber Cage System from LDR (Austin, TX) received 510(k) clearance, opening the way for the first lateral lumbar cage with integrated in-line plating to be sold in the U.S. The device has been on the market in Europe since 2010.

Designed to stabilize lumbar spinal segments to promote fusion, the device offers the company’s proprietary in-line, self-guided VerteBRIDGE plating technology, which has been used in more than 25,000 cage implantation procedures since it debuted in 2008.

The Avenue L Lateral Lumbar Cage System is intended for intervertebral body fusion of the lumbar spine, from the L2 to S1 vertebrae. The intervertebral cages in the device are made from PEEK OPTIMA Lii (ASTM F2026) and titanium alloy markers to enhance X-ray imaging. The system must be used with posterior supplemental fixation such as pedicle screws.

From the press release:

The Avenue L cage and self-guided, curved VerteBRIDGE plating are delivered in the plane of the disc through a minimally invasive direct lateral approach, so that the implantation may be achieved with less exposure than may be required of other lateral systems with integrated screws that must be inserted at divergent angles. The system features thoughtfully designed instrumentation including an inserter that protects anatomical structures while implanting the cage and plating. Avenue L has been implanted via a pre-psoatic approach without neurological monitoring in Europe, and is also compatible with the direct lateral trans-psoatic approach common in the United States.

The controlled mobility of the mobile insert is the foundation of the Mobi-C® disc prosthesis. This second generation artificial disc was designed by a team of surgeons specializing in spinal arthroplasty.

Mobi-C has a unique, reliable and patented implantation system: the « Plug & Fit » technology.

It provides you with an ease of use and modularity unequaled in the domain of cervical arthroplasty while preserving the core philosophy of Mobi-C: the resoration of physiological biomecanics with a controlled mobility insert.

LDR Medical (Austin, Texas) received an Approval Letter from the FDA paving way for the company’s Mobi-C metal and polyethylene cervical disk mobile bearing prosthesis to come U.S. to market. This would be the first cervical implant available in America to treat two adjacent levels of damaged disks.

The Mobi-C is applicable for both one and two level procedures, and the company touts its low-profile, easy control for the surgeon, and reliable anchorage.

FDA has determined that Mobi-C is approvable for two-level indications, subject to the satisfaction of all applicable requirements of the Quality System Regulations (21 CFR Part 820), as well as finalization of the labeling and post-approval study. FDA will issue an approval order, allowing commercial sale and distribution, after said requirements have been reviewed and determined to be acceptable.

“The Mobi-C two-level study data, as presented at the North American Spine Society (NASS) 2012 Annual Meeting, demonstrate the potential to treat two-level cervical disease using the Mobi-C Cervical Disc as an alternative to ACDF,” said Dr. Reginald Davis, Chief of Neurosurgery and Director of Neurosciences at the Greater Baltimore Medical Center. “The anticipated full approval of Mobi-C will give surgeons a valuable treatment option for patients with two-level disease, where there is no approved motion preserving option.”

source : http://www.ldrmedical.com/News/ArtMID/944/ArticleID/196/LDR-Receives-Approvable-Letter-from-US-Food-and-Drug-Administration-for-Two-%C2%ADLevel-Mobi-C%C2%AE-Cervical-Disc

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