Zimmer Debuts New Fusion Product, Reports Early Clinical Results

@font-face { font-family: “Arial”; }@font-face { font-family: “Cambria”; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: “Times New Roman”; }div.Section1 { page: Section1; }As the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) entered the home stretch in (sometimes) sunny San Diego, Calif., Zimmer Holdings, Inc., unveiled a new product launch and some positive early clinical findings.

@font-face { font-family: “Arial”; }@font-face { font-family: “Cambria”; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: “Times New Roman”; }div.Section1 { page: Section1; } @font-face { font-family: “Arial”; }@font-face { font-family: “Cambria”; }p.MsoNormal, li.MsoNormal, div.MsoNormal { margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: “Times New Roman”; }div.Section1 { page: Section1; }

As the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) entered the home stretch in (sometimes) sunny San Diego, Calif., Zimmer Holdings, Inc., unveiled a new product launch and some positive early clinical findings.

On the product approval side, the company received clearance from the U.S. Food and Drug Administration for its TM-S Trabecular Metal cervical interbody fusion device, which company officials claim is the first such product to incorporate porous metal technology, and the first Zimmer Trabecular Metal device for cervical interbody fusion in the United States.

The TM-S system is made using Zimmer’s proprietary Trabecular Metal Technology, a unique porous metal biomaterial with structural and mechanical properties similar to cancellous bone. Trabecular Metal Material provides a scaffold that supports bony in-growth and vascularization into the implant.

“With the introduction of the TM-S system, Zimmer is bringing the potential benefits of porous metal technology to cervical interbody fusion,” said Steve Healy, president, Zimmer Spine. “The osteoconductive properties of Trabecular Metal Technology support initial fixation and can potentially aid in cervical fusion.”

The TM-S Cervical Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The device is designed to treat the cervical spine of patients with degenerative disc disease with or without radicular symptoms at one level from C2-T1.

During this year’s AAOS, Zimmer also shared the results from a peer-reviewed publication demonstrating positive outcomes from the first surgery performed using the firm’s DeNovo NT Graft for the repair of cartilage lesions. The report includes both two-year patient outcome measures and 21-month follow-up MRI data. .

Published in The Journal of Knee Surgery, the case report described clinical success with Zimmer’s DeNovo NT Graft after two years of implantation when used to treat a symptomatic cartilage lesion in the patella. The case study reports that the implantation of DeNovo NT Graft resulted in substantial clinical improvement in both pain and function through two years. MRI data demonstrated that the treated defect was filled with repair tissue which resulted in a near complete resolution of pre-operative subchondral bone edema, according to Zimmer officials, who called the study a “significant milestone.”

DeNovo NT Graft is a juvenile cartilage allograft tissue implant, which provides an early intervention option for the repair of articular cartilage. It consists of particulated articular cartilage with actual living cells. The DeNovo NT Graft offers a single-stage procedure to treat articular cartilage defects in a wide range of anatomical applications including those for the knee, ankle, hip, shoulder or elbow.

DeNovo NT Graft was developed in conjunction with ISTO Technologies, Inc. as part of the companies’ strategic partnership.

Rounding out Zimmer’s announcements during AAOS, the company’s trauma business released early clinical results from the first patients treated with Zimmer MotionLoc screws. According to the company, early results showed that patients were free of complications. The screw is the company’s latest installment in locking plate technology and is intended for use in conjunction with Zimmer’s NCB polyaxial locking plate system.

A total of ten patients were treated using the Zimmer MotionLoc Screws between October 2010 and January 2011, and postoperatively, surgeons reported no complications in implant application, implant fixation or fracture healing.

The screw and locking plate system is intended to treat complex, long-bone fractures, such as those of the femur, tibia or humerus. According to the company, the technology enables the surgeon to reduce the stiffness of the locking plate construct while still maintaining the strength needed until the fracture begins to heal. MotionLoc technology is based on the concept of far cortical locking, which may reduce the stiffness of locked plating constructs while still retaining the construct’s strength.

Jeff Paulsen, group president, Zimmer Global Businesses, called the screw “a game-changer” for surgeons without drastically altering their surgical procedure.

Zimmer officials said surgeons commented that insertion and removal of the Zimmer MotionLoc Screws felt normal and the procedures did not require additional effort compared to standard screw insertion.

Warsaw, Ind., Zimmer has operations in more than 25 countries and more than 8,000 employees. Zimmer’s 2010 sales were approximately $4.2 billion.